Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01038869
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2009-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}], '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': 'D010859', 'term': 'Pigmentation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010038', 'term': 'azelaic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wedoderm@yahoo.com', 'phone': '502-451-9000', 'title': 'Leon Kircik, M.D.', 'organization': 'DermResearch, PLLC'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This is an open-label study with a small number of subjects.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Finacea', 'description': 'Open label pilot study', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid 15% Open Label', 'description': 'Assessments of IGA'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 16 weeks', 'description': 'IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acis 15% Open Label', 'description': 'Assessments of PIH IGA'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to16 weeks', 'description': 'IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid 15%'}], 'classes': [{'title': '2 grade improvement', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': '1 grade improvement', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 16 weeks', 'description': 'The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Total Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid 15%', 'description': 'lesion counts'}], 'classes': [{'categories': [{'measurements': [{'value': '-92.4', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).', 'unitOfMeasure': 'percentage of total lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Tolerability Assessments as Measured by the Number of Participants With Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid 15%', 'description': 'tolerability assessments'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Finacea', 'description': 'Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Subjects recruited from private office population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Finacea', 'description': 'Open label pilot study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '10.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-24', 'studyFirstSubmitDate': '2009-12-23', 'resultsFirstSubmitDate': '2012-03-26', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-24', 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)', 'timeFrame': 'Baseline to 16 weeks', 'description': 'IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)', 'timeFrame': 'Baseline to16 weeks', 'description': 'IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement'}, {'measure': 'Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution', 'timeFrame': 'Baseline to 16 weeks', 'description': 'The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%'}, {'measure': 'Percentage Change in Total Lesion Counts', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).'}, {'measure': 'Tolerability Assessments as Measured by the Number of Participants With Side Effects', 'timeFrame': '16 weeks', 'description': 'Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris', 'Post Inflammatory Hyperpigmentation']}, 'descriptionModule': {'briefSummary': 'Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, at least 12 years of age\n* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline\n* Fitzpatrick skin type IV to VI\n* Acne IGA (Investigator Global Assessment) score of 2 or 3\n* Inflammatory lesions of 15-60 (with no more than 2 nodules)\n* Non-inflammatory lesions of 20-100\n* Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of 3,4 or 5\n* Able to understand the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must have the written informed consent of a parent or legal guardian\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control\n* Allergy or sensitivity to any component of the test medication\n* Subjects who have not complied with the wash out periods for prohibited medications\n* Medical condition that contraindicates participation\n* Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH\n* Evidence of recent alcohol or drug abuse\n* History of poor cooperation, non-compliance or unreliability\n* Exposure to an investigational drug study within 30 day of Baseline visit'}, 'identificationModule': {'nctId': 'NCT01038869', 'briefTitle': 'Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)', 'organization': {'class': 'OTHER', 'fullName': 'Derm Research, PLLC'}, 'officialTitle': 'Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris', 'orgStudyIdInfo': {'id': 'FIN0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azelaic acid 15% (Finacea)', 'description': 'Open label pilot study, Topical gel to be appiled twice daily for 16 weeks', 'interventionNames': ['Drug: Azelaic acid']}], 'interventions': [{'name': 'Azelaic acid', 'type': 'DRUG', 'otherNames': ['Finacea'], 'description': 'Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.', 'armGroupLabels': ['Azelaic acid 15% (Finacea)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'DermResearch, PLLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Leon H. Kircik, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DermResearch, PLLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derm Research, PLLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leon Kircik, M.D.', 'investigatorAffiliation': 'Derm Research, PLLC'}}}}