Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05096312
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2021-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030691', 'term': 'gluconic acid'}, {'id': 'D000068816', 'term': 'Adapalene'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D000068801', 'term': 'Adapalene, Benzoyl Peroxide Drug Combination'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004338', 'term': 'Drug Combinations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'moniquelianne.lim@gmail.com', 'phone': '0287100957', 'title': 'Dr. Monqiue Lianne Lim-Ang', 'organization': 'East Avenue Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Zinc Gluconate Group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nZinc gluconate: oral zinc gluconate 200mg\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening\n\nPlacebo: contains cornstarch', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Acne Grading System Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc Gluconate Group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nZinc gluconate: oral zinc gluconate 200mg\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening\n\nPlacebo: contains cornstarch'}], 'classes': [{'title': 'Initial', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '25.67', 'upperLimit': '43'}, {'value': '30.33', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '38.33'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '21.67', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '29'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '36'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '14.34', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '24.67'}, {'value': '21.67', 'groupId': 'OG001', 'lowerLimit': '7.67', 'upperLimit': '27.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'upon enrollment, at 4 weeks, at 8 weeks', 'description': 'changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'type': 'PRIMARY', 'title': 'Inflammatory Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc Gluconate Group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nZinc gluconate: oral zinc gluconate 200mg\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening\n\nPlacebo: contains cornstarch'}], 'classes': [{'title': 'Initial', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '110.67'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '19.67', 'upperLimit': '72.33'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '22.67', 'groupId': 'OG000', 'lowerLimit': '12.67', 'upperLimit': '42.38'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '10.67', 'upperLimit': '73.67'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '8.34', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '32.33'}, {'value': '22.67', 'groupId': 'OG001', 'lowerLimit': '10.67', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'upon enrollment, at 4 weeks, at 8 weeks', 'description': 'changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'type': 'SECONDARY', 'title': "Examiner's Assessment Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc Gluconate Group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nZinc gluconate: oral zinc gluconate 200mg\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening\n\nPlacebo: contains cornstarch'}], 'classes': [{'categories': [{'title': 'No Improvement', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Slight Improvement (<50%)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked Improvement (≥50%)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 8 weeks', 'description': "examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (\\<50%), marked improvement (≥50%)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'type': 'SECONDARY', 'title': "Patient's Self-assessment Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc Gluconate Group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nZinc gluconate: oral zinc gluconate 200mg\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening\n\nPlacebo: contains cornstarch'}], 'classes': [{'categories': [{'title': 'No improvement', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Slight improvement (<50%)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked improvement (≥50%)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 8 weeks', 'description': "patient's assessment of acne improvement graded as no improvement (0%), slight improvement (\\<50%), marked improvement (≥50%)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zinc Gluconate Group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nZinc gluconate: oral zinc gluconate 200mg\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening\n\nPlacebo: contains cornstarch'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zinc Gluconate Group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nZinc gluconate: oral zinc gluconate 200mg\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.