MelasmaNCT07890571
COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
A study testing Ascorbic acid and niacinamide in people with Melasma, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Melasma
- What is being tested?
- Ascorbic acid and niacinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 46000
Dr Bilal azhar, MBBS, +923441713236, bilalaxhar786@gmail.com
About this study
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.
Read the 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.
- Conditions
- Melasma
- Being tested
- Ascorbic acid, niacinamide
- Keywords
- Melasma Vitamin C Niacinamide Topical treatment Hyperpigmentation Randomized controlled trial Comparative efficacy Facial pigmentation
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Also called ascorbic acid 10 %
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.
niacinamideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Topical 10 % vitamin C GROUP | Experimental | Not described Receives: Drug: Ascorbic acid |
| Arm 2: Topical 10% niacinamide group | Experimental | Not described Receives: Drug: niacinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to the end of the treatment period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hasnain Abbas, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890571
- Sponsor's protocol ID
- PEMH-DERM-2026-001
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participation data will not be shared with other researhers.Only aggregates study results may be published while maintaining participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
- ClinicalTrials.gov ID
- NCT07890571
- Acronym / sponsor ID
- PEMH-DERM-2026-001
- Conditions
- Melasma
- Keywords
- Melasma Vitamin C Niacinamide Topical treatment Hyperpigmentation Randomized controlled trial Comparative efficacy Facial pigmentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Topical 10 % vitamin C GROUP | Experimental | Drug: Ascorbic acid |
| Arm 2: Topical 10% niacinamide group | Experimental | Drug: niacinamide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic acidAlso: ascorbic acid 10 %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. | Drug | Arm 1: Topical 10 % vitamin C GROUP |
| niacinamideparticipants 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. | Drug | Arm 2: Topical 10% niacinamide group |
Primary outcome
change in MASI score
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. individual participation data will not be shared with other researhers.Only aggregates study results may be published while maintaining participant confidentiality.
Related trials for Melasma
Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
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Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruiting
New Treatment in Melasma
Female, With
Not yet recruitingPhase 4
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
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Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser
Melasma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic acid and niacinamide in people with Melasma, run by Pak Emirates Military Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Hasnain Abbas, MBBS/FCPS Dermatology Resident (+923415087197, drhasnain12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in MASI score (time frame: Baseline to the end of the treatment period (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.