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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.
This is an investigator-initiated, parallel-group randomized controlled trial (RCT) conducted in the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. After approval from the Institutional Review Board (IRB) and the College of Physicians and Surgeons Pakistan (CPSP), adults aged 18-35 years with moderate acne vulgaris, defined by a Modified Global Acne Grading System (mGAGS) score of 45-80, and not using other anti-acne therapies will be enrolled using non-probability consecutive sampling. Participants who are pregnant or lactating, have severe acne (mGAGS >80), have a known allergy to metronidazole or clindamycin, or have other dermatologic conditions affecting the face will be excluded.
Participants will be randomized in a 1:1 allocation using blocked randomization to receive either metronidazole 2% gel or clindamycin 1% gel. The assigned treatment will be applied as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying of the face. Concomitant anti-acne products will be discouraged during the intervention period. Follow-up assessments will occur at weeks 4, 8, and 12. At each visit, acne severity will be assessed using mGAGS, and tolerability will be evaluated by recording local adverse effects, including erythema, itching, dryness, burning, or irritation.
The primary endpoint is treatment response at week 12, defined as a ≥50% reduction in total mGAGS score from baseline. Participants will be classified as responders (≥50% reduction) or non-responders (<50% reduction). Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Categorical outcomes will be compared using the chi-square test or Fisher's exact test, and continuous variables will be compared using the independent-samples t test or Mann-Whitney U test according to data distribution. Stratified analyses will explore effect modification by age and sex. A two-sided p value ≤0.05 will be considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole 2% Gel | Experimental | Participants will apply 2% metronidazole gel as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying. |
|
| Clindamycin 1% Gel | Active Comparator | Participants will apply 1% clindamycin gel as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole Topical Gel 2% | Drug | Topical metronidazole gel 2% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response by mGAGS at Week 12 | Proportion of participants achieving ≥50% reduction in total Modified Global Acne Grading System (mGAGS) score from baseline (Responder = Yes; Non-responder = No). | 12 weeks |
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Inclusion Criteria
Adults aged 18-35 years of either sex.
Clinical diagnosis of moderate acne vulgaris, defined as a Modified Global Acne Grading System (mGAGS) score of 45-80.
Not currently using any other anti-acne treatment (topical or systemic).
Exclusion Criteria
Pregnant or lactating women.
Severe acne vulgaris, defined as an mGAGS score >80.
Known hypersensitivity/allergy to metronidazole or clindamycin (or any component of the study gels).
Any other dermatologic condition affecting the face that may interfere with assessment of acne severity or treatment response.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rubab Murtaza, FCPS | Contact | 0334 2341118 | rubabumer96@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 37190684 | Result | 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. | |
| 34104156 |
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Individual participant data (IPD) will not be shared outside the study team. Data will be stored securely at the study site and used only for the purposes described in the protocol. Aggregate, de-identified results will be reported in publications
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Parallel-group, two-arm randomized controlled trial. Eligible participants with moderate acne vulgaris will be randomized in a 1:1 ratio using blocked randomization to receive either 2% metronidazole gel or 1% clindamycin gel, applied twice daily for 12 weeks, with follow-up assessments at weeks 4, 8, and 12.
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| Clindamycin Topical Gel 1% | Drug | Topical clindamycin gel 1% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying. |
|
| Result |
| 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. |
| 36568833 | Result | 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. |
| 37777343 | Result | 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. |
| Result | 15. Chen X, et al. Metronidazole: the clinical efficacy and pharmacological effects. Biomedicines. 2023;11(8):2153. doi:10.3390/biomedicines11082153 |
| 22837561 | Result | 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. |
| 32424832 | Result | 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. |
| 31844016 | Result | 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. |
| 36880295 | Result | 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. |
| Result | 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 |
| 38300170 | Result | 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. |
| Result | 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 |
| Result | 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. |
| 31720190 | Result | 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. |
| Result | 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 |