\n\nAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \\[Epiduo\\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening\n\nPlacebo: contains cornstarch'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Philippines', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'title': 'Inflammatory Score', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '110.67'}, {'value': '48.5', 'groupId': 'BG001', 'lowerLimit': '19.67', 'upperLimit': '72.33'}, {'value': '62.84', 'groupId': 'BG002', 'lowerLimit': '19.67', 'upperLimit': '110.67'}]}]}], 'paramType': 'MEDIAN', 'description': 'The inflammatory score is a grading system that measures inflammatory lesions (papules, pustules, nodules). Locations for assessment include the face, chest and back. For each location, papules, pustules and nodules are counted. A factor based on the lesion (papule=3, pustule=4, nodule=5) is multiplied to a grade equivalent to the number of lesions (0= No lesions, 1= 1-5 lesions, 2= 6-10 lesions, 3= 11-20 lesions, 4= more than 20 lesions).\n\nThe subtotal scores are added to come up with the total inflammatory score. A maximum possible total score of 144.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}, {'title': 'Global Acne Grading System score', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '25.67', 'upperLimit': '43'}, {'value': '30.33', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '38.33'}, {'value': '31.5', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Global Acne Grading System (GAGS) is an acne severity scale. A factor is provided for each location based on size (forehead=2, right cheek=2, left cheek=2, nose=1, chin=1, chest and upper back=3). Each location is graded based on the most severe lesion present (no lesion=0, comedones=1, papules=2, pustules=3, nodules=4). The local score per location is equal to location factor multiplied by the score for the most severe lesion. The sum of local scores for all locations is the global score. Acne is rated as mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}], 'populationDescription': 'the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-19', 'size': 190883, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-17T14:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2021-10-14', 'resultsFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-17', 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Acne Grading System Score', 'timeFrame': 'upon enrollment, at 4 weeks, at 8 weeks', 'description': 'changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39)'}, {'measure': 'Inflammatory Score', 'timeFrame': 'upon enrollment, at 4 weeks, at 8 weeks', 'description': 'changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.'}], 'secondaryOutcomes': [{'measure': "Examiner's Assessment Score", 'timeFrame': 'at 8 weeks', 'description': "examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (\\<50%), marked improvement (≥50%)"}, {'measure': "Patient's Self-assessment Score", 'timeFrame': 'at 8 weeks', 'description': "patient's assessment of acne improvement graded as no improvement (0%), slight improvement (\\<50%), marked improvement (≥50%)"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne vulgaris', 'zinc gluconate', 'inflammation', 'adapalene', 'benzoyl peroxide', 'Global Acne Grading System'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '23210645', 'type': 'BACKGROUND', 'citation': 'Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149.'}, {'pmid': '23032935', 'type': 'BACKGROUND', 'citation': 'Humphrey S. Antibiotic resistance in acne treatment. Skin Therapy Lett. 2012 Oct;17(9):1-3.'}, {'pmid': '25597339', 'type': 'BACKGROUND', 'citation': 'Tan JK, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. 