An interventional study of Ascorbic acid and niacinamide in Melasma, sponsored by Pak Emirates Military Hospital. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Pak Emirates Military Hospital · Not applicable, Interventional, and Treatment
Melasma is a common acquired hyperpigmentation disorder that significantly affects quality of life. Various topical agents are used in its treatment, including Vitamin C and Niacinamide, both of which possess depigmenting properties. This randomized controlled trial aims to compare the efficacy of topical Vitamin C and topical Niacinamide in patients with melasma. A total of 100 patients will be enrolled and randomly allocated into two groups. Treatment efficacy will be assessed using the Melasma Area and Severity Index (MASI) score after 12 weeks of therapy. The findings of this study may help determine the more effective topical treatment option for melasma.
Background:
Melasma is a common acquired hyperpigmentation disorder characterized by symmetrical brown-to-gray facial macules and patches. It commonly affects women and has a significant psychosocial impact. Various topical agents have been used for its treatment. Vitamin C possesses antioxidant and depigmenting properties through inhibition of melanogenesis, whereas Niacinamide reduces melanosome transfer from melanocytes to keratinocytes and exerts anti-inflammatory effects.
Objective:
To compare the efficacy of topical 10% Vitamin C and topical 10% Niacinamide in the treatment of melasma.
Methods:
This randomized controlled trial will be conducted at the Department of Dermatology, Pakistan Emirates Military Hospital (PEMH), Rawalpindi. A total of 100 patients with clinically diagnosed melasma will be enrolled through non-probability consecutive sampling and randomized into two groups.
Group A: Topical Vitamin C 10% Group B: Topical Niacinamide 10% Both treatments will be applied for 12 weeks. Patients will undergo baseline assessment and follow-up evaluations using the Melasma Area and Severity Index (MASI) score.
Primary Outcome Measure:
Efficacy will be defined as greater than 50% reduction in MASI score from baseline after 12 weeks of treatment.
Statistical Analysis:
Data will be analyzed using SPSS version 26. Quantitative variables will be expressed as mean ± standard deviation, while qualitative variables will be presented as frequencies and percentages. Efficacy between the two treatment groups will be compared using appropriate statistical tests. A p-value ≤ 0.05 will be considered statistically significant.
Expected Significance:
This study aims to provide evidence regarding the comparative efficacy of topical 10% Vitamin C and topical 10% Niacinamide for melasma, which may help clinicians select an effective and safe treatment option for affected patients.
159 studies on the registry are indexed under Melanosis; 42 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 149 interventional studies indexed under Melanosis.
Browse Melanosis studies →Pak Emirates Military Hospital is the lead sponsor of 24 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
- 1. Pregnant or breastfeeding women. 2. History of allergies, sensitivity or adverse reactions to vitamin C or niacinamide.
3. Presence of other active dermatologic conditions like eczema, psoriasis, or acne that could confound the results
Drug: Ascorbic acid
Drug: niacinamide
participants assigned to this intervention will receive 10% topical ascorbic acid formulations for treatment of melasma. The formulations will be applied according to the frequency and duration specified in the study protocol.
Also known as: ascorbic acid 10 %
participants assigned to this intervention will receive a topical 10 % niacinamide formulation for the treatment of melasma. The formulation will be applied according to the frequency and duration specified in the study protocol.
change in MASI score
change in melasma area and severity index (MASI) score from baseline to the end of the treatment period in the participants treated with topical vitamin c compared with those with topical niacinamide
Time frame: Baseline to the end of the treatment period (12 weeks)
Plan to share: No — individual participation data will not be shared with other researhers.Only aggregates study results may be published while maintaining participant confidentiality.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ascorbic Acid · Niacinamide
Pak Emirates Military Hospital