A randomised comparative study to evaluate the efficacy and safety of thirty percent metformin cream versus triple combination cream versus tranexamic acid cream in the treatment of melasma

This study will be a prospective randomized controlled study, open label conducted after obtaining approval and clearance from the Institutional ethics committee (IEC). 120 patients of melasma more than 18 years of age attending our dermatology outpatient department fulfilling the inclusion and exclusion criteria will be enrolled for the study.

Patients will be randomized into 1:1:1 ratio using simple random sampling technique.

1. Group A patients will receive sunscreen with spf 30 in the morning and 30% metformin cream at night.

2.  2. Group B  patients will receive sunscreen with spf 30 in the morning and topical triple combination cream at night (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01% combination cream).

3.  3. Group C will receive sunscreen with spf 30 in the morning and topical 10 % tranexamic acid cream at night.

Metformin lotion will be prepared by mixing 30 g of metformin powder with 70% alcohol and propylene glycol in 30% weight: volume ratio. 30 % Metformin preparation can be stored at room temperature for 4-6 weeks after preparation.

A detailed clinical history will be taken in terms of demographic data, age, sex, occupation, presenting complaints, past history, treatment history, family history duration of skin lesions, course and progression of disease and clinical examination findings will be recorded in the case record form and Dermoscopy will be done to assess the depth of pigmentation. Photographs will be taken. Patch testing with metformin will be done.

After taking baseline photographs, the severity of melasma will be scored with Melasma area and severity index (MASI) score as described by Kimbrough‐Green et al.1

All groups will receive the treatment and MASI score will be assessed at 4 weeks, 8 weeks and 12 weeks follow up along with simultaneous serial digital photographs and recording of side effects if any. The patients will be followed up for 3 months after stopping treatment. The duration of the study will be 6 months. The improvement in melasma will be graded according to global improvement scale as grade 0: no improvement; grade 1: mild improvement (1% to 50%‐75%); and grade 4: near total/total improvement (>75%). Subjective assessment will be done by patients based on the level of satisfaction with the treatment and will be scored on a scale of 0‐4 as score 0‐no improvement, 1‐poor; 2‐slightly satisfied; 3‐satisfied; and 4‐highly satisfied. Analysis will also be done by one independent assessor not included in the trial.

References:

1.      Kimbrough‐Green CK, Griffiths CE, Finkel LJ, et al. Topical retinoic acid (tretinoin) for melasma in black patients. A vehicle‐controlled clinical trial. Arch Dermatol. 1994; 130:727‐33.