2015 Jul;172 Suppl 1:3-12. doi: 10.1111/bjd.13462.'}, {'pmid': '17945383', 'type': 'BACKGROUND', 'citation': 'Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, Elewski BE. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008 Jan;58(1):56-9. doi: 10.1016/j.jaad.2007.06.045. Epub 2007 Oct 22.'}, {'pmid': '10495379', 'type': 'BACKGROUND', 'citation': 'Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.'}, {'pmid': '29127053', 'type': 'BACKGROUND', 'citation': 'Thiboutot DM, Dreno B, Abanmi A, Alexis AF, Araviiskaia E, Barona Cabal MI, Bettoli V, Casintahan F, Chow S, da Costa A, El Ouazzani T, Goh CL, Gollnick HPM, Gomez M, Hayashi N, Herane MI, Honeyman J, Kang S, Kemeny L, Kubba R, Lambert J, Layton AM, Leyden JJ, Lopez-Estebaranz JL, Noppakun N, Ochsendorf F, Oprica C, Orozco B, Perez M, Piquero-Martin J, See JA, Suh DH, Tan J, Lozada VT, Troielli P, Xiang LF. Practical management of acne for clinicians: An international consensus from the Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2018 Feb;78(2 Suppl 1):S1-S23.e1. doi: 10.1016/j.jaad.2017.09.078. Epub 2017 Nov 8.'}, {'pmid': '26945741', 'type': 'BACKGROUND', 'citation': 'Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.'}, {'pmid': '24795060', 'type': 'BACKGROUND', 'citation': 'Al-Shobaili HA. Oxidants and anti-oxidants status in acne vulgaris patients with varying severity. Ann Clin Lab Sci. 2014 Spring;44(2):202-7.'}, {'pmid': '2187766', 'type': 'BACKGROUND', 'citation': 'Bray TM, Bettger WJ. The physiological role of zinc as an antioxidant. Free Radic Biol Med. 1990;8(3):281-91. doi: 10.1016/0891-5849(90)90076-u.'}, {'pmid': '25988117', 'type': 'BACKGROUND', 'citation': 'Prasad AS. Zinc is an Antioxidant and Anti-Inflammatory Agent: Its Role in Human Health. Front Nutr. 2014 Sep 1;1:14. doi: 10.3389/fnut.2014.00014. eCollection 2014.'}, {'pmid': '12358835', 'type': 'BACKGROUND', 'citation': 'Rostan EF, DeBuys HV, Madey DL, Pinnell SR. Evidence supporting zinc as an important antioxidant for skin. Int J Dermatol. 2002 Sep;41(9):606-11. doi: 10.1046/j.1365-4362.2002.01567.x.'}, {'pmid': '24350859', 'type': 'BACKGROUND', 'citation': 'Sardana K, Chugh S, Garg VK. The role of zinc in acne and prevention of resistance: have we missed the "base" effect? Int J Dermatol. 2014 Jan;53(1):125-7. doi: 10.1111/ijd.12264. No abstract available.'}, {'pmid': '4095368', 'type': 'BACKGROUND', 'citation': 'Buxaderas SC, Farre-Rovira R. Whole blood and serum zinc levels in relation to sex and age. Rev Esp Fisiol. 1985 Dec;41(4):463-70.'}, {'pmid': '6217164', 'type': 'BACKGROUND', 'citation': 'Amer M, Bahgat MR, Tosson Z, Abdel Mowla MY, Amer K. Serum zinc in acne vulgaris. Int J Dermatol. 1982 Oct;21(8):481-4. doi: 10.1111/j.1365-4362.1982.tb03188.x.'}, {'pmid': '27407419', 'type': 'BACKGROUND', 'citation': 'Arora PN, Dhillon KS, Rajan SR, Sayal SK, Das AL. Serum Zinc Levels in Cutaneous Disorders. Med J Armed Forces India. 2002 Oct;58(4):304-6. doi: 10.1016/S0377-1237(02)80083-1. Epub 2011 Jul 21.'}, {'pmid': '25157359', 'type': 'BACKGROUND', 'citation': 'Rostami Mogaddam M, Safavi Ardabili N, Maleki N, Soflaee M. Correlation between the severity and type of acne lesions with serum zinc levels in patients with acne vulgaris. Biomed Res Int. 2014;2014:474108. doi: 10.1155/2014/474108. Epub 2014 Jul 24.'}, {'pmid': '139912', 'type': 'BACKGROUND', 'citation': 'Michaelsson G, Vahlquist A, Juhlin L. Serum zinc and retinol-binding protein in acne. Br J Dermatol. 1977 Mar;96(3):283-6. doi: 10.1111/j.1365-2133.1977.tb06138.x.'}, {'pmid': '23826827', 'type': 'BACKGROUND', 'citation': 'Ozuguz P, Dogruk Kacar S, Ekiz O, Takci Z, Balta I, Kalkan G. Evaluation of serum vitamins A and E and zinc levels according to the severity of acne vulgaris. Cutan Ocul Toxicol. 2014 Jun;33(2):99-102. doi: 10.3109/15569527.2013.808656. Epub 2013 Jul 5.'}, {'pmid': '25120566', 'type': 'BACKGROUND', 'citation': 'Gupta M, Mahajan VK, Mehta KS, Chauhan PS. Zinc therapy in dermatology: a review. Dermatol Res Pract. 2014;2014:709152. doi: 10.1155/2014/709152. Epub 2014 Jul 10.'}, {'pmid': '20510767', 'type': 'BACKGROUND', 'citation': 'Bae YS, Hill ND, Bibi Y, Dreiher J, Cohen AD. Innovative uses for zinc in dermatology. Dermatol Clin. 2010 Jul;28(3):587-97. doi: 10.1016/j.det.2010.03.006.'