Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-24 @ 9:26 PM
Study NCT ID:
NCT04105504
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Glutathione As A Skin Whitening Agent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005978', 'term': 'Glutathione'}], 'ancestors': [{'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Spot UV at 4 weeks', 'timeFrame': '4 weeks', 'description': 'Total reduction (improvement) of spot UV'}, {'measure': 'Change from Baseline Spot Polarization at 4 weeks', 'timeFrame': '4 weeks', 'description': 'Total reduction (improvement) of spot polarization'}, {'measure': 'Change from Baseline Skin Tone at 4 weeks', 'timeFrame': '4 weeks', 'description': 'Improvement of skin tone'}, {'measure': 'Change from Baseline Spot UV at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Total reduction (improvement) of spot UV'}, {'measure': 'Change from Baseline Spot Polarization at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Total reduction (improvement) of spot polarization'}, {'measure': 'Change from Baseline Skin Tone at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Improvement of skin tone'}, {'measure': 'Change from Baseline Spot UV at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Total reduction (improvement) of spot UV'}, {'measure': 'Change from Baseline Spot Polarization at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Total reduction (improvement) of spot polarization'}, {'measure': 'Change from Baseline Skin Tone at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Improvement of skin tone'}], 'secondaryOutcomes': [{'measure': 'Subjective Improvement at 4 weeks', 'timeFrame': '4 weeks', 'description': 'Subjects were asked to grade the overall response using rating scale with a multiple-choice question:\n\n1. minimal improvement\n2. moderate improvement\n3. good improvement\n4. excellent improvement\n\nNote: The higher improvement represents a better outcome.'}, {'measure': 'Adverse events at 4 weeks', 'timeFrame': '4 weeks', 'description': 'Adverse events related to therapy'}, {'measure': 'Subjective Improvement at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Subjects were asked to grade the overall response using rating scale with a multiple-choice question:\n\n1. minimal improvement\n2. moderate improvement\n3. good improvement\n4. excellent improvement\n\nNote: The higher improvement represents a better outcome.'}, {'measure': 'Adverse events at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Adverse events related to therapy'}, {'measure': 'Subjective Improvement at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Subjects were asked to grade the overall response using rating scale with a multiple-choice question:\n\n1. minimal improvement\n2. moderate improvement\n3. good improvement\n4. excellent improvement\n\nNote: The higher improvement represents a better outcome.'}, {'measure': 'Adverse events at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Adverse events related to therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glutathione', 'whitening'], 'conditions': ['Glutathione', 'Skin Whitening']}, 'referencesModule': {'references': [{'pmid': '34840651', 'type': 'DERIVED', 'citation': 'Sitohang IBS, Anwar AI, Jusuf NK, Arimuko A, Norawati L, Veronica S. Evaluating Oral Glutathione Plus Ascorbic Acid, Alpha-lipoic Acid, and Zinc Aspartate as a Skin-lightening Agent: An Indonesian Multicenter, Randomized, Controlled Trial. J Clin Aesthet Dermatol. 2021 Jul;14(7):E53-E58. Epub 2021 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.', 'detailedDescription': 'The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent.\n\nThe study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.\n\nNinety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit.\n\nAt each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects with skin type Fitzpatrick IV and V\n* Women aged from 30 to 55 years with an understanding of all the information given by a written consent form\n* Working indoor office jobs (for minimum 8 hours)\n\nExclusion Criteria:\n\n* Personal or family history of skin cancer, especially melanoma\n* Consumption of any preparations containing glutathione within 1 month of enrollment\n* Use of any topical skin brightening or whitening preparations within 1 month of enrollment\n* Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas\n* A pregnant or breastfeeding mother\n* Personal history of drug allergy or skin disorder due to side effects of oral therapy'}, 'identificationModule': {'nctId': 'NCT04105504', 'briefTitle': 'Oral Glutathione As A Skin Whitening Agent', 'organization': {'class': 'OTHER', 'fullName': 'Rumah Sakit Pusat Angkatan Darat Gatot Soebroto'}, 'officialTitle': 'Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'RCTGlutathione'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glutathione Group', 'description': 'Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.', 'interventionNames': ['Drug: Glutathione']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects were randomised to receive Placebo capsules, which were identical in appearance and packaged in identical-looking containers with the Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Glutathione', 'type': 'DRUG', 'otherNames': ['L-Gluthatione'], 'description': 'Oral glutathione capsule (500 mg), were taken once daily by the subjects.', 'armGroupLabels': ['Glutathione Group']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Placebo oral capsule were taken once daily by the subjects.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'country': 'Indonesia', 'facility': 'Faculty of Medicine, Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Irma Bernadette S Sitohang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) - Head of Cosmetic Dermatology Division of Dermatology and Venereology Department of Faculty of Medicine Universitas Indonesia / Cipto Mangunkusumo Hospital', 'investigatorFullName': 'Dr Irma Bernadette S Sitohang', 'investigatorAffiliation': 'Rumah Sakit Pusat Angkatan Darat Gatot Soebroto'}}}}