MelasmaPhase 3TRANEXAMICONCT03585179
Oral and Topical Tranexamic Acid for the Treatment of Melasma
A Phase 3 study testing Oral Tranexamic Acid, 5% topical tranexamic acid and 4% hydroquinone in people with Melasma and Chloasma, run by Centro Dermatológico Dr. Ladislao de la Pascua at 1 site in Mexico.
Trial summary
Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Oral Tranexamic Acid, 5% topical tranexamic acid and 4% hydroquinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2018to 1 Jun 2020
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age older than 18 years
- Moderate to severe melasma
- History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI <50% reported by the dermatologist after one year of treatment.
Who cannot join
- Pregnancy
- Hormonal contraception
- Lactation
- Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months
- Endocrinology diseases
- Hormone replacement therapy
- Family or personal history of one of the following: autoimmune disorders, coagulation disorders, chronic venous insufficiency, heart diseases, retinopathies, kidney disorders
- Mental disability
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, 06780
About this study
Official title: Oral and 5% Topical Tranexamic Acid in Monotherapy Compared With 4% Topical Hydroquinone for the Treatment of Melasma: Three-arm Randomized, Double-blinded Clinical Trial
Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.
Read the detailed description
Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. One hundred and twenty patients will be recruited in 3 groups of intervention: group I with tranexamic acid at a dose of 250 mg bid orally, group II with 5% topical tranexamic acid bid, group III with 4% topical hydroquinone once daily. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.
- Being tested
- Oral Tranexamic Acid, 5% topical tranexamic acid, 4% hydroquinone
- Keywords
- Melasma, Chloasma, Melanosis, Tranexamic acid, Hydroquinone, Therapeutics
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Tranexamic AcidDrug
Participants will take a pill of 250 mg bid for 12 weeks
5% topical tranexamic acidDrug
Also called Topical tranexamic acid
Participants will apply a layer of gel on the affected skin bid for 12 weeks
4% hydroquinoneDrug
Also called Hydroquinone
Participants will apply a layer of cream on the affected skin once at night
| Study group | Role | What they receive |
|---|---|---|
| Oral tranexamic acid | Experimental | 250 mg of tranexamic acid bid orally Receives: Drug: Oral Tranexamic Acid |
| Topical tranexamic acid | Experimental | 5% topical tranexamic acid bid Receives: Drug: 5% topical tranexamic acid |
| Topical hydroquinone | Active comparator | 4% hydroquinone once daily at night Receives: Drug: 4% hydroquinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mMASI (Modified Melasma Area and Severity Index)
The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12
Measured: 12 weeks
Secondary outcomes (2)
Change in Quality of life
The reported change of the score of DLQI (Dermatology Life Quality Index) at week 0 versus week 12. Total score ranges from 0 to 30 and the difference between the score at week 0 and week 12 will be calculated.
Measured: 12 weeks
Melanin index
The difference between melanin index at week 0 versus week 12. The melanin index will be measure with Mexameter® MX 18. Total index ranges from 0 to 999.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha A Morales-Sánchez, MD, Study director, Centro Dermatológico Dr. Ladislao de la Pascua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585179
- Sponsor's protocol ID
- 151/2018
- Acronym
- TRANEXAMICO
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only if researchers ask for the complete data of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and 5% Topical Tranexamic Acid in Monotherapy Compared With 4% Topical Hydroquinone for the Treatment of Melasma: Three-arm Randomized, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03585179
- Acronym / sponsor ID
- TRANEXAMICO / 151/2018
- Keywords
- Melasma, Chloasma, Melanosis, Tranexamic acid, Hydroquinone, Therapeutics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la PascuaUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 12 Jul 2018 (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.
Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.
Detailed description
Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. One hundred and twenty patients will be recruited in 3 groups of intervention: group I with tranexamic acid at a dose of 250 mg bid orally, group II with 5% topical tranexamic acid bid, group III with 4% topical hydroquinone once daily. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Oral tranexamic acid | Experimental | Drug: Oral Tranexamic Acid250 mg of tranexamic acid bid orally |
| Topical tranexamic acid | Experimental | Drug: 5% topical tranexamic acid5% topical tranexamic acid bid |
| Topical hydroquinone | Active comparator | Drug: 4% hydroquinone4% hydroquinone once daily at night |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age older than 18 years
- Moderate to severe melasma
- History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI <50% reported by the dermatologist after one year of treatment.
Key exclusion criteria (8 listed)
- Pregnancy
- Hormonal contraception
- Lactation
- Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months
- Endocrinology diseases
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 |
|---|---|---|
| Oral Tranexamic AcidParticipants will take a pill of 250 mg bid for 12 weeks | Drug | Oral tranexamic acid |
| 5% topical tranexamic acidAlso: Topical tranexamic acidParticipants will apply a layer of gel on the affected skin bid for 12 weeks | Drug | Topical tranexamic acid |
| 4% hydroquinoneAlso: HydroquinoneParticipants will apply a layer of cream on the affected skin once at night | Drug | Topical hydroquinone |
Primary outcome
Change of mMASI (Modified Melasma Area and Severity Index)
Time frame: 12 weeks
The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12
2 secondary outcomes
Change in Quality of life
Time frame: 12 weeks
Melanin index
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: No. Only if researchers ask for the complete data of the trial.
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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.
Martha A Morales-Sánchez, MD study director
Centro Dermatológico Dr. Ladislao de la Pascua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Tranexamic Acid, 5% topical tranexamic acid and 4% hydroquinone in people with Melasma and Chloasma, run by Centro Dermatológico Dr. Ladislao de la Pascua 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Jul 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha A Morales-Sánchez, MD (55387033 ext. 312, mmoraless@sersalud.df.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mMASI (Modified Melasma Area and Severity Index) (time frame: 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 16 Jul 2018.