An interventional study of Topical Azelaic Acid 20% Cream and Topical 4% hydroquinone cream in Melasma and Melasma (Facial Melasma), sponsored by Gujranwala medical college District Headquarters Hospital, Gujranwala. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Gujranwala medical college District Headquarters Hospital, Gujranwala · Not applicable, Interventional, and Treatment
Melasma is a common skin condition that causes dark patches on the face and can significantly affect quality of life. This study compared two commonly used topical treatments, 20% azelaic acid and 4% hydroquinone, in adults with epidermal melasma.
Participants with epidermal melasma were randomly assigned to receive either azelaic acid 20% or hydroquinone 4% for a period of 12 weeks. The severity of melasma was assessed at baseline and monthly using the Melasma Area and Severity Index (MASI) score. Side effects such as irritation, redness, burning, itching, and dryness were also monitored throughout the study.
The purpose of this study was to compare the effectiveness and safety of azelaic acid and hydroquinone in reducing melasma severity and to determine whether azelaic acid can be used as a safe alternative to hydroquinone.
This randomized controlled trial was conducted in the Dermatology Department of Gujranwala Medical College Hospital, Gujranwala, from 4 May 2025 to 3 August 2025. The study was designed to compare the efficacy and safety of topical 20% azelaic acid and 4% hydroquinone in the treatment of epidermal melasma.
A total of 146 patients with clinically diagnosed epidermal melasma confirmed by Wood's lamp examination were enrolled. Patients of any age and gender were eligible. Exclusion criteria included dermal or mixed-type melasma, active skin infections, history of keloid formation, recent use of other depigmenting agents, photosensitive disorders, pregnancy or lactation, and refusal to provide written informed consent.
After obtaining informed consent, participants were randomly assigned to one of two treatment groups in a parallel design. Group A received topical azelaic acid 20%, and Group B received topical hydroquinone 4%. Participants were blinded to their treatment allocation, while treating clinicians and research staff were aware of the assigned treatment. The statistician analyzing the data was blinded to group allocation.
Both treatments were administered for a duration of 12 weeks. Participants were evaluated at baseline and then monthly. All participants were advised to use broad-spectrum sunscreen throughout the study period. Treatment compliance and adverse effects were assessed at each follow-up visit. Any adverse effects such as erythema, burning, itching, or dryness were managed with supportive care, including emollients or antihistamines if required.
The primary outcome measure was treatment efficacy, assessed by the change in Melasma Area and Severity Index (MASI) score from baseline to the end of the 12-week treatment period. Secondary outcomes included the rate of improvement over time and the safety and tolerability of both treatments.
MASI scoring was performed using a standardized method that evaluates the area of involvement, darkness, and homogeneity of melasma across four facial regions: forehead, right malar region, left malar region, and chin. Clinical photographs were also obtained to support clinical assessment.
Data were analyzed using statistical software. Quantitative variables were summarized as means and standard deviations, and qualitative variables as frequencies and percentages. Between-group comparisons of MASI scores were performed using independent-samples t-tests, with a p-value of less than 0.05 considered statistically significant.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's enrollment of 146 is above the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Gujranwala medical college District Headquarters Hospital, Gujranwala is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:- Dermal or mixed-type melasma
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects were randomised into two intervention groups of 73 each by paralel assignment . Group A (Azelaic Acid 20%) Description Group A Participants were assigned to 20%Azalic acid daily application for 12weeks as intervention for treatment of Melasma.
Drug: Topical Azelaic Acid 20% Cream
Group B (Hydroquinone 4%) Description the other grouphad also 73 participants.They were assigned to 4%Hydroquinone daily application for 12 as intervention for treatment of Melasma.
Drug: Topical 4% hydroquinone cream
Topical azelaic acid 20% cream was applied in intervention group to affected facial areas once daily for 12 weeks. The intervention is used to reduce hyperpigmentation in patients with melasma.
The other intervention isTopical application of hydroquinone 4% cream to affected facial areas once daily for 12 weeks.
Change in Melasma Area and Severity Index (MASI) Score
The primary outcome was treatment efficacy, assessed by the change in the Melasma Area and Severity Index (MASI) score from baseline to the end of the 12-week treatment period. MASI evaluates the severity of melasma based on area of involvement, darkness, and homogeneity across four facial regions.
Time frame: Baseline to 12 weeks
Plan to share: Undecided — We will do it after publication
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azelaic acid
Gujranwala medical college District Headquarters Hospital, Gujranwala