Comparison of Efficacy of Metformin Gel 30% vs Triple Combination Cream (Hydroquinone 4%, Flucinolone Acetonide 0.01%, Tretinoin 0.025%) in Treatment of Melasma in Tertiary Care Hospital Karachi
NCT ID: NCT07345507
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2025-02-01
2025-08-30
Brief Summary
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Detailed Description
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Participants will be randomly assigned in a 1:1 ratio to one of two treatment arms using a computer-generated randomization sequence. Group A (active comparator) will receive topical triple combination cream containing hydroquinone 2%, tretinoin 0.025%, and fluocinolone acetonide 0.01%, applied once nightly to affected facial areas for 12 weeks. Group B (experimental) will receive topical metformin gel 30%, applied once nightly to melasma-affected areas for 12 weeks. All participants in both arms will be advised to apply broad-spectrum sunscreen (SPF ≥30) during daytime throughout the treatment period.
Melasma severity will be assessed using the Melasma Area and Severity Index (MASI) at baseline and during follow-up visits over the 12-week treatment period. The primary outcome will be the proportion of participants achieving at least a 50% reduction in total MASI score from baseline at week 12. Safety and tolerability will be monitored throughout the study by documenting adverse effects reported by participants or observed on clinical examination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Group A (TRIPLE COMBINATION THERAPY GROUP)
Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%) applied nightly for 12 weeks. All participants also used broad-spectrum sunscreen (SPF ≥30) during daytime.
Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%)
Topical triple combination cream containing hydroquinone 2%, tretinoin 0.025%, and fluocinolone acetonide 0.01%, applied once nightly to affected facial areas for 12 weeks
Broad-spectrum sunscreen (SPF ≥30)
Applied during daytime throughout the 12-week treatment period (both arms)
Group B ( METFORMIN 30% GEL THERAPY GROUP )
Participants will apply 30% metformin gel topically to melasma-affected areas once nightly for 12 weeks. All participants will also use broad-spectrum sunscreen (SPF ≥30) during daytime.
Metformin gel, 30%
Participants will apply 30% metformin gel topically to melasma-affected areas once nightly for 12 weeks. All participants will also use broad-spectrum sunscreen (SPF ≥30) during daytime.
Broad-spectrum sunscreen (SPF ≥30)
Applied during daytime throughout the 12-week treatment period (both arms)
Interventions
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Metformin gel, 30%
Participants will apply 30% metformin gel topically to melasma-affected areas once nightly for 12 weeks. All participants will also use broad-spectrum sunscreen (SPF ≥30) during daytime.
Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%)
Topical triple combination cream containing hydroquinone 2%, tretinoin 0.025%, and fluocinolone acetonide 0.01%, applied once nightly to affected facial areas for 12 weeks
Broad-spectrum sunscreen (SPF ≥30)
Applied during daytime throughout the 12-week treatment period (both arms)
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with melasma based on clinical examination and Wood's lamp assessment.
Exclusion Criteria
* Patients with a history of hypersensitivity to any study medication components.
* Patients currently on other melasma treatments or those with other dermatologic conditions affecting pigmentation.
18 Years
60 Years
ALL
No
Sponsors
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Jinnah Postgraduate Medical Centre
OTHER_GOV
Responsible Party
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Dr Summiya Shakeel Ahmed
FCPS part 2 Trainee dermatology
Locations
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JPMC
Karachi, Sindh, Pakistan
Countries
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References
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Grimes PE, Pandya AG, Taylor SC, Rendon MI. Challenges in melasma treatment: need for standardization and multicenter RCTs. Dermatol Ther. 2022;35(1):e15234. doi:10.1111/dth.15234
Steiner D, Pandya AG. Melasma and hormonal imbalance: an evidence-based review. J Eur Acad Dermatol Venereol. 2021;35(8):1630-40. doi:10.1111/jdv.17123
Del Rosario E, Florell SR, Zone JJ. Gender and hormonal differences in melasma pathogenesis. Int J Womens Dermatol. 2023;9(2):95-103. doi:10.1016/j.ijwd.2023.02.004
Coondoo A, Phiske M, Verma S, Lahiri K. Side-effects of topical steroids: A long overdue revisit. Indian Dermatol Online J. 2014 Oct;5(4):416-25. doi: 10.4103/2229-5178.142483.
Misitzis D, Georgala S, Katoulis AC. Comparison of the effectiveness and safety of triple combination cream vs hydroquinone monotherapy in melasma. J Cosmet Dermatol. 2022;21(9):3882-7. doi:10.1111/jocd.14278
Frances L, Cuesta L, Leiva-Salinas M, Banuls J. Secondary mucinous carcinoma of the skin. Dermatol Online J. 2014 Apr 16;20(4):22361.
