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Trial record 51 of 419 for:    TRANEXAMIC ACID

Oral and Topical Tranexamic Acid for the Treatment of Melasma (TRANEXAMICO)

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ClinicalTrials.gov Identifier: NCT03585179
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Centro Dermatológico Dr. Ladislao de la Pascua

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.

Condition or disease Intervention/treatment Phase
Melasma Chloasma Melanosis Drug: Oral Tranexamic Acid Drug: 5% topical tranexamic acid Drug: 4% hydroquinone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-arm clinical trial
Masking: Triple (Participant, 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral tranexamic acid
250 mg of tranexamic acid bid orally
Drug: Oral Tranexamic Acid
Participants will take a pill of 250 mg bid for 12 weeks

Experimental: Topical tranexamic acid
5% topical tranexamic acid bid
Drug: 5% topical tranexamic acid
Participants will apply a layer of gel on the affected skin bid for 12 weeks
Other Name: Topical tranexamic acid

Active Comparator: Topical hydroquinone
4% hydroquinone once daily at night
Drug: 4% hydroquinone
Participants will apply a layer of cream on the affected skin once at night
Other Name: Hydroquinone




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Quality of life [ Time Frame: 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.

  2. Melanin index [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585179


Contacts
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Contact: Martha A Morales-Sánchez, MD 55387033 ext 312 mmoraless@sersalud.df.gob.mx

Locations
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Mexico
Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, Mexico, 06780
Sponsors and Collaborators
Centro Dermatológico Dr. Ladislao de la Pascua
Investigators
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Study Director: Martha A Morales-Sánchez, MD Centro Dermatológico Dr. Ladislao de la Pascua

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Responsible Party: Centro Dermatológico Dr. Ladislao de la Pascua
ClinicalTrials.gov Identifier: NCT03585179     History of Changes
Other Study ID Numbers: 151/2018
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only if researchers ask for the complete data of the trial.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Centro Dermatológico Dr. Ladislao de la Pascua:
Melasma
Chloasma
Melanosis
Tranexamic acid
Hydroquinone
Therapeutics
Additional relevant MeSH terms:
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Tranexamic Acid
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Hydroquinone
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Antioxidants
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents