Metronidazole 2% Gel Versus Clindamycin 1% Gel for Moderate Acne Vulgaris

Summary

Acne vulgaris is a common inflammatory skin disorder. This randomized controlled trial (RCT) will compare the efficacy and safety of 2% metronidazole gel versus 1% clindamycin gel in adults with moderate acne vulgaris at Jinnah Postgraduate Medical Centre (JPMC), Karachi. Sixty eligible participants (18-35 years) will be enrolled using consecutive sampling and randomized in a 1:1 ratio using blocked randomization. Participants will apply the assigned gel as a thin layer twice daily for 12 weeks. Acne severity will be assessed using the Modified Global Acne Grading System (mGAGS) at baseline and at weeks 4, 8, and 12. The primary outcome is the proportion of participants achieving at least a 50% reduction from baseline in total mGAGS score at week 12. Local adverse effects (e.g., erythema, itching, irritation) will be recorded at each follow-up visit.

Timeline

Start

2026-02

Primary completion

2026-08

Completion

2026-08

Publications

• Results 20. 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. Natl J Physiol Pharm Pharmacol. 2022;12(6):817-822.
• Results Irshad M, Syed AW, Shahid MW, Naeem U, Mirza M, Naeem S. Comparative Effects of Azithromycin and Probiotics for Treatment of Acne Vulgaris. J Coll Physicians Surg Pak. 2023 May;33(5):516-520. doi: 10.29271/jcpsp.2023.05.516.
• Results Naveed S, Masood S, Rahman A, Awan S, Tabassum S. Impact of acne on quality of life in young Pakistani adults and its relationship with severity: A multicenter study. Pak J Med Sci. 2021 May-Jun;37(3):727-732. doi: 10.12669/pjms.37.3.2819.
• Results Dessinioti C, Katsambas A. Antibiotics and Antimicrobial Resistance in Acne: Epidemiological Trends and Clinical Practice Considerations. Yale J Biol Med. 2022 Dec 22;95(4):429-443. eCollection 2022 Dec.
• Results Dreno B, Dekio I, Baldwin H, Demessant AL, Dagnelie MA, Khammari A, Corvec S. Acne microbiome: From phyla to phylotypes. J Eur Acad Dermatol Venereol. 2024 Apr;38(4):657-664. doi: 10.1111/jdv.19540. Epub 2023 Oct 11.
• Results 15. Chen X, et al. Metronidazole: the clinical efficacy and pharmacological effects. Biomedicines. 2023;11(8):2153. doi:10.3390/biomedicines11082153
• Results Khodaeiani E, Fouladi RF, Yousefi N, Amirnia M, Babaeinejad S, Shokri J. Efficacy of 2% metronidazole gel in moderate acne vulgaris. Indian J Dermatol. 2012 Jul;57(4):279-81. doi: 10.4103/0019-5154.97666.
• Results Nakase K, Aoki S, Sei S, Fukumoto S, Horiuchi Y, Yasuda T, Tanioka M, Sugai J, Huh WW, Kakuta M, Nomoto M, Shimada T, Watanabe M, Kobayashi M, Murakami S, Takeo C, Tsubouchi R, Hayashi N, Noguchi N. Characterization of acne patients carrying clindamycin-resistant Cutibacterium acnes: A Japanese multicenter study. J Dermatol. 2020 Aug;47(8):863-869. doi: 10.1111/1346-8138.15397. Epub 2020 May 18.
• Results Aoki S, Nakase K, Nakaminami H, Wajima T, Hayashi N, Noguchi N. Transferable Multidrug-Resistance Plasmid Carrying a Novel Macrolide-Clindamycin Resistance Gene, erm(50), in Cutibacterium acnes. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01810-19. doi: 10.1128/AAC.01810-19. Print 2020 Feb 21.
• Results Koyanagi S, Koizumi J, Nakase K, Hayashi N, Horiuchi Y, Watanabe K, Asai T, Yamazaki A, Nakazaki E, Nakaminami H. Increased frequency of clindamycin-resistant Cutibacterium acnes strains isolated from Japanese patients with acne vulgaris caused by the prevalence of exogenous resistance genes. J Dermatol. 2023 Jun;50(6):793-799. doi: 10.1111/1346-8138.16757. Epub 2023 Mar 7.
• Results 10. Beig M, et al. Prevalence of antibiotic-resistant Cutibacterium acnes isolated from acne patients: a systematic review and meta-analysis. Lancet Reg Health Southeast Asia. 2024. doi:10.1016/j.lansea.2024.100137
• Results 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.
• Results 7. 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. Natl J Physiol Pharm Pharmacol. 2022;12(6):817-22
• Results 6. Rahim S, Kumar A. The impact of acne vulgaris on quality of life and psychic health in young adolescents of Rehman Medical College, Peshawar, Pakistan: a cross-sectional study. J Rehman Med Inst. 2024;8(1):1-5.
• Results Babar O, Mobeen A. Prevalence and Psychological Impact of Acne Vulgaris in Female Undergraduate Medical Students of Rawalpindi and Islamabad, Pakistan. Cureus. 2019 Sep 22;11(9):e5722. doi: 10.7759/cureus.5722.
• Results 3. Rahim S, Kumar A. The impact of acne vulgaris on quality of life and psychic health in young adolescents of Rehman Medical College, Peshawar, Pakistan: a cross-sectional study. J Rehman Med Inst. 2024;8(1):1-5

Drugs

Indications