}, {'pmid': '16971312', 'type': 'BACKGROUND', 'citation': 'Bibi Nitzan Y, Cohen AD. Zinc in skin pathology and care. J Dermatolog Treat. 2006;17(4):205-10. doi: 10.1080/09546630600791434.'}, {'pmid': '145237', 'type': 'BACKGROUND', 'citation': 'Michaelsson G, Juhlin L, Ljunghall K. A double-blind study of the effect of zinc and oxytetracycline in acne vulgaris. Br J Dermatol. 1977 Nov;97(5):561-6. doi: 10.1111/j.1365-2133.1977.tb14136.x.'}, {'pmid': '11586012', 'type': 'BACKGROUND', 'citation': 'Dreno B, Moyse D, Alirezai M, Amblard P, Auffret N, Beylot C, Bodokh I, Chivot M, Daniel F, Humbert P, Meynadier J, Poli F; Acne Research and Study Group. Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris. Dermatology. 2001;203(2):135-40. doi: 10.1159/000051728.'}, {'pmid': '159714', 'type': 'BACKGROUND', 'citation': 'Cunliffe WJ, Burke B, Dodman B, Gould DJ. A double-blind trial of a zinc sulphate/citrate complex and tetracycline in the treatment of acne vulgaris. Br J Dermatol. 1979 Sep;101(3):321-5. doi: 10.1111/j.1365-2133.1979.tb05626.x.'}, {'pmid': '2575335', 'type': 'BACKGROUND', 'citation': 'Dreno B, Amblard P, Agache P, Sirot S, Litoux P. Low doses of zinc gluconate for inflammatory acne. Acta Derm Venereol. 1989;69(6):541-3.'}, {'pmid': '146511', 'type': 'BACKGROUND', 'citation': 'Hillstrom L, Pettersson L, Hellbe L, Kjellin A, Leczinsky CG, Nordwall C. Comparison of oral treatment with zinc sulphate and placebo in acne vulgaris. Br J Dermatol. 1977 Dec;97(6):681-4. doi: 10.1111/j.1365-2133.1977.tb14277.x.'}, {'pmid': '82356', 'type': 'BACKGROUND', 'citation': 'Goransson K, Liden S, Odsell L. Oral zinc in acne vulgaris: a clinical and methodological study. Acta Derm Venereol. 1978;58(5):443-8.'}, {'pmid': '6163281', 'type': 'BACKGROUND', 'citation': 'Verma KC, Saini AS, Dhamija SK. Oral zinc sulphate therapy in acne vulgaris: a double-blind trial. Acta Derm Venereol. 1980;60(4):337-40. doi: 10.2340/0001555560337340.'}, {'pmid': '20666829', 'type': 'BACKGROUND', 'citation': 'Sardana K, Garg VK. An observational study of methionine-bound zinc with antioxidants for mild to moderate acne vulgaris. Dermatol Ther. 2010 Jul-Aug;23(4):411-8. doi: 10.1111/j.1529-8019.2010.01342.x.'}, {'pmid': '82355', 'type': 'BACKGROUND', 'citation': 'Vahlquist A, Michaelsson G, Juhlin L. Acne treatment with oral zinc and vitamin A: effects on the serum levels of zinc and retinol binding protein (RBP). Acta Derm Venereol. 1978;58(5):437-42.'}, {'pmid': '15908296', 'type': 'BACKGROUND', 'citation': 'Dreno B, Foulc P, Reynaud A, Moyse D, Habert H, Richet H. Effect of zinc gluconate on propionibacterium acnes resistance to erythromycin in patients with inflammatory acne: in vitro and in vivo study. Eur J Dermatol. 2005 May-Jun;15(3):152-5.'}, {'pmid': '17951128', 'type': 'BACKGROUND', 'citation': 'Jarrousse V, Castex-Rizzi N, Khammari A, Charveron M, Dreno B. Zinc salts inhibit in vitro Toll-like receptor 2 surface expression by keratinocytes. Eur J Dermatol. 2007 Nov-Dec;17(6):492-6. doi: 10.1684/ejd.2007.0263. Epub 2007 Oct 19.'}], 'seeAlsoLinks': [{'url': 'https://ods.od.nih.gov/factsheets/Zinc-HealthProfessional/', 'label': 'NIH Zinc fact sheet'}, {'url': 'https://go.drugbank.com/drugs/DB11248', 'label': 'Drug Bank zinc gluconate'}, {'url': 'https://examine.com/supplements/zinc/', 'label': 'summary of zinc'}, {'url': 'https://supplementsinreview.com/testosterone/zinc-testosterone/', 'label': 'Zinc for testosterone'}, {'url': 'https://bijps.uobaghdad.edu.iq/index.php/bijps/article/view/474', 'label': 'Serum Trace Elements (Zinc, Copper and Magnesium) Status in Iraqi Patients with Acne Vulgaris: (Case- Controlled Study)'}, {'url': 'http://scinet.science.ph/union/Downloads/Fil-361265_361265.pdf', 'label': 'A Cross-Sectional Study on the Impact of Acne Vulgaris on the Quality of Life among High School Students in Pasig City, Philippines'}]}, 'descriptionModule': {'briefSummary': 'Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has been described.