An interventional study of Topical azelaic acid 12% plus tranexamic acid 5% and Placebo topical formulation in Melasma, sponsored by University of Guadalajara. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University of Guadalajara · Not applicable, Interventional, and Treatment
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.
Melasma is a chronic acquired pigmentary disorder characterized by symmetrical facial hyperpigmentation that significantly affects patients' quality of life. Although several topical therapies are available, treatment responses are often variable and recurrence is common. Azelaic acid inhibits melanogenesis through tyrosinase inhibition, whereas tranexamic acid modulates inflammatory and vascular pathways involved in melasma pathogenesis. Their complementary mechanisms suggest that combined topical administration may provide greater therapeutic benefit than either approach alone.
This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of a topical formulation containing 12% azelaic acid and 5% tranexamic acid compared with placebo in adults with melasma. Participants are randomly assigned to receive either the active formulation or placebo and are followed for four weeks. Clinical efficacy is assessed using the Melasma Area and Severity Index (MASI), patient-reported quality of life using the Melasma Quality of Life Scale (MelasQoL), and standardized facial imaging with the VISIA® skin analysis system. Safety is evaluated through the monitoring and documentation of local adverse events throughout the study.
The findings of this study are expected to provide evidence regarding the clinical efficacy, safety, and tolerability of this combined topical formulation as a potential therapeutic option for the treatment of melasma.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →University of Guadalajara is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%
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
Drug page: Azelaic acid
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.
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.
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.
Time frame: Baseline and Week 4
Change in Melasma Quality of Life Scale (MELASQoL) score
Change in patient-reported quality of life using the Melasma Quality of Life Scale (MELASQoL) from baseline to Week 4.
Time frame: Baseline and Week 4
Change in facial pigmentation assessed by VISIA®
Objective assessment of facial pigmentation using standardized VISIA® digital imaging, including evaluation of pigmentation intensity and spot count.
Time frame: Baseline and Week 4
Incidence of treatment-related adverse events
Frequency and severity of local adverse events, including erythema, pruritus, and burning sensations, recorded throughout the study.
Time frame: Throughout the 4-week treatment period
Plan to share: No — Individual participant data will not be shared because no data-sharing plan was established for this investigator-initiated study.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Azelaic acid
University of Guadalajara