Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-04-09 @ 4:04 PM
Study NCT ID:
NCT01111994
Status:
UNKNOWN
Last Update Posted:
2010-05-20
First Post:
2010-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy & Safety of Clindamycin and Tretinoin in Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C007084', 'term': 'clindamycin phosphate'}, {'id': 'D014212', 'term': 'Tretinoin'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-19', 'studyFirstSubmitDate': '2010-04-26', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of acne and post inflammatory hyperpigmentation', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperpigmentation'], 'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is ascertain the efficacy and safety of Clindamycin\n\nPhosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post\n\nInflammatory Hyperpigmentation in patients with skin of color.', 'detailedDescription': 'Acne is a chronic disorder of the pilosebaceous glands characterized by\n\ninflammatory papules, pustules, opened and closed comedones, cysts and\n\nnodules. Post inflammatory hyperpigmentation is a condition in which an\n\ninflammation from a disease such as acne, trauma, or abrasion results in areas\n\nof the skin with increased melanin content compared to the surrounding skin.\n\nThere are several treatments available for acne, which include benzoyl\n\nperoxide,antibiotics (topical or oral), and topical retinoids (tretinoin,\n\ntazarotene, adapalene). Combination therapy, such as topical retinoid and\n\nclindamycin, has been shown to be more effective than monotherapy in\n\naddressing all pathogenic factors of acne.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation\n* Photo skin types IV - VI\n* Ages 12 and older\n* Both sexes\n* Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products\n* Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives\n\nExclusion Criteria:\n\n* Seborrheic dermatitis\n* PIH of solely dermal origin\n* Acne vulfaris known to be resistant to oral antibiotics\n* Use of erythromycin-containing products\n* Use of neuromuscular blocking agents\n* Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).'}, 'identificationModule': {'nctId': 'NCT01111994', 'briefTitle': 'Efficacy & Safety of Clindamycin and Tretinoin in Acne', 'organization': {'class': 'OTHER', 'fullName': 'Callender Center for Clinical Research'}, 'officialTitle': 'Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color', 'orgStudyIdInfo': {'id': 'VDC2009Z'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel', 'type': 'DRUG', 'otherNames': ['Ziana Gel'], 'description': 'Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20721', 'city': 'Mitchellville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Callender Center for Clinical Research', 'geoPoint': {'lat': 38.92, 'lon': -76.808}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Society Hill Dermatology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Valerie Callender, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Callender Center for Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Callender Center for Clinical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society Hill Dermatology', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Valerie D. Callender, M.D.', 'oldOrganization': 'Callender Center for Clinical Research'}}}}