MelasmaNCT07327983
Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma
A study testing Topical Azelaic Acid 20% Cream and Topical 4% hydroquinone cream in people with Melasma and Melasma (Facial Melasma), run by Gujranwala medical college District Headquarters Hospital, Gujranwala at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melasma, Melasma (Facial Melasma)
- What is being tested?
- Topical Azelaic Acid 20% Cream and Topical 4% hydroquinone cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 sitePakistan
- Study dates
- 4 May 2025to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with clinically diagnosed epidermal melasma confirmed by Wood's lamp examination
- Male or female participants of any age
- Willingness to provide written informed consent
- Ability to comply with study procedures and follow-up visits
Who cannot join
- Active cutaneous or facial skin infection
- History of keloid formation
- Recent use of other topical or systemic depigmenting agents
- Presence of photosensitive disorders
- Pregnancy or lactation
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gujranwala Medical College Hospital
Lahore, Punjab Province, +92
About this study
Official title: Topical 20% Azelaic Acid Versus 4% Hydroquinone in Epidermal Melasma: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Melasma, Melasma (Facial Melasma)
- Being tested
- Topical Azelaic Acid 20% Cream, Topical 4% hydroquinone cream
- Keywords
- Melasma, Azelaic Acid, Hydroquinone, Topical Therapy, Hyperpigmentation, Comparative Study, Dermatology
- Medical subject headings
- Melanosis, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Azelaic Acid 20% CreamDrug
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.
Topical 4% hydroquinone creamDrug
The other intervention isTopical application of hydroquinone 4% cream to affected facial areas once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GroupA | Experimental | 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. Receives: Drug: Topical Azelaic Acid 20% Cream |
| GroupB | Active comparator | 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. Receives: Drug: Topical 4% hydroquinone cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start4 May 2025
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
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
- Model description
- Participants were randomly assigned to one of two parallel groups to receive either topical 20% azelaic acid or topical 4% hydroquinone for 12 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gujranwala medical college District Headquarters Hospital, Gujranwala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasan Saaqib, Gujranwala medical college District Headquarters Hospital, Gujranwala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327983
- Sponsor's protocol ID
- IRB.23/GMC
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will do it after publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 20% Azelaic Acid Versus 4% Hydroquinone in Epidermal Melasma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07327983
- Acronym / sponsor ID
- IRB.23/GMC
- Conditions
- Melasma, Melasma (Facial Melasma)
- Keywords
- Melasma, Azelaic Acid, Hydroquinone, Topical Therapy, Hyperpigmentation, Comparative Study, Dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Gujranwala medical college District Headquarters Hospital, GujranwalaUniversity, hospital or other
- Study start
- 4 May 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 8 Jan 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups to receive either topical 20% azelaic acid or topical 4% hydroquinone for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| GroupA | Experimental | Drug: Topical Azelaic Acid 20% CreamSubjects 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. |
| GroupB | Active comparator | Drug: Topical 4% hydroquinone creamGroup 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinically diagnosed epidermal melasma confirmed by Wood's lamp examination
- Male or female participants of any age
- Willingness to provide written informed consent
- Ability to comply with study procedures and follow-up visits
Key exclusion criteria (6 listed)
- Active cutaneous or facial skin infection
- History of keloid formation
- Recent use of other topical or systemic depigmenting agents
- Presence of photosensitive disorders
- Pregnancy or lactation
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 |
|---|---|---|
| Topical Azelaic Acid 20% CreamTopical 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. | Drug | GroupA |
| Topical 4% hydroquinone creamThe other intervention isTopical application of hydroquinone 4% cream to affected facial areas once daily for 12 weeks. | Drug | GroupB |
Primary outcome
Change in Melasma Area and Severity Index (MASI) Score
Time frame: Baseline to 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided. We will do it after publication
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Azelaic Acid 20% Cream and Topical 4% hydroquinone cream in people with Melasma and Melasma (Facial Melasma), run by Gujranwala medical college District Headquarters Hospital, Gujranwala 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Melasma Area and Severity Index (MASI) Score (time frame: Baseline to 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 8 Jan 2026.