Efficacy and Safety of a Combined Topical Formula Versus Placebo in Patients With Melasma

NCT07727954 | Completed

• 1 other identifier: CUCS Protocol 26-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a topical formulation containing 12% azelaic acid and 5% tranexamic acid is effective and safe for treating melasma in adults. The main questions it aims to answer are: Does the topical formulation reduce melasma severity compared with placebo after 4 weeks of treatment? Is the topical formulation safe and well tolerated? Researchers will compare the active topical formulation with a placebo cream to determine whether the active treatment provides greater improvement in melasma severity and quality of life. Participants will: Be randomly assigned to receive either the active topical formulation or a placebo cream. Apply the assigned treatment daily for 4 weeks. Attend scheduled clinical visits for assessment of melasma severity using the Melasma Area and Severity Index (MASI), quality of life using the Melasma Quality of Life Scale (MelasQoL), and standardized facial imaging with the VISIA® skin analysis system. Be monitored for local adverse events throughout the study.

Conditions

Melasma

Keywords

Melasma; Hyperpigmentation; Azelaic acid; Tranexamic acid; Placebo-controlled

Outcome Measures

Primary Outcomes (1)

• Change in Melasma Area and Severity Index (MASI) score

  Change in the Melasma Area and Severity Index (MASI) from baseline to Week 4. MASI was assessed by the investigator to evaluate clinical severity of melasma.

  Baseline and Week 4

Secondary Outcomes (3)

• Change in Melasma Quality of Life Scale (MELASQoL) score

  Baseline and Week 4

• Change in facial pigmentation assessed by VISIA®

  Baseline and Week 4

• Incidence of treatment-related adverse events

  Throughout the 4-week treatment period

Study Arms (2)

Experimental: Azelaic Acid + Tranexamic Acid

EXPERIMENTAL

Participants received a topical formulation containing 12% azelaic acid and 5% tranexamic acid. The formulation was applied according to the study protocol for 4 weeks.

Drug: Topical azelaic acid 12% plus tranexamic acid 5%

Placebo Comparator

PLACEBO COMPARATOR

Participants received a placebo topical formulation identical in appearance and packaging to the investigational product. The placebo was applied according to the study protocol for 4 weeks.

Drug: Placebo topical formulation

Interventions

Topical azelaic acid 12% plus tranexamic acid 5% DRUG

Topical formulation containing 12% azelaic acid and 5% tranexamic acid administered for the treatment of melasma. Participants applied the assigned formulation according to the study protocol for 4 weeks.

Experimental: Azelaic Acid + Tranexamic Acid

Placebo topical formulation DRUG

Matching placebo topical formulation identical in appearance, packaging, and administration schedule to the investigational product. Participants applied the placebo according to the study protocol for 4 weeks.

Placebo Comparator

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 60 years.
• Clinical diagnosis of facial melasma.
• Fitzpatrick skin phototypes II to V.
• Willing and able to comply with all study procedures and scheduled visits.
• Willing to use sunscreen throughout the study.
• Provided written informed consent.

You may not qualify if:

• Pregnancy or breastfeeding.
• Known hypersensitivity to azelaic acid, tranexamic acid, or any component of the study formulation.
• Use of topical or systemic treatment for melasma within the previous 3 months.
• Presence of facial skin diseases or active skin infections that could interfere with study assessments.
• Participation in another clinical trial during the study period.
• Any medical condition that, in the investigator's judgment, could interfere with study participation or evaluation of the outcomes.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

The Skin Place

Tijuana, Estado de Baja California, 22010, Mexico

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigational product and placebo were prepared, coded, and labeled by personnel independent of the clinical investigators. Participants, investigators, and outcome assessors remained blinded to treatment allocation throughout the study. The treatment code was maintained separately and was not disclosed until completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Proffesor

Model Details: Participants were randomly assigned in a 1:1 ratio to receive either the investigational topical formulation containing 12% azelaic acid and 5% tranexamic acid or a matching placebo. Both groups received the assigned intervention for 4 weeks. Participants remained in their assigned treatment group throughout the study, and no crossover between groups occurred.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: June 12, 2026
• Primary Completion: July 10, 2026
• Study Completion: July 13, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)