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

NCT07392047 | Not Yet Recruiting Phase 4

• 1 other identifier: JPMC-ACNE-RCT-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acne Vulgaris

Keywords

Moderate acne; Metronidazole gel; Clindamycin gel; Topical antibiotic; Modified Global Acne Grading System

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Metronidazole Topical Gel 2%

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.

Drug: Clindamycin Topical Gel 1%

Interventions

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.

Metronidazole 2% Gel

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.

Clindamycin 1% Gel

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Related Publications (20)

• 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.

  RESULT

• 19. Irshad M, Syed AW, Shah MW, Naeem U, Mirza M, Naeem S. Comparative effects of azithromycin and probiotics for treatment of acne vulgaris. J Coll Physicians Surg Pak. 2023;33(5):516-520.

  RESULT

• 18. 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;37(3):727-732. doi:10.12669/pjms.37.3.2819

  RESULT

• 17. Dessinioti C, Katsambas A. Antibiotics and antimicrobial resistance in acne: epidemiological trends and clinical practice considerations. Yale J Biol Med. 2022;95(1):53-63.

  RESULT

• 16. Dréno B, Corvec S, et al. Acne microbiome: From phyla to phylotypes. J Eur Acad Dermatol Venereol. 2024;38(4):657-664. doi:10.1111/jdv.19540

  RESULT

• 15. Chen X, et al. Metronidazole: the clinical efficacy and pharmacological effects. Biomedicines. 2023;11(8):2153. doi:10.3390/biomedicines11082153

  RESULT

• 14. 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;57(4):279-281. doi:10.4103/0019-5154.97666

  RESULT

• 13. Nakase K, Aoki S, Sei S, Fukumoto S, Horiuchi Y, Yasuda T, et al. Characterization of acne patients carrying clindamycin-resistant Cutibacterium acnes: a Japanese multicenter study. J Dermatol. 2020;47(8):863-869. doi:10.1111/1346-8138.15397

  RESULT

• 12. 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;64(3):e01810-19. doi:10.1128/AAC.01810-19

  RESULT

• 11. Koyanagi S, Koizumi J, Nakase K, Hayashi N, Horiuchi Y, Watanabe K, et al. 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;50(6):793-799. doi:10.1111/1346-8138.16757

  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

  RESULT

• 9. American Academy of Dermatology. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024. doi:10.1016/j.jaad.2023.12.017

  RESULT

• 8. 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;57(4):279-81.

  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.

  RESULT

• 5. Babar O, Mobeen A. Prevalence and psychological impact of acne vulgaris in female undergraduate medical students of Rawalpindi and Islamabad, Pakistan. Cureus. 2019;11(10)

  RESULT

• 4. Irshad M, Syed AW, Shah MW, Naeem U, Mirza M, Naeem S. Comparative effects of azithromycin and probiotics for treatment of acne vulgaris. J Coll Physicians Surg Pak. 2023;33(5):516-20.

  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

  RESULT

• 2. Babar O, Mobeen A. Prevalence and psychological impact of acne vulgaris in female undergraduate medical students of Rawalpindi and Islamabad, Pakistan. Cureus. 2019;11(10)

  RESULT

• 1. Irshad M, Syed AW, Shah MW, Naeem U, Mirza M, Naeem S. Comparative effects of azithromycin and probiotics for treatment of acne vulgaris. J Coll Physicians Surg Pak. 2023;33(5):516-20.

  RESULT

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Rubab Murtaza, FCPS

CONTACT

0334 2341118; rubabumer96@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Resident

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share