Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 9:10 PM
Study NCT ID:
NCT07421804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Topical Dutasteride as a Potential New Therapy for Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)
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': 'D000068538', 'term': 'Dutasteride'}], 'ancestors': [{'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV', 'timeFrame': '16 weeks', 'description': 'o Total lesions count (TLC) (inflammatory lesions and noninflammatory lesions)'}, {'measure': 'Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV', 'timeFrame': '12 weeks', 'description': "o The investigator's global assessment (IGA) of acne severity grade modified to assess the half-face acne severity ; Treatment success will be defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline at week 12."}], 'secondaryOutcomes': [{'measure': 'Addressing the safety profile of the two topical therapeutics', 'timeFrame': '12 weeks', 'description': 'By recording side effects by daily diary specifying side effect (whether systemic or topical ,type,site and onset )'}, {'measure': 'Psychological effect of AV and its relation to therapeutic outcomes', 'timeFrame': '12 weeks', 'description': 'Cardiff Acne Disability Index (CADI) will be assessed at first visit and at end of 12 week-study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '26689434', 'type': 'BACKGROUND', 'citation': 'Voutilainen A, Pitkaaho T, Kvist T, Vehvilainen-Julkunen K. How to ask about patient satisfaction? The visual analogue scale is less vulnerable to confounding factors and ceiling effect than a symmetric Likert scale. J Adv Nurs. 2016 Apr;72(4):946-57. doi: 10.1111/jan.12875. Epub 2015 Dec 22.'}, {'pmid': '32478930', 'type': 'BACKGROUND', 'citation': 'El-Husseiny R, Elframawy S, Abdallah M. Comparative study between fractional carbon dioxide laser vs intralesional steroid injection in treatment of alopecia areata. Dermatol Ther. 2020 Jul;33(4):e13742. doi: 10.1111/dth.13742. Epub 2020 Jul 9.'}, {'pmid': '40140055', 'type': 'BACKGROUND', 'citation': 'Boonpethkaew S, Ratanapokasatit Y, Chirasuthat S, Wattanakrai P. Efficacy and safety of the 589/1319 nm solid-state dual-wavelength laser combined with topical benzoyl peroxide for inflammatory acne vulgaris: a split-face randomized controlled trial. Arch Dermatol Res. 2025 Mar 26;317(1):635. doi: 10.1007/s00403-025-04146-6.'}, {'pmid': '17635508', '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 Sep;157(3):569-74. doi: 10.1111/j.1365-2133.2007.08083.x. Epub 2007 Jul 16.'}, {'pmid': '40475110', '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 Jun;11(3):255-261. doi: 10.1159/000543051. Epub 2024 Dec 10.'}, {'pmid': '39343753', 'type': 'BACKGROUND', 'citation': 'Kim KY, Song SY, Jung YJ, Jue MS, Hong JY, Kim BJ, Ko JY. A Randomized, Split-Face, Comparative Study of a Combined Needle Radiofrequency/Intense Pulsed Light Device in Moderate-to-Severe Acne Patients. Ann Dermatol. 2024 Oct;36(5):266-274. doi: 10.5021/ad.23.083.'}, {'pmid': '38791344', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Kim YH. Exploring Acne Treatments: From Pathophysiological Mechanisms to Emerging Therapies. Int J Mol Sci. 2024 May 13;25(10):5302. doi: 10.3390/ijms25105302.'}, {'pmid': '23905540', 'type': 'BACKGROUND', 'citation': 'Beylot C, Auffret N, Poli F, Claudel JP, Leccia MT, Del Giudice P, Dreno B. Propionibacterium acnes: an update on its role in the pathogenesis of acne. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):271-8. doi: 10.1111/jdv.12224. Epub 2013 Aug 1.'}, {'pmid': '39749123', 'type': 'BACKGROUND', 'citation': 'Almudimeegh A, AlMutairi H, AlTassan F, AlQuraishi Y, Nagshabandi KN. Comparison between dutasteride and finasteride in hair regrowth and reversal of miniaturization in male and female androgenetic alopecia: a systematic review. Dermatol Reports. 2024 Apr 12;16(4):9909. doi: 10.4081/dr.2024.9909. eCollection 2024 Nov 21.'}, {'pmid': '14988688', 'type': 'BACKGROUND', 'citation': 'Leyden J, Bergfeld W, Drake L, Dunlap F, Goldman MP, Gottlieb AB, Heffernan MP, Hickman JG, Hordinsky M, Jarrett M, Kang S, Lucky A, Peck G, Phillips T, Rapaport M, Roberts J, Savin R, Sawaya ME, Shalita A, Shavin J, Shaw JC, Stein L, Stewart D, Strauss J, Swinehart J, Swinyer L, Thiboutot D, Washenik K, Weinstein G, Whiting D, Pappas F, Sanchez M, Terranella L, Waldstreicher J. A systemic type I 5 alpha-reductase inhibitor is ineffective in the treatment of acne vulgaris. J Am Acad Dermatol. 2004 Mar;50(3):443-7. doi: 10.1016/j.jaad.2003.07.021.'}, {'pmid': '40909044', 'type': 'BACKGROUND', 'citation': 'Panuganti VK, Kumar Madala P, Ramalingayya Grandhi V, Varma Alluri C, Mohammad J, Rao Kssvv S, Reddy Dundigalla M. A Randomized, Double-Blind, Placebo and Active Controlled Phase II Study to Evaluate the Safety and Efficacy of Novel Dutasteride Topical Solution (0.01%, 0.02%, and 0.05% w/v) in Male Subjects With Androgenetic Alopecia. Cureus. 2025 Aug 3;17(8):e89309. doi: 10.7759/cureus.89309. eCollection 2025 Aug.'}, {'pmid': '38192024', 'type': 'BACKGROUND', 'citation': 'Del Rosso JQ, Kircik L. The cutaneous effects of androgens and androgen-mediated sebum production and their pathophysiologic and therapeutic importance in acne vulgaris. J Dermatolog Treat. 2024 Dec;35(1):2298878. doi: 10.1080/09546634.2023.2298878. Epub 2024 Jan 8.'}, {'pmid': '39433524', 'type': 'BACKGROUND', 'citation': 'Gupta AK, Mann A, Vincent K, Abramovits W. CABTREOTM (Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide) Topical Gel. Skinmed. 2024 Oct 22;22(5):375-378. eCollection 2024.'}, {'pmid': '34674160', 'type': 'BACKGROUND', 'citation': 'Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21.'}, {'pmid': '38300170', 'type': 'BACKGROUND', 'citation': 'Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30.'}, {'pmid': '29083670', 'type': 'BACKGROUND', 'citation': 'Sutaria AH, Masood S, Saleh HM, Schlessinger J. Acne Vulgaris. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459173/'}]}, 'descriptionModule': {'briefSummary': 'Acne vulgaris (AV) is one of the most prevalent dermatological conditions worldwide, affecting approximately 85% of adolescents and young adults between the ages of 12 and 24 years .While acne is often self-limiting, it can have profound psychosocial implications as individuals with acne are more likely to experience emotional distress, lower self-esteem and anxiety disorders .\n\nAcne Vulgaris is a chronic inflammatory skin condition affecting the pilosebaceous units that leads to the development of different skin lesions such as comedones, papules, pustules, nodules and cystic lesions .', 'detailedDescription': "The pathogenesis of AV involves the interaction of several host factors, including the stimulation of sebaceous glands by circulating androgens, follicular occlusion, dysbiosis of the pilosebaceous unit, and cellular immune/inflammatory responses .\n\nDespite the availability of a wide range of treatment modalities, acne management remains challenging due to factors such as antibiotic resistance, patient adherence issues, and the varying response to treatments based on individual skin types . However, recent advances in understanding the pathogenesis of acne and developing novel therapeutic modalities have reshaped the landscape of its management .\n\nTopical treatments remain the cornerstone of initial acne therapy and are favored over systemic options due to their lower risk of adverse effects and suitability for prolonged use. However, increasing concerns over antibiotic resistance and suboptimal outcomes have led to the exploration of alternative topical therapies .\n\nThe American Academy of Dermatology guidelines recommend a multimodal approach to therapy incorporating agents with multiple mechanisms of action to address the multifactorial pathogenesis of acne .Thus, combining treatments in an easy-to-use, fixed-dose formulation can improve treatment adherence by reducing complex drug regimens hence improve efficacy .\n\nAdapalene is a third-generation retinoid that modulates cellular keratinization, differentiation, and proliferation . Furthermore, it is one of the most tolerable retinoids that retains its stability in the presence of Benzoyl peroxide (BPO).\n\nBenzoyl peroxide is an antibacterial agent with mild comedolytic activity, keratolytic effects, and good efficacy and tolerability . It is unaffected by Cutibacterium acnes (C. acnes) resistance and has been used in combination with topical and oral antibiotics because of its ability to reduce resistant C. acnes populations .\n\nMoreover, topical and oral antibiotics reduce C. acnes colonization and proliferation . Clindamycin is a widely researched and commonly prescribed antibiotic with anti-inflammatory effects that has been used for acne treatment for over 30 years . Adding clindamycin to BPO not only increases antibiotic activity , but also lessens irritation .\n\nAltogether, the combination of these three acne treatments targets three of the four acne pathogenic pathways and may reduce the antibiotic resistance and adverse cutaneous effects observed with .Thus, CabtreoTM (1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide) topical gel was approved by the US Food and Drug Administration (FDA) in October 2023 for the treatment of moderate to severe acne vulgaris in patients aged ≥12 years .\n\nThe pathophysiology of acne is profoundly influenced by hormonal factors, particularly those that alter sebaceous gland function. Androgen hormones play a key role in acne development, with acne prevalence reaching up to 96.0% during adolescence because of changes in androgen levels during puberty . They drive acne development by altering the pilosebaceous unit, resulting in increased sebum production, keratinocyte proliferation, and inflammation .\n\nSebum secretion by the sebaceous glands is accelerated by the conversion of testosterone to 5α dihydrotestosterone (DHT) by type I 5α-reductase (5AR), which is strongly expressed in the sebaceous glands. Therefore, it has been proposed that type I 5AR inhibitors have the potential to improve AV .\n\nDutasteride inhibits both type I and type II 5α-reductase enzymes. It is approximately 100 times and 3 times more potent than finasteride to inhibit the type I and II 5α-reductase isoenzymes, respectively. Moreover, Dutasteride can also decrease serum DHT by \\>90%, being more effective than finasteride at reducing DHT levels .\n\nOral dutasteride is FDA approved for benign prostatic hyperplasia in men and is used off-label for androgenetic alopecia in both men and women .The oral formulation of dutasteride is associated with fewer side effects than finasteride but there is still elevated incidence of side effects such as sexual dysfunction ,decreased libido ,erectile dysfunction and depression .However, the topical formulation would have negligible systemic absorption, resulting in minimal systemic side effects and better drug availability at the site of action thereby offering better efficacy without any safety concerns .\n\nDutasteride topical solution has been previously used for treating male baldness with different concentrations. The 0.05% concentration demonstrated better efficacy than finasteride (1 mg/day). Moreover, topical dutasteride was well-tolerated, with minimal dermal irritation and no significant adverse events or withdrawals, thereby confirming its favorable safety profile.\n\nThe skin microbiome plays a role in maintaining skin health by balancing homeostatic relationships. Recent studies of AV have highlighted the role of the skin microbiome, shifting focus from individual pathogens to microbial community dynamics .\n\nWhile the proliferation of C. acnes has been associated with acne, it is the diversity and specific phylotypes of C. acnes that are more directly implicated in acne development . Different strains of C. acnes can induce varying immune responses. Acne-associated strains trigger pro-inflammatory cytokines like interferon (IFN)-γ and interleukin (IL)-17, whereas health-associated strains promote the production of the anti-inflammatory IL-10 .\n\nCutibacterium acnes plays a pivotal role in acne pathogenesis by interacting with innate immunity through the release of extracellular enzymes and reactive oxygen species and the activation of Toll like receptors, alongside influencing sebum production, keratin, filaggrin, and insulin growth factor-1 levels. This leads to inflammation and hyperkeratosis, which maintains inflammation through acquired cell-mediated responses via T- helper 1 cells .\n\nBacterial biofilms are heterogeneous structures consisting of aggregates of bacterial populations embedded in a matrix that constitutes a reservoir of bacteria. The pathogenic role of biofilms is now well established in the development and exacerbation of chronic inflammatory skin diseases such as acne. The intricate composition of the biofilm protects bacteria from antibiotics and the immune system's activity. Thus, it is challenging to eradicate a bacterial biofilm once set .\n\nCurrent research about acne treatment explores various facets, including sebaceous gland activity, inflammation, microbial flora and biofilm, and even systemic influences like diet, unveiling promising candidates, each targeting different aspects of acne's multifactorial nature ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with facial acne vulgaris older than 18 years.\n\nExclusion Criteria:\n\n* · Unrealistic expectations.\n\n * Unable to follow up.\n * Severe and nodulocystic AV.\n * Patients on topical treatment for AV (4 weeks before enrollment) and on systemic treatment for AV (3 months before enrollment).\n * Patients on any systemic medication 3 months before enrollment.\n * Suspicion of malignancy, including prostate cancer\n * History of infertility or difficulty in fathering children.\n * Pregnancy \\& lactation.\n * Planning to become pregnant during study period or 6 months after ending treatment\n * Patients with any concomitant dermatologic or systemic illness.'}, 'identificationModule': {'nctId': 'NCT07421804', 'briefTitle': 'Evaluation of Topical Dutasteride as a Potential New Therapy for Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical and Microbiological Evaluation of Topical Dutasteride as a Potential New Therapy of Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)', 'orgStudyIdInfo': {'id': 'Topical dutasteride in AV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face).', 'interventionNames': ['Drug: topical dutasteride']}, {'type': 'EXPERIMENTAL', 'label': 'Topical Dutasteride 0.05% gel versus topical triple fixed-dose combination', 'interventionNames': ['Drug: topical dutasteride']}], 'interventions': [{'name': 'topical dutasteride', 'type': 'DRUG', 'otherNames': ['Dutasteride', 'Triple fixed combination'], 'description': '* Group I will be treated by topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face).\n* Group II will be treated by topical Dutasteride 0.05% gel versus topical triple fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel (split face).', 'armGroupLabels': ['Topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face).', 'Topical Dutasteride 0.05% gel versus topical triple fixed-dose combination']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ola A Elminshawy, M.Sc.', 'role': 'CONTACT', 'email': 'ola-elminshawy@aun.edu.eg', 'phone': '+201112693230'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ola Ahmed Elminshawy', 'investigatorAffiliation': 'Assiut University'}}}}