A comparative study of efficacy and safety of topical clindamycin 1% gel versus topical dapsone 5% gel in acne vulgaris over face: a prospective randomized double-blind study
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20252569Keywords:
Acne vulgaris, Cardiff acne disability index, Inflammatory lesions, Investigator’s static global assessment, Topical clindamycin, Topical dapsoneAbstract
Background: Acne vulgaris is a common chronic condition in both adolescents and adults. While 1% clindamycin gel is a standard topical treatment, increasing antibiotic resistance limits its long-term use. Dapsone 5% gel, with anti-inflammatory and antimicrobial properties, is a potential alternative. This study compared the efficacy and safety of 5% dapsone gel versus 1% clindamycin gel in mild-to-moderate acne.
Methods: This 12-month prospective, randomized, double-blind study was conducted at the dermatology OPD, J.A. Group of Hospital, Gwalior, from November 2023 to October 2024. Eighty patients with facial acne were equally randomized into two groups: group 1 received clindamycin 1% gel; group 2 received dapsone 5% gel. Treatment was applied once daily at night for 12 weeks. Efficacy was assessed at baseline and weeks 4, 8, and 12 using the investigator’s global assessment (ISGA) and total lesion count (TLC). Safety and adverse drug reactions (ADRs) were recorded. The Hindi version of the Cardiff acne disability index (CADI) assessed psychosocial impact.
Results: Both groups showed significant improvement by week 12. Final ISGA scores were similar (clindamycin: 1.189±0.397; dapsone: 1.184±0.392; p=0.913). Lesion count reductions were also comparable (p=0.148). Dapsone was more effective for inflammatory lesions- papules (p=0.001) and pustules (p=0.000). Comedone reduction, ADRs (p=0.555), and CADI improvements (p=0.213) were similar.
Conclusions: Dapsone 5% gel showed efficacy comparable to clindamycin 1%, with superior results for inflammatory lesions. Both were well tolerated and improved quality of life, making dapsone a promising alternative.
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References
Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-73. DOI: https://doi.org/10.1016/j.jaad.2015.12.037
Chen H, Zhang TC, Yin XL, Man JY, Yang XR, Lu M. 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. Br J Dermatol. 2022;186(4):673-83. DOI: https://doi.org/10.1111/bjd.20882
Bondade S, Hosthota A, Basavaraju V. Stressful life events and psychiatric comorbidity in acne- a case control study. Asia Pac Psychiatr. 2019;11(1):e12340. DOI: https://doi.org/10.1111/appy.12340
Ak M. A comprehensive review of acne vulgaris. J Clin Pharm. 2019;1(1):17-45.
JJ L. Current issues in antimicrobial therapy for the treatment of acne. J Eur Acad Dermatol Venereol. 2001;15:17-27. DOI: https://doi.org/10.1046/j.0926-9959.2001.00013.x
Aubin GG, Portillo ME, Trampuz A, Corvec S. Propionibacterium acnes, an emerging pathogen: from acne to implant-infections, from phylotype to resistance. Med Malad Infect. 2014;44(6):241-50. DOI: https://doi.org/10.1016/j.medmal.2014.02.004
Guay DR. Topical clindamycin in the management of acne vulgaris. Exp Opin Pharmacother. 2007;8(15):2625-64. DOI: https://doi.org/10.1517/14656566.8.15.2625
Dreno B, Thiboutot D, Gollnick H, Bettoli V, Kang S, Leyden JJ, et al. Antibiotic stewardship in dermatology: limiting antibiotic use in acne. Eur J Dermatol. 2014;24:330-4. DOI: https://doi.org/10.1684/ejd.2014.2309
Wozel G, Blasum C. Dapsone in dermatology and beyond. Arch Dermatol Res. 2014;306(2):103-24. DOI: https://doi.org/10.1007/s00403-013-1409-7
Stotland M, Shalita AR, Kissling RF. Dapsone 5% gel: a review of its efficacy and safety in the treatment of acne vulgaris. Am J Clin Dermatol. 2009;10:221-7. DOI: https://doi.org/10.2165/00128071-200910040-00002
Alsulaimani H, Kokandi A, Khawandanh S, Hamad R. Severity of acne vulgaris: comparison of two assessment methods. Clin Cosm Investig Dermatol. 2020:711-6. DOI: https://doi.org/10.2147/CCID.S266320
Tan JK. Current measures for the evaluation of acne severity. Exp Rev Dermatol. 2008;3(5):595-603. DOI: https://doi.org/10.1586/17469872.3.5.595
Draelos ZD, Tanghetti EA, Kircik LH, Bhatia N, Zeichner JA, Sugarman JL, et al. Dermal sensitization, safety, and tolerability of triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel from three clinical trials. J Dermatol Treat. 2023;34(1):2220446. DOI: https://doi.org/10.1080/09546634.2023.2220446
Gupta A, Sharma YK, Dash K, Verma S. Cultural adaptation of the Cardiff acne disability index to a Hindi speaking population: a pilot study. Indian J Dermatol. 2015;60(4):419. DOI: https://doi.org/10.4103/0019-5154.160504
Tuchayi SM, Makrantonaki E, Ganceviciene R, Dessinioti C, Feldman SR, Zouboulis CC. Acne vulgaris. Nat Rev Dis Prim. 2015;1(1):1-20. DOI: https://doi.org/10.1038/nrdp.2015.29
Dréno B, Pécastaings S, Corvec S, Veraldi S, Khammari A, Roques C. Cutibacterium acnes (Propionibacterium acnes) and acne vulgaris: a brief look at the latest updates. J Eur Acad Dermatol Venereol. 2018;32:5-14. DOI: https://doi.org/10.1111/jdv.15043
Shah A, Sharma P, Raghuwanshi J, Mehra A, Bansal I, Bhindia J. A comparative study of efficacy of topical clindamycin 1% gel vs. topical dapsone 5% gel in the treatment of acne vulgaris. J Dermatol. 2024;15(1).
Verma R, Yadav P, Chudhari M, Patel J, Umrigar D. Comparison of efficacy of two topical drug therapy of acne vulgaris- 1% clindamycin versus 5% dapsone: a split face comparative study. Nat J Physiol Pharm Pharmacol. 2022;12(6):817-. DOI: https://doi.org/10.5455/njppp.2022.12.03100202221042022
Hayashi N, Kurokawa I, Siakpere O, Endo A, Hatanaka T, Yamada M, et al. Clindamycin phosphate 1.2%/benzoyl peroxide 3% fixed‐dose combination gel versus topical combination therapy of adapalene 0.1% gel and clindamycin phosphate 1.2% gel in the treatment of acne vulgaris in Japanese patients: a multicenter, randomized, investigator‐blind, parallel‐group study. J Dermatol. 2018;45(8):951-62. DOI: https://doi.org/10.1111/1346-8138.14497
Islam R, Islam MN, Hossain MM. An assessment of the efficacy and safety of dapsone gel: study in a local setting. Sch J App Med Sci. 2021;9(4). DOI: https://doi.org/10.36347/sjams.2021.v09i04.012
Wang X, Wang Z, Sun L, Liu H, Zhang F. Efficacy and safety of dapsone gel for acne: a systematic review and meta-analysis. Ann Palliat Med. 2022;11(2):61120-620. DOI: https://doi.org/10.21037/apm-21-3935
Tan J. Dapsone 5% gel: a new option in topical therapy for acne. Skin Ther Lett. 2012;17(8):1-3.
Karadag AS, Aslan Kayıran M, Wu CY, Chen W, Parish LC. Antibiotic resistance in acne: changes, consequences and concerns. J Eur Acad Dermatol Venereol. 2021;35(1):73-8. DOI: https://doi.org/10.1111/jdv.16686
Zydus Lifesciences Limited. Zydus receives final approval from USFDA for dapsone gel, 7.5%. Ahmedabad: Zydus Lifesciences; 2024. Available from: https://zyduslife.com/investor/admin/uploads/ 21/83/Zydus-receives-final-approval-from-USFDA-for-Dapsone-Gel--7-5-.pdf. Accessed on 22 May 2025.
Dallo M, Patel K, Hebert AA. Topical antibiotic treatment in dermatology. Antibiotics. 2023;12(2):188. DOI: https://doi.org/10.3390/antibiotics12020188
MacGibeny MA, Jo JH, Kong HH. Antibiotic stewardship in dermatology- reducing the risk of prolonged antimicrobial resistance in skin. JAMA Dermatol. 2022;158(9):989-91. DOI: https://doi.org/10.1001/jamadermatol.2022.3168
Nickles MA, Lake E. Topical dapsone in the treatment of acne: a systematic review. Int J Dermatol. 2022;61(11):1412-21. DOI: https://doi.org/10.1111/ijd.16074
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