Melasma
Conditions
Keywords
Melasma Vitamin C Niacinamide Topical treatment Hyperpigmentation Randomized controlled trial Comparative efficacy Facial pigmentation
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 1.Patients aged 18-50 years 2.Every patient who has had melasma for more than eight weeks, according to the operational criteria. 3.A MASI score greater than 8.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in MASI score | Baseline to the end of the treatment period (12 weeks) | 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 |
Countries
Pakistan