Lima EVA, Lima MA, Paixão MP, Miot HA. Assessment of the efficacy of a triple combination cream for melasma in different populations: a literature review. Clin Cosmet Investig Dermatol. 2020;13:505-10. doi:10.2147/CCID.S238536
Pomeranz MK, Belsito DV. Mechanisms of postinflammatory hyperpigmentation and therapeutic strategies. Clin Dermatol. 2020;38(1):64-72. doi:10.1016/j.clindermatol.2019.06.009
Lee AY. Anti-melanogenic effects of metformin: beyond diabetes. J Dermatol Sci. 2021;104(1):1-8. doi:10.1016/j.jdermsci.2021.06.002
González-Pedraza A, Salazar-Aranda R, Pérez-Herrera P, Torres-Torres Y. Metformin as an adjuvant in dermatology: molecular mechanisms and clinical applications. Int J Dermatol. 2023;62(2):132-40. doi:10.1111/ijd.16391
Mahmoud MMY, Kamel AM, Galal SA. Evaluation the efficacy of microneedling with topical metformin solution compared with microneedling with topical vitamin C solution in treatment of melasma. Arch Dermatol Res. 2024 Oct 5;316(9):662. doi: 10.1007/s00403-024-03355-9.
Ali Mapar M, Namdari G. Efficacy of topical metformin 15% vs placebo in melasma: RCT over 12 weeks. J Cosmet Dermatol. 2019;18(5):1357-63. doi:10.1111/jocd.12904
Gan C, Rodrigues M. An Update on New and Existing Treatments for the Management of Melasma. Am J Clin Dermatol. 2024 Sep;25(5):717-733. doi: 10.1007/s40257-024-00863-2. Epub 2024 Jun 19.
AboAlsoud ES, Eldahshan RM, AbouKhodair Mohammed H, Elsaie ML. Safety and efficacy of topical metformin 30% cream versus triple combination cream (Kligman's formula) in treating melasma: A randomized controlled study. J Cosmet Dermatol. 2022 Jun;21(6):2508-2515. doi: 10.1111/jocd.14953. Epub 2022 Apr 9.
Mapar MA, Hemmati AA, Namdari G. Comparing the efficacy of topical metformin and placebo in the treatment of melasma: a randomized, double-blind clinical trial. J Pharm Res Int. 2019;30(4):1-8. doi:10.9734/JPRI/2019/v30i430276
Banavase Channakeshavaiah R, Andanooru Chandrappa NK. Topical metformin in the treatment of melasma: A preliminary clinical trial. J Cosmet Dermatol. 2020 May;19(5):1161-1164. doi: 10.1111/jocd.13145. Epub 2019 Sep 10.
Mongkhon P, Ruengorn C, Awiphan R, Phosuya C, Ruanta Y, Thavorn K, Jamjanya S, Chuamanochan M, Nochaiwong S. Efficacy and safety of metformin for melasma treatment: a systematic review and meta-analysis. Front Pharmacol. 2023 Dec 13;14:1281050. doi: 10.3389/fphar.2023.1281050. eCollection 2023.
Ahmad Nasrollahi S, Sabet Nematzadeh M, Samadi A, Ayatollahi A, Yadangi S, Abels C, Firooz A. Evaluation of the safety and efficacy of a triple combination cream (hydroquinone, tretinoin, and fluocinolone) for treatment of melasma in Middle Eastern skin. Clin Cosmet Investig Dermatol. 2019 Jun 10;12:437-444. doi: 10.2147/CCID.S202285. eCollection 2019.
Atwa MA, Ahmed AH, Nada HA, Refaey SM, Jafferany M, Elsaie ML. Combined chemical peels versus trichloroacetic acid (TCA) for treating melasma: a split face study. J Dermatolog Treat. 2022 Mar;33(2):959-964. doi: 10.1080/09546634.2020.1793888.
Passeron T. Melasma pathogenesis and updated treatment options. J Eur Acad Dermatol Venereol. 2022;36(6):859-68. doi:10.1111/jdv.18101
Neagu N, Conforti C, Agozzino M, Marangi GF, Morariu SH, Pellacani G, Persichetti P, Piccolo D, Segreto F, Zalaudek I, Dianzani C. Melasma treatment: a systematic review. J Dermatolog Treat. 2022 Jun;33(4):1816-1837. doi: 10.1080/09546634.2021.1914313. Epub 2022 Mar 23.
Rahman A, Basit A, Mohsin S, Ahmed N, Tahir M, Ishfaq A. Quality of life of melasma patients in Pakistan. Pak Armed Forces Med J. 2022;72(1):307-10.
Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. doi: 10.1590/abd1806-4841.20143063.
Kang HY, Ortonne JP. Melasma update. Acta Dermatovenerol Alp Pannonica Adriat. 2009;18(2):137-42
Other Identifiers
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F.2-81/2024-GENL/24/JPMC
Identifier Type: -
Identifier Source: org_study_id
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