Efficacy and Safety of Topical Metformin 30% in the Treatment of Melasma Compared to Triple Combination Cream(0.05% tretinoin, 2% hydroquinone, 0.01% fluocinolone acetonide)

To evaluate and compare the efficacy of topical metformin 30% versus triple combination cream in treatment of melasma.

Community based, parallel group, double blind, randomized control trial

Participants of study meeting the inclusion criteria will be allotted two groups by lottery method of randomization. Melasma severity and Quality of life will be recorded as MASI score and MelasQoL respectively at the base line.Group A will receive topical metformin 30% cream at night while group B will receive topical triple combination cream at night.Participants will be blinded to what treatment they are getting. Both the groups will be assessed at 4 week, 8 week and 12 weeks and MASI, melasQoL, patient satisfaction and adverse effects will be recorded by an independent assessor. Participants will be assessed again at 16 week to assess recurrence. Study will be conducted at CMH, Quetta, Pakistan.

Inclusion Criteria- Adults aged 18- 60 with melasma, Fitzpatrick skin type III-V, no other melasma Exclusion Criteria: Use of photosensitizing drugs like phenytoin, tetracycline etc, pregnancy, lactation, renal disease, liver disease, history of recent laser treatment or hypersensitivity to metformin or triple combination cream

Group A- topical metformin 30% cream at night Group B- topical triple combination cream at night

Primary Outcomes- Safety and efficacy Secondary outcomes- Quality of life, patient satisfaction, recurrence

Two groups are made by simple lottery method Group 1: Topical metformin 30% cream applied once daily at night. Group 2: Triple Combination Cream (0.05% tretinoin, 2% hydroquinone, 0.01% fluocinolone acetonide) applied once daily at night.

Double blind study (both participant and data analyzer are blinded)