Not Yet RecruitingPhase 2ACTRN12616000548437

Treatment of Melasma with Oral Tranexamic Acid

Randomised efficacy study of oral tranexamic acid for the treatment of moderate to severe melasma in adult females.

Sponsor

Dr Michelle Rodrigues

Enrollment

44 participants

Start Date

May 28, 2016

Study Type

Interventional

Conditions

Melasma

Summary

Melasma is a common disorder of hyperpigmentation, primarily affecting the face. It can affect all racial types but predominately affects women with darker skin types. The exact cause of melasma is unknown, but it is thought to be due to many things including pregnancy, hormonal contraception, and sunlight. Melasma can be very difficult to treat and often frustrating for the participant and doctor with evidence showing that it may adversely affect quality of life. Over the past decade, there has been growing use of topical, oral and injectable TXA in Asia. More recently, clinical research in Asia has shown promising results with oral tranexamic acid for the treatment of melasma. The dose used in melasma is less than that for menorrhagia. Typically 500-750mg daily is used for melasma. Despite promising results with oral TXA for the treatment of melasma in Asian studies, none have been conducted in the western world to date. You will be asked to come for 6 study visits. An initial screening visit will be followed (if you qualify for the study) by a review at weeks 0, 4, 8, 12 and 24. You will be randomly allocated into one of 2 arms. In the TXA group, participants will take two 250 mg tablet (this will be a 500mg tablet that will be broken into a half). This will be taken daily for 12 weeks from the baseline visit. Participants in the placebo arm will follow an identical protocol with placebo capsule, which does not contain the active medication. All participants will use sunscreen to the entire face during the day. After week 12 participants will stop taking the medication and continue sunscreen for an additional 12 weeks. The researchers will be providing all participants with a standard sunscreen of at least SPF 30. Participants will be instructed not to use any other medications for melasma during the study period. Although no adverse effects have been reported with TXA in pregnancy and no theoretical basis of risk exists, it has not been formally studied in pregnant women. Therefore, we requested to avoid becoming pregnant and use non-hormonal contraceptive methods during the study if you are sexually active. If pregnancy occurs please discontinue the study medication and inform the study investigators if pregnancy occurs. This study aims to determine how effective oral tranexamic is for melasma and also assess its safety.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial (ACTRN12616000548437) is studying: Treatment of Melasma with Oral Tranexamic Acid. Researchers are looking for volunteers who are between 18 years and 80 years old. This study is open to female participants only. You may be eligible if: - Must provide informed consent - Must be between the age of 18-80 and female - Female of child bearing potential must have a negative pregnancy test at screening and Day 1 and be using an effective method of contraception until 28 days after taking the last dose of the study drug. Acceptable methods of contraception include, but are not limited to the following methods; mon... - Females of non-childbearing potential as determined by having undergone of the following procedures - a. Sterilisation - b. Bilateral tubal ligation - c. Hysterectomy - d. Bilateral oophorectomy You may NOT be eligible if: - Females who are pregnant or nursing, or women who are planning a pregnancy during the study - Women on hormonal birth control - Current treatment with blood thinning medications - Use of topical hydroquinone within 3 months of study enrolment - Use of topical steroids or vitamin A analogues within 1 month of study enrolment - History of laser or any mechanically abrading treatments to the face within 9 months of study enrolment - Regular use of tanning parlours, or occupation involving primarily outdoor activities - Additional exclusion criteria based on the TGA-approved package insert for TXA are: Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Tranexamic acid is formulated as a tablet containing microcrystalline cellulose, purified talc, magnesium stearate, anhydrous colloidal silica, povidone, hydroxypropylcellulose, titanium dioxide, macrogol 8000, vanillin and the proprietary ingredient, Eudragit E100 (ID number 1753). Presentation: Capsules, 250 mg: 60's (HDPE bottle) For the purpose of this study, capsules containing 250mg of TXA will be used. 500mg TXA tablet will be halved, crushed and put into a capsule size 1 to contain 250mg of TXA. The compounding will be done via Novo Pharmacy Forrest Hill. Treatment group: TXA 250mg twice daily, orally for 12 weeks. All patients will use sunscreen once daily to the entire face during the day. After week 12 they will stop taking the capsule and continue sunscreen for an additional 12 weeks. We will be providing all subjects with a standard sunscreen of at least SPF 30. To monitor capsule adherence patients will be issued a fixