{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T02:38:04Z","timestamp":1770777484506,"version":"3.50.0"},"reference-count":26,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T00:00:00Z","timestamp":1695081600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Glenmark Pharmaceuticals Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antibiotics"],"abstract":"<jats:p>Acne vulgaris is characterized by inflammatory and non-inflammatory skin lesions with a high prevalence among adolescents in India. Not enough studies are reported on the use of topical antibiotics for the management of acne in the Indian population. The proposed study aims to compare the efficacy and safety of topical minocycline gel 4% with topical clindamycin gel 1% in the Indian population. A randomized, open-label, double-arm study was planned at two centers in India. One hundred patients were enrolled and randomized equally to two treatment arms. The drugs were applied once daily, preferably at the same time each day. The number of inflammatory and non-inflammatory lesions, as well as the investigator\u2019s global assessment (IGA), were obtained at the baseline and on weeks 3, 6, 9, and 12. The change in these parameters from baseline to week 12 was compared between the two treatment arms. A tolerability assessment was also performed on selected parameters. The age of patients ranged between 14 and 31 years, with female preponderance in each arm. On week 12, the percent change in inflammatory and non-inflammatory lesions in the minocycline 4% arm was significantly higher than in the clindamycin 1% arm (p &lt; 0.0001). The IGA treatment success was significantly higher in the minocycline arm compared to the clindamycin arm on weeks 9 and 12, with p-values of 0.001 and 0.015, respectively. Tolerability assessment revealed significantly improved parameter performance in the minocycline arm compared to the clindamycin arm. On subgroup analysis, in adolescents, minocycline was found to be more efficacious than clindamycin. The comparative assessment resulted in a significantly improved performance of minocycline gel 4% compared to clindamycin gel 1% in the Indian population, thus making it a preferred choice for the treatment of moderate-to-severe acne in India.<\/jats:p>","DOI":"10.3390\/antibiotics12091455","type":"journal-article","created":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T02:26:17Z","timestamp":1695090377000},"page":"1455","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris"],"prefix":"10.3390","volume":"12","author":[{"given":"Bela","family":"Shah","sequence":"first","affiliation":[{"name":"Department of Dermatology, B J Medical College, Civil Hospital, Ahmedabad 380016, Gujarat, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deval","family":"Mistry","sequence":"additional","affiliation":[{"name":"Consultant Dermatologist, Mistry Skin Clinic, Ahmedabad 301302, Gujarat, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nelry","family":"Gonsalves","sequence":"additional","affiliation":[{"name":"Department of Dermatology, B J Medical College, Civil Hospital, Ahmedabad 380016, Gujarat, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Presha","family":"Vasani","sequence":"additional","affiliation":[{"name":"Department of Dermatology, B J Medical College, Civil Hospital, Ahmedabad 380016, Gujarat, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2045-9324","authenticated-orcid":false,"given":"Dhiraj","family":"Dhoot","sequence":"additional","affiliation":[{"name":"Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai 400099, Maharashtra, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanmant","family":"Barkate","sequence":"additional","affiliation":[{"name":"Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai 400099, Maharashtra, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,19]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"5754","DOI":"10.1038\/s41598-020-62715-3","article-title":"Systematic review of the epidemiology of acne vulgaris","volume":"10","author":"Heng","year":"2020","journal-title":"Sci. Rep."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1111\/bjd.20882","article-title":"Magnitude and temporal trend of acne vulgaris burden in 204 countries and territories from 1990 to 2019: An analysis from the Global Burden of Disease Study 2019","volume":"186","author":"Chen","year":"2022","journal-title":"Br. J. Dermatol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"237","DOI":"10.18231\/j.ijced.2020.048","article-title":"Acne in Indian population: An epidemiological study evaluating multiple factors","volume":"6","author":"Budamakuntla","year":"2020","journal-title":"IP Indian J. Clin. Exp. Dermatol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"41","DOI":"10.4161\/derm.3.1.13900","article-title":"An update on the role of the sebaceous gland in the pathogenesis of acne","volume":"3","author":"Makrantonaki","year":"2011","journal-title":"Derm.-Endocrinol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"397","DOI":"10.1007\/s00403-008-0879-5","article-title":"The sebocyte culture: A model to study the pathophysiology of the sebaceous gland in sebostasis, seborrhoea and acne","volume":"300","author":"Zouboulis","year":"2008","journal-title":"Arch Dermatol. Res."