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COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA

COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07890571
Enrollment
100
Registered
2026-10-22
Start date
2026-11-01
Completion date
2027-09-01
Last updated
2026-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

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

DRUGAscorbic acid

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

Pak Emirates Military Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

MeasureTime frameDescription
change in MASI scoreBaseline 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

Contacts

CONTACTDr Hasnain Abbas, MBBS/FCPS Dermatology Resident
drhasnain12@gmail.com+923415087197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 23, 2026