Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 4:37 PM
Study NCT ID:
NCT05582434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2022-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experience With Topical Acne Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C007084', 'term': 'clindamycin phosphate'}, {'id': 'D000068816', 'term': 'Adapalene'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D002981', 'term': 'Clindamycin'}], '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': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': 'End of study visit - day 56', 'description': 'Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached'}, {'measure': 'Medication Adherence', 'timeFrame': 'End of study visit - day 56', 'description': 'Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened'}], 'secondaryOutcomes': [{'measure': 'Gender specific adherence (female subjects)', 'timeFrame': 'End of study visit - day 56', 'description': 'Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome'}, {'measure': 'Gender specific adherence (male subjects)', 'timeFrame': 'End of study visit - day 56', 'description': 'Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne']}, 'referencesModule': {'references': [{'pmid': '20618564', 'type': 'BACKGROUND', 'citation': "Lott R, Taylor SL, O'Neill JL, Krowchuk DP, Feldman SR. Medication adherence among acne patients: a review. J Cosmet Dermatol. 2010 Jun;9(2):160-6. doi: 10.1111/j.1473-2165.2010.00490.x."}, {'pmid': '27784999', 'type': 'BACKGROUND', 'citation': 'Moradi Tuchayi S, Alexander TM, Nadkarni A, Feldman SR. Interventions to increase adherence to acne treatment. Patient Prefer Adherence. 2016 Oct 11;10:2091-2096. doi: 10.2147/PPA.S117437. eCollection 2016.'}, {'pmid': '23572294', 'type': 'BACKGROUND', 'citation': 'Tan X, Al-Dabagh A, Davis SA, Lin HC, Balkrishnan R, Chang J, Feldman SR. Medication adherence, healthcare costs and utilization associated with acne drugs in Medicaid enrollees with acne vulgaris. Am J Clin Dermatol. 2013 Jun;14(3):243-51. doi: 10.1007/s40257-013-0016-x.'}]}, 'descriptionModule': {'briefSummary': 'Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients ≥18 years of age\n2. Patients with a current diagnosis of acne\n3. Patients who live in the US,\n4. Patients have sufficient command of the English language\n\nExclusion Criteria:\n\n1. Patients less than the age of 18\n2. Patients without a current diagnosis of acne\n3. Patients who do not live in the US\n4. Patients without a sufficient command of the English language'}, 'identificationModule': {'nctId': 'NCT05582434', 'briefTitle': 'Experience With Topical Acne Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications', 'orgStudyIdInfo': {'id': 'IRB00089304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One single fixed-combination product', 'description': 'Participants instructed to apply clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel once daily', 'interventionNames': ['Drug: clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel']}, {'type': 'EXPERIMENTAL', 'label': 'Two products', 'description': 'Participants instructed to apply 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel once daily', 'interventionNames': ['Drug: adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel']}, {'type': 'EXPERIMENTAL', 'label': 'Three products', 'description': 'Participants instructed to apply BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel once daily', 'interventionNames': ['Drug: Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel']}], 'interventions': [{'name': 'clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel', 'type': 'DRUG', 'otherNames': ['Cabtreo®'], 'description': 'Single topical treatment to be applied daily to area affected once daily.', 'armGroupLabels': ['One single fixed-combination product']}, {'name': 'adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel', 'type': 'DRUG', 'otherNames': ['Epiduo® Forte and Clindamycin'], 'description': 'Two topical treatments to be applied to area affected once daily.', 'armGroupLabels': ['Two products']}, {'name': 'Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel', 'type': 'DRUG', 'otherNames': ['Differin®, Epsolay, Clindamycin'], 'description': 'Three topical treatments to be applied to area affected once daily.', 'armGroupLabels': ['Three products']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Steven R Feldman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}