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"534","DOI":"10.2340\/00015555-70534537","article-title":"A double-blind comparison of topical clindamycin and oral minocycline in the treatment of acne vulgaris","volume":"70","author":"Cunliffe","year":"1990","journal-title":"Acta Derm. Venereol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1140","DOI":"10.3855\/jidc.6862","article-title":"In vitro antimicrobial susceptibility patterns of Propionibacterium acnes isolated from patients with acne vulgaris","volume":"10","author":"Biswal","year":"2016","journal-title":"J. Infect. Dev. Ctries"},{"key":"ref_8","first-page":"1022","article-title":"Pharmacokinetic comparison of once-daily topical minocycline foam 4% vs oral minocycline for moderate-to-severe acne","volume":"16","author":"Jones","year":"2017","journal-title":"J. Drugs Dermatol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1016\/j.jaad.2018.08.020","article-title":"A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies","volume":"80","author":"Gold","year":"2019","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1007\/s40257-020-00523-1","article-title":"Topical Minocycline Foam 4%: A Review in Acne Vulgaris","volume":"21","author":"Paik","year":"2020","journal-title":"Am. J. Clin. Dermatol."},{"key":"ref_11","first-page":"16","article-title":"Open-label extension study evaluating long-term safety and efficacy of FMX101 4% minocycline foam for moderate-to-severe acne vulgaris","volume":"12","author":"Gold","year":"2019","journal-title":"J. Clin. Aesthet. Dermatol."},{"key":"ref_12","unstructured":"(2023, June 30). Available online: https:\/\/cdsco.gov.in\/opencms\/resources\/UploadCDSCOWeb\/2018\/UploadCommitteeFiles\/54th%20%20Dermatology%20Recommendation%2012.01.2021.pdf."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.2147\/CCID.S323132","article-title":"The Anti-Acne Effect of Near-Infrared Low-Level Laser Therapy","volume":"14","author":"Budzisz","year":"2021","journal-title":"Clin. Cosmet. Investig. Dermatol."},{"key":"ref_14","first-page":"46","article-title":"Efficacy and tolerability of an acne treatment regimen with antiaging benefits in adult women","volume":"11","author":"Jiang","year":"2018","journal-title":"J. Clin. Aesthet. Dermatol."},{"key":"ref_15","unstructured":"World Health Organization (2023, June 30). Adolescent Health. Available online: https:\/\/www.who.int\/health-topics\/adolescent-health#tab=tab_1."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"688","DOI":"10.1111\/j.1365-4632.2011.05403.x","article-title":"Antimicrobial susceptibility of Propionibacterium acnes isolates from acne patients in Colombia","volume":"52","author":"Mendoza","year":"2013","journal-title":"Int. J. Dermatol."},{"key":"ref_17","first-page":"CD002086","article-title":"Minocycline for acne vulgaris: Efficacy and safety","volume":"2012","author":"Garner","year":"2012","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"832","DOI":"10.1016\/j.jaad.2019.05.078","article-title":"Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study","volume":"82","author":"Raoof","year":"2020","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_19","first-page":"14","article-title":"Formulation and Profile of FMX101 4% Minocycline Topical Foam for the Treatment of Acne Vulgaris","volume":"13","author":"Kircik","year":"2020","journal-title":"J. Clin. Aesthet. Dermatol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1177\/1060028020939926","article-title":"Minocycline Topical Foam: A New Drug for the Treatment of Acne","volume":"55","author":"Onge","year":"2021","journal-title":"Ann. Pharmacother."},{"key":"ref_21","first-page":"15","article-title":"A review of the anti-inflammatory properties of clindamycin in the treatment of acne vulgaris","volume":"85","author":"Schmidt","year":"2010","journal-title":"Cutis"},{"key":"ref_22","first-page":"YC05","article-title":"Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial","volume":"8","author":"Bhavsar","year":"2014","journal-title":"J. Clin. Diagn. Res."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"945","DOI":"10.1016\/j.jaad.2015.12.037","article-title":"Guidelines of care for the management of acne vulgaris","volume":"74","author":"Zaenglein","year":"2016","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1046\/j.1365-2133.2003.05067.x","article-title":"Antibiotic resistant acne: Lessons from Europe","volume":"148","author":"Ross","year":"2003","journal-title":"Br. J. Dermatol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1251","DOI":"10.1016\/j.jaad.2015.09.065","article-title":"Topical minocycline foam for moderate to severe acne vulgaris: Phase 2 randomized double-blind, vehicle-controlled study results","volume":"74","author":"Shemer","year":"2016","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1080\/09546634.2016.1214234","article-title":"The extinction of topical erythromycin therapy for acne vulgaris and concern for the future of topical clindamycin","volume":"28","author":"Austin","year":"2017","journal-title":"J. Dermatol. Treat."}],"container-title":["Antibiotics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2079-6382\/12\/9\/1455\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T20:53:20Z","timestamp":1760129600000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2079-6382\/12\/9\/1455"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,19]]},"references-count":26,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2023,9]]}},"alternative-id":["antibiotics12091455"],"URL":"https:\/\/doi.org\/10.3390\/antibiotics12091455","relation":{},"ISSN":["2079-6382"],"issn-type":[{"value":"2079-6382","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,19]]}}}