Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:16 AM
Study NCT ID:
NCT07473895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D013148', 'term': 'Spironolactone'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D000068816', 'term': 'Adapalene'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'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': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label study in which both participants and investigators are aware of the treatment applied to each side of the face due to differences in formulation and application instructions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants with acne vulgaris will be enrolled in a split-face comparative study. Each participant will apply topical 5% spironolactone nano-formulation gel to one side of the face and topical 0.1% adapalene gel to the opposite side. This design allows each participant to serve as their own control and enables direct comparison of treatment efficacy and safety between the two topical therapies.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the Change in Acne Severity via Global Acne Grading System (GAGS)', 'timeFrame': 'Baseline and 8 weeks (end of treatment)', 'description': 'The GAGS is used to calculate acne severity separately for each half of the face. The face is divided into regions (forehead, cheeks, nose, chin) with assigned area factors. Each region is graded from 0 (no lesion) to 4 (nodule); the regional score is the product of the most severe lesion grade and the area factor'}], 'secondaryOutcomes': [{'measure': 'Measure Comparative Change in Global Acne Grading System (GAGS) Score', 'timeFrame': '8 weeks', 'description': 'The difference in acne severity between the two treated sides of the face will be evaluated using the Global Acne Grading System (GAGS). The GAGS assesses acne severity by evaluating six anatomical locations (forehead, right cheek, left cheek, nose, chin, and chest/upper back). Each location is assigned a factor based on surface area and lesion type (comedones, papules, pustules, and nodules).\n\nThe total score ranges from 0 to 44, where higher scores indicate more severe acne. The study will compare the reduction in GAGS scores between the facial side treated with topical 5% spironolactone nano-formulation gel and the side treated with topical 0.1% adapalene gel.'}, {'measure': 'Measure The Reduction in Total Lesion Count (TLC)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Sum of both inflammatory (papules, pustules) and non-inflammatory (open and closed comedones) lesions on each side of the face.'}, {'measure': 'Measure Change in Quality of Life Using the Cardiff Acne Disability Index (CADI)', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'Quality of life will be assessed using the Cardiff Acne Disability Index (CADI), a validated patient-reported questionnaire designed to measure the psychological and social impact of acne. The CADI consists of 5 questions, each scored from 0 to 3, resulting in a total score ranging from 0 to 15.\n\nHigher scores indicate greater impairment in quality of life related to acne. The Arabic validated version of the CADI will be used in this study. Changes in CADI scores will be assessed from baseline to 8 weeks of treatment.'}, {'measure': 'Measure Patient Treatment Satisfaction Assessed by the Dermatology Treatment Satisfaction Questionnaire (DermSat-7)', 'timeFrame': '8 weeks', 'description': 'Patient satisfaction with treatment will be assessed using the Dermatology Treatment Satisfaction Questionnaire (DermSat-7). This patient-reported instrument contains 7 items evaluating treatment effectiveness, convenience, tolerability, and overall satisfaction.\n\nEach item is rated on a 5-point Likert scale, resulting in a total score range from 7 to 35. Higher scores indicate greater treatment satisfaction. Scores will be evaluated at the end of the treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne vulgaris', 'Spironolactone', 'Adapalene', 'Topical therapy', 'Split-face study', 'Antiandrogen thearapy', 'Nano-Formulation', 'Dermatology', 'Acne treatment'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Charakida A, Charakida M, Chu AC. Double-blind, randomized, placebo-controlled study of a lotion containing triethyl citrate and ethyl linoleate in the treatment of acne vulgaris. Br J Dermatol. 2007;157(3):569-574. DOI: 10.1111/j.1365-2133.2007.08083.x.'}, {'type': 'BACKGROUND', 'citation': 'Elradi M, Hamed DE, Eltwansy MS, Hosny D. The impact of acne on quality of life: A cross-sectional study from Egypt. Skin Appendage Disord. 