Melasma, Chloasma, Melanosis
Conditions
Keywords
Melasma, Chloasma, Melanosis, Tranexamic acid, Hydroquinone, Therapeutics
Brief 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. 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.
Interventions
Participants will take a pill of 250 mg bid for 12 weeks
DRUG5% topical tranexamic acid
Participants will apply a layer of gel on the affected skin bid for 12 weeks
DRUG4% hydroquinone
Participants will apply a layer of cream on the affected skin once at night
Sponsors
Centro Dermatológico Dr. Ladislao de la Pascua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will receive both topical and oral interventions. Group 1: pills of tranexamic acid 250 mg bid plus placebo gel bid, Group 2: pills of placebo bid plus 5% tranexamic acid gel bid and Group 3: pills of placebo bid plus 4% hydroquinone cream at night and a placebo cream at morning. Containers will be of identical appearance.
Intervention model description
Three-arm clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of mMASI (Modified Melasma Area and Severity Index) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life | 12 weeks | 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. |
| Melanin index | 12 weeks | 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. |
Countries
Mexico
Contacts
Primary ContactMartha A Morales-Sánchez, MD
Outcome results
None listed