\n\nA randomized, double blind, placebo-controlled clinical trial was utilized for this study with the objective to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients as measured by the inflammatory score and Global Acne Grading System (GAGS) score.', 'detailedDescription': 'Acne has four main pathogenic contributors: follicular hyperkeratinization, increased sebum production, Propionibacterium acnes (P. acnes) within the follicle, and inflammation. Treatment options for acne vulgaris include benzoyl peroxide, topical and oral retinoids, topical and oral antimicrobials, oral corticosteroids, and physical modalities such as acne surgery, laser and light therapy. Reports show that antibiotic resistance is a growing issue in the treatment regimen of acne vulgaris, making it less and less suitable for long-term treatment, hence other options that can be substitutes or adjuncts to treatment may be useful in this condition. For long-term or maintenance therapy, physicians should consider effectivity, cost, and adverse effects. Several studies have explored the effect of oral zinc on acne vulgaris. Since zinc is more cost-effective and has less adverse effects compared to most antibiotics, this may prove helpful for the Filipino patient in terms of safety and economy for long-term therapy.\n\nThe aim of this study is to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients, to determine the demographic and clinical profile of Acne Vulgaris patients, to determine the disease activity measured by the inflammatory score and GAGS score of acne vulgaris patients on initial consult, at 4 weeks, and at 8 weeks, and to determine if there is a significant difference in disease activity as measured by the inflammatory score and GAGS score among acne vulgaris patients given placebo and oral zinc gluconate.\n\nA randomized, double blind, placebo-controlled clinical trial was utilized. Adults with moderate to severe acne vulgaris were included in the study. Patients were evaluated using the inflammatory score and Global Acne Grading System (GAGS) at the start, at midpoint, and at the end of the trial. One group of participants received zinc gluconate supplementation and another group received placebo for 60 days. All participants received topical adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening. Improvement in acne severity was then determined and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '27 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Filipino patients, aged 18-27 years old\n* New patients diagnosed with Acne Vulgaris with a Global Acne Grading System score of at least 19\n* Able to read and write in English or Tagalog\n* Seen at the Dermatology out-patient clinic of East Avenue Medical Center\n\nExclusion Criteria:\n\n* Patients with other chronic dermatoses or systemic disease\n* Taking oral supplements or medications within the past 4 weeks\n* Patients who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT05096312', 'briefTitle': 'Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'East Avenue Medical Center, Philippines'}, 'officialTitle': 'A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients', 'orgStudyIdInfo': {'id': 'EAMC IERB 2018-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zinc gluconate group', 'description': 'interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.\n\nAdapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.', 'interventionNames': ['Dietary Supplement: Zinc gluconate', 'Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.', 'interventionNames': ['Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]', 'Other: Placebo']}], 'interventions': [{'name': 'Zinc gluconate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Solgar zinc gluconate'], 'description': 'oral zinc gluconate 200mg', 'armGroupLabels': ['Zinc gluconate group']}, {'name': 'Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]', 'type': 'DRUG', 'otherNames': ['Epiduo Forte'], 'description': 'Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening', 'armGroupLabels': ['Placebo group', 'Zinc gluconate group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'contains cornstarch', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'East Avenue Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}], 'overallOfficials': [{'name': 'Monique Lianne C. Lim-Ang, MD,MBA,DPDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Avenue Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Avenue Medical Center, Philippines', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Monique Lianne C. Lim-Ang, MD, MBA, DPDS', 'investigatorAffiliation': 'East Avenue Medical Center, Philippines'}}}}