2025;11(3):255-261. DOI: 10.1159/000543051.'}, {'type': 'BACKGROUND', 'citation': 'Bae IH, Kwak JH, Na CH, et al. A comprehensive review of the acne grading scale in 2023. Ann Dermatol. 2024;36(2):65-73. DOI: 10.5021/ad.23.094.'}, {'type': 'BACKGROUND', 'citation': 'Shields A, Armstrong AW, Kaur MN, et al. Evaluation of DermSat-7 for assessing treatment satisfaction in patients with acne. JAMA Dermatol. 2024;160(1):88-92. DOI: 10.1001/jamadermatol.2023.4481.'}, {'type': 'BACKGROUND', 'citation': 'Althwanay A, AlEdani EM, Kaur H, et al. Efficacy of Topical Treatments in the Management of Mild-to-Moderate Acne Vulgaris: A Systematic Review. Cureus. 2024;16(4).'}, {'type': 'BACKGROUND', 'citation': 'Dereiah S, Ghori MU, Conway BR. A systematic review of spironolactone nano-formulations for topical treatment of skin hyperandrogenic disorders and chronic wounds. Pharmaceutics. 2024;17(1):27. DOI: 10.3390/pharmaceutics17010027.'}, {'type': 'BACKGROUND', 'citation': 'Zhu Z, Zhong X, Luo Z, et al. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10-24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025;192(2):228-237.'}], 'seeAlsoLinks': [{'url': 'http://www.emro.who.int/unified-medical-dictionary.html', 'label': 'WHO Unified Medical Dictionary used for Arabic terminology in the study.'}]}, 'descriptionModule': {'briefSummary': 'Acne vulgaris is one of the most common dermatological conditions affecting adolescents and young adults. It results from multiple pathogenic factors, including increased sebum production, follicular hyperkeratinization, colonization by Cutibacterium acnes, and inflammation. Topical retinoids such as adapalene are widely used as first-line therapy; however, they may cause irritation and are not always effective in all patients. Recently, topical antiandrogen therapies such as spironolactone have gained attention because of their ability to reduce sebum production and improve acne lesions.\n\nThis study aims to evaluate the efficacy and safety of a topical 5% spironolactone gel nano-formulation compared with 0.1% adapalene gel in the treatment of acne vulgaris. A split-face study design will be used in which each participant will receive spironolactone gel on one side of the face and adapalene gel on the other side. This design allows each participant to serve as their own control and helps reduce variability in treatment response.\n\nParticipants diagnosed with acne vulgaris will be enrolled and treated for a defined follow-up period. Clinical assessment will be performed at baseline and during scheduled follow-up visits to evaluate improvement in acne lesions and monitor possible adverse effects. The primary outcomes will include changes in acne lesion counts and clinical severity scores. Safety and tolerability of both treatments will also be assessed.\n\nThe results of this study may provide evidence regarding the effectiveness of topical spironolactone nano-formulation as a potential alternative or adjunct therapy for acne vulgaris.', 'detailedDescription': 'Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit that affects a large proportion of adolescents and young adults worldwide. The condition is characterized by the development of comedones, papules, pustules, and in severe cases nodules and cysts. The pathogenesis of acne involves multiple mechanisms including follicular hyperkeratinization, excessive sebum production stimulated by androgens, colonization with Cutibacterium acnes, and inflammatory responses within the pilosebaceous unit.\n\nTopical retinoids are considered a cornerstone in the management of acne vulgaris due to their comedolytic and anti-inflammatory properties. Adapalene, a third-generation topical retinoid, is commonly used because of its efficacy and relatively favorable tolerability profile. Despite these advantages, some patients experience skin irritation, dryness, and erythema, which may limit adherence and treatment outcomes.\n\nSpironolactone is an antiandrogen medication traditionally used orally for the treatment of hormonal acne, particularly in females. It acts by blocking androgen receptors and reducing sebaceous gland activity, thereby decreasing sebum production. However, systemic administration may be associated with potential adverse effects. Topical formulations of spironolactone have been proposed as an alternative approach to deliver antiandrogen effects locally while minimizing systemic exposure.\n\nRecent advances in pharmaceutical technology, including nano-formulation delivery systems, may enhance the penetration and stability of topical medications and improve therapeutic outcomes. A topical 5% spironolactone gel nano-formulation may provide improved skin penetration and targeted delivery to the pilosebaceous unit.