Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma

NCT07327983 | Completed

• 1 other identifier: IRB.23/GMC
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Melasma; Melasma (Facial Melasma)

Keywords

Melasma; Azelaic Acid; Hydroquinone; Topical Therapy; Hyperpigmentation; Comparative Study; Dermatology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 weeks

Study Arms (2)

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.

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.

Drug: Topical 4% hydroquinone cream

Interventions

Topical Azelaic Acid 20% Cream DRUG

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.

GroupA

Topical 4% hydroquinone cream DRUG

The other intervention isTopical application of hydroquinone 4% cream to affected facial areas once daily for 12 weeks.

GroupB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gujranwala medical college District Headquarters Hospital, Gujranwala: lead

Study Sites (1)

Gujranwala Medical College Hospital

Lahore, Punjab Province, +92, Pakistan

Location

MeSH Terms

Conditions

Melanosis; Hyperpigmentation

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to treatment allocation. Treating clinicians and study staff were aware of group assignments. The statistician analyzing the data received coded datasets and was blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 5th year resident

Model Details: Participants were randomly assigned to one of two parallel groups to receive either topical 20% azelaic acid or topical 4% hydroquinone for 12 weeks.

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: May 4, 2025
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

PA (1)