Melasma
Conditions
Keywords
Melasma, Efficacy, METFORMIN GEL, HYDROQUINONE 2%, TRETINOIN 0.025%
Brief summary
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.
Detailed 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.
Interventions
DRUGMetformin 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.
DRUGTriple 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
DRUGBroad-spectrum sunscreen (SPF ≥30)
Applied during daytime throughout the 12-week treatment period (both arms)
Sponsors
Jinnah Postgraduate Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with ≥50% reduction in MASI score from baseline at 12 weeks. | 12 weeks (end of treatment) | The Melasma Area and Severity Index (MASI) will be used to assess the severity of melasma. The MASI score is calculated based on the area of involvement, darkness, and homogeneity on four facial regions. Participants achieving ≥50% reduction in total MASI score from baseline at week 12 will be classified as treatment responders. Data will be reported as the number and percentage of responders in each treatment arm and compared between arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in MASI score from baseline to 12 weeks. | 2 weeks (end of treatment) | MASI score will be measured at baseline and at week 12. The mean change in MASI score from baseline to week 12 will be calculated for each treatment arm. |
| Frequency of treatment-related adverse effects during the 12-week treatment period. | 12 weeks (during treatment) | Adverse effects (e.g., erythema, burning, irritation, dryness) will be assessed and recorded at follow-up visits during the treatment period. Results will be summarized as the number and percentage of participants experiencing any adverse effect in each arm |
Countries
Pakistan
Outcome results
None listed