\n\nThe present study is designed as a split-face comparative clinical study to evaluate the efficacy and safety of topical 5% spironolactone gel nano-formulation compared with topical 0.1% adapalene gel in patients with acne vulgaris. In this design, each participant will apply spironolactone gel to one side of the face and adapalene gel to the other side according to the study protocol. This approach allows direct comparison of the two treatments within the same individual and minimizes inter-individual variability.\n\nEligible participants diagnosed with acne vulgaris will be recruited from dermatology clinics. Baseline clinical assessment will include evaluation of acne severity, lesion counts, and skin examination. Participants will receive instructions regarding the application of each topical treatment and follow-up visits will be scheduled throughout the study period to monitor treatment response and detect possible adverse events.\n\nThe primary outcome will be the change in acne lesion counts and clinical severity after the treatment period. Secondary outcomes will include evaluation of treatment tolerability, improvement in inflammatory and non-inflammatory lesions, and documentation of local adverse reactions such as erythema, dryness, burning sensation, or irritation.\n\nThe findings of this study may contribute to the growing body of evidence regarding topical antiandrogen therapy for acne and may support the use of spironolactone nano-formulation as an effective and safe topical treatment option for patients with acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: 18-45 years old.\n\n* Patients with mild to moderate bilateral acne vulgaris on the face.\n* Presence of non-inflammatory acne (open and closed comedones).\n* Presence of inflammatory papules and pustules.\n\nExclusion Criteria:\n\n* Pregnancy and lactation.\n* Patients taking oral contraceptive pills or any hormonal treatment.\n* Patients who were using topical or systemic medications for acne in the last two months prior to starting therapy.\n* Patients who had received laser resurfacing, chemical peeling, mesotherapy, or any similar facial interventions.'}, 'identificationModule': {'nctId': 'NCT07473895', 'briefTitle': 'Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face Study', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Efficacy and Safety of Topical 5% Spironolactone Gel Nano-Formulation Versus 0.1% Adapalene Gel in the Management of Acne Vulgaris: A Split-Face Study', 'orgStudyIdInfo': {'id': 'AUN-DERM-ACNE-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical 5% Spironolactone Gel nano-formulation.', 'description': 'Participants will apply topical 5% spironolactone nano-formulation gel to one side of the face once daily during the study period to evaluate its efficacy and safety in the treatment of acne vulgaris.', 'interventionNames': ['Drug: Spironolactone 5% Topical Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical 0.1% Adapalene Gel', 'description': 'Participants will apply topical 0.1% adapalene gel to the opposite side of the face once daily during the study period for comparison of efficacy and safety.', 'interventionNames': ['Drug: Adapalene 0.1% Topical Gel']}], 'interventions': [{'name': 'Spironolactone 5% Topical Gel', 'type': 'DRUG', 'otherNames': ['Topical Spironolactone', 'Spironolactone Nano-Gel', 'Spironolactone 5% Gel'], 'description': 'This is a drug-loaded nanospanlastics dispersion (using Span 60 and Tween 40) fabricated via the ethanol injection technique. It is applied twice daily to one half of the face for 8 weeks.', 'armGroupLabels': ['Topical 5% Spironolactone Gel nano-formulation.']}, {'name': 'Adapalene 0.1% Topical Gel', 'type': 'DRUG', 'otherNames': ['Topical Adapalene', 'Adapalene Gel', 'Adapalene 0.1%'], 'description': 'A third-generation retinoid applied once daily at night to the opposite half of the face.', 'armGroupLabels': ['Topical 0.1% Adapalene Gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Assiut University', 'role': 'CONTACT', 'email': 'vp_grad@aun.edu.eg', 'phone': '08822080150'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mai Ahmed Ahmed', 'role': 'CONTACT', 'email': 'Mai1998530@gmail.com', 'phone': '01123095269'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at dermatology, venereology and andrology department', 'investigatorFullName': 'Mai Ahmed Thabet Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}