MelasmaNCT07727954
Efficacy and Safety of a Combined Topical Formula Versus Placebo in Patients With Melasma
A study testing Topical azelaic acid 12% plus tranexamic acid 5% in people with Melasma, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- Topical azelaic acid 12% plus tranexamic acid 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 12 Jun 2026to 13 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a Combined Topical Formula (Azelaic Acid and Tranexamic Acid) Versus Placebo in Patients With Melasma: Randomized, Double-blind, Controlled Clinical Trial.
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Melasma
- Being tested
- Topical azelaic acid 12% plus tranexamic acid 5%, Placebo topical formulation
- Keywords
- Melasma, Hyperpigmentation, Azelaic acid, Tranexamic acid, Placebo-controlled
- 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 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.
Placebo topical formulationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo topical formulation |
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
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.
Measured: Baseline and Week 4
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Throughout the 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start12 Jun 2026
- Primary completion10 Jul 2026
- Study completion13 Jul 2026
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 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Valdes Alvarado, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727954
- Sponsor's protocol ID
- CUCS Protocol 26-04
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no data-sharing plan was established for this investigator-initiated study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Combined Topical Formula (Azelaic Acid and Tranexamic Acid) Versus Placebo in Patients With Melasma: Randomized, Double-blind, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07727954
- Acronym / sponsor ID
- CUCS Protocol 26-04
- Conditions
- Melasma
- Keywords
- Melasma, Hyperpigmentation, Azelaic acid, Tranexamic acid, Placebo-controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 27 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Azelaic Acid + Tranexamic Acid | Experimental | Drug: Topical azelaic acid 12% plus tranexamic acid 5%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. |
| Placebo Comparator | Placebo comparator | Drug: Placebo topical formulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 12% plus tranexamic acid 5%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. | Drug | Experimental: Azelaic Acid + Tranexamic Acid |
| Placebo topical formulationMatching 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. | Drug | Placebo Comparator |
Primary outcome
Change in Melasma Area and Severity Index (MASI) score
Time frame: Baseline and Week 4
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.
3 secondary outcomes
Change in Melasma Quality of Life Scale (MELASQoL) score
Time frame: Baseline and Week 4
Change in facial pigmentation assessed by VISIA®
Time frame: Baseline and Week 4
Incidence of treatment-related adverse events
Time frame: Throughout the 4-week treatment period
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 27 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no data-sharing plan was established for this investigator-initiated study.
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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 12% plus tranexamic acid 5% in people with Melasma, run by University of Guadalajara at 1 site in Mexico.
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 6 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 27 Jul 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 Mexico. 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. Some participants in this study may receive a placebo. 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 and Week 4). 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 27 Jul 2026.