Comparison of Metformin plus Nicotinamide Solution with Kligman formula in the management of Melasma- a Clinical Trial in a Tertiary Care Hospital
DOI:
https://doi.org/10.51253/pafmj.v76iSUPPL-2.10432Keywords:
Melasma, Metformin, NicotinamideAbstract
Objective: To compare 30% Metformin plus 2% Nicotinamide solution with Kligman formula in the management of melasma in patients managed at tertiary care hospital of Rawalpindi.
Study Design: Randomized controlled trial (ClinicalTrials.gov: NCT 05790577).
Place and Duration of Study: Department of Dermatology, Pak Emirates Military Hospital, Rawalpindi Pakistan, from Feb 2022 to Feb 2023.
Methodology: A total of eighty-eight patients of melasma were recruited for this trial and allocated randomly into two groups: A and B. Group-A received the 30% metformin plus 2% nicotinamide solution while Group-B received the Kligman formula (fluocinolone acetonide 0.01%+ tretinoin 0.025% + hydroquinone 2%). Both groups were followed up for 12 weeks to look for response which was assessed on Melasma Area and Severity Index (MASI). MASI was calculated at the start of treatment, and at 4, 8 and 12 weeks. Adverse events such as itching and burning were noted and addressed at each visit.
Results: Out of eighty-eight patients, 66(75.0%) were females while 22(25.0%) were males. Mean age of the study participants was 30.93±7.94 years. Out of 44 patients in Group-A, 13(29.0%) showed mild improvement, 21(47.0%) patients showed moderate while marked improvement was seen in 4(9.0%) patients. In Group-B, out of 44 patients grade 1, 2, 3 and 4 improvements were seen in 14(31.81%) mild, 26(59.0%) moderate, 03(9.0%) marked and total improvement in one patient, respectively. Adverse effects were ....
Conclusion: Both the treatment options used, 30% metformin with 2% nicotinamide solution and Kligman formula were equally efficacious in management of ..
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References
1. Zhu Y, Zeng X, Ying J, Cai Y, Qiu Y, Xiang W. Evaluating the quality of life among melasma patients using the MELASQoL scale: A systematic review and meta-analysis. Plos One 2022; 17(1): e0262833.
https://doi.org/10.1371/journal.pone.0262833
2. González-Molina V, Martí A, González N. Topical treatments for Melasma and their mechanism of action. J Clin Aesthet Dermatol 2022; 15(5): 19-28.
3. Neagu N, Conforti C, Agozzino M, Marangi GF, Morariu SH, Pellacani G, et al. Melasma treatment: a systematic review. J Dermatol Treat 2022; 33(4): 1816-1837.
https://doi.org/10.1080/09546634.2021.1914313
4. T Jadotte Y, A Schwartz R. Melasma: insights and perspectives. Acta Dermatovenerol Croat 2010; 18(2): 124-129.
5. Mongkhon P, Ruengorn C, Awiphan R, Phosuya C, Ruanta Y, Thavorn K, et al. Efficacy and safety of metformin for melasma treatment: a systematic review and meta-analysis. Front Pharmacol 2023 14(1): 1281050.
https://doi.org/10.3389/fphar.2023.1281050
6. Chang YF, Lee TL, Oyerinde O, Desai SR, Aljabban A, Bay CP, et al. Efficacy and safety of topical agents in the treatment of melasma: What's evidence? A systematic review and meta‐analysis. J Cosmet Dermatol 2023; 22(4): 1168-1176.
https://doi.org/10.1111/jocd.15566
7. El-Komy MH, Elnowaihy SW, Shamma RN, Bedair NI. Efficacy and safety of a novel weekly topical metformin-loaded peel-off mask in the treatment of melasma: a split-face, placebo-controlled study. Clin Exp Dermatol 2024; 49(12): 1633-1640.
https://doi.org/10.1093/ced/llae274
8. Rolfe HM. A review of nicotinamide: treatment of skin diseases and potential side effects. J Cosmet Dermatol 2014; 13(4): 324-328. https://doi.org/10.1111/jocd.12119
9. Kimbrough-Green CK, Griffiths CE, Finkel LJ, Hamilton TA, Bulengo-Ransby SM, Ellis CN. Topical retinoic acid (tretinoin) for melasma in black patients: a vehicle-controlled clinical trial. Arch Dermatol 1994; 130(6): 727-733.
https://doi.org/10.1001/archderm.1994.01690060057005
10. Yalçın HT, Çakır DA, Yirün A, Sanajou S, Işık G, Bozdemir Ö, et al. Comparative in vitro and in silico evaluation of the toxic effects of metformin and/or ascorbic acid, new treatment options in the treatment of Melasma. Toxicol Res 2025; 14(1): tfaf025. https://doi.org/10.1093/toxres/tfaf025
11. Kwon SH, Na JI, Huh CH, Park KC. A Clinical and Biochemical Evaluation of a Temperature-Controlled Continuous Non-Invasive Radiofrequency Device for the Treatment of Melasma. Ann Dermatol 2021; 33(6): 522.
https://doi.org/10.5021/ad.2021.33.6.522
12. Monte-Serrano J, Villagrasa-Boli P, Cruanes-Monferrer J, Arbués-Espinosa P, Martínez-Cisneros S, García-Gil MF. The role of metformin in the treatment of dermatological diseases: A narrative review. Aten Primaria 2022; 54(6): 102354.
https://doi.org/10.1016/j.aprim.2022.102354
13. Saleh FY, Abdel-Azim ES, Mohamed ZS. Study of wood’s lamp and dermoscopic features of melasma. Minia J Med Res 2019; 30(1): 66-67.
14. Rachmin I, Ostrowski SM, Weng QY, Fisher DE. Topical treatment strategies to manipulate human skin pigmentation. Adv Drug Del Rev 2020; 153(1): 65-71.
https://doi.org/10.1016/j.addr.2020.02.002
15. Banavase R, Andanooru NK. Topical metformin in the treatmentof melasma: A preliminary clinical trial. J Cosmet Dermatol 2020; 19(5): 1161-1164.
https://doi.org/10.1111/jocd.13145
16. 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; 21(6): 2508-2515.
https://doi.org/10.1111/jocd.14953
17. Bronzina E, Clement A, Marie B, Fook KT, Faure P, Passeron T. Efficacy and tolerability on melasma of a topical cosmetic product acting on melanocytes, fibroblasts and endothelial cells: a randomized comparative trial against 4% hydroquinone. J Eur Acad Dermatol Venereol 2020; 34(4): 897-903. https://doi.org/10.1111/jdv.16150
18. Boo YC. Mechanistic basis and clinical evidence for the applications of nicotinamide (niacinamide) to control skin aging and pigmentation. Antioxidants 2021; 10(8): 1315.
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Copyright (c) 2026 Ishtiaq Ahmed, Qamar-Ud-Din Khan, Uzma Naeem, Aysha Shabbir, M Shahid Khan, Umar Abdul Ali

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