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

Jinnah Postgraduate Medical Centre

Status: Completed

Conditions: Melasma

Treatments: Drug: Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%); Drug: Broad-spectrum sunscreen (SPF ≥30); Drug: Metformin gel, 30%

Study type: Interventional

Funder types: Other

Identifiers

NCT07345507

F.2-81/2024-GENL/24/JPMC

Details and patient eligibility

About

This study will compare two topical treatments for melasma. Participants will be randomly assigned to receive either triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%) or 30% metformin gel, applied once nightly for 12 weeks. All participants will use broad-spectrum sunscreen (SPF ≥30) during the daytime throughout the treatment period. Melasma severity will be assessed using the Melasma Area and Severity Index (MASI), and the study will determine which treatment is more effective and better tolerated at the end of 12 weeks.

Full description

This randomized, parallel-group clinical trial will be conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan, after approval from the Institutional Review Board/Ethics Committee of JPMC. Eligible patients presenting with clinically diagnosed melasma will be screened and enrolled after obtaining written informed consent.

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18- 60 years of either gender.
• Diagnosed with melasma based on clinical examination and Wood's lamp assessment.

Exclusion criteria

• Pregnant or lactating women.
• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Group A (TRIPLE COMBINATION THERAPY GROUP)

Active Comparator group

Description:

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.

Treatment:

Drug: Broad-spectrum sunscreen (SPF ≥30)

Drug: Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%)

Group B ( METFORMIN 30% GEL THERAPY GROUP )

Experimental group

Description:

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.

Treatment:

Drug: Metformin gel, 30%

Drug: Broad-spectrum sunscreen (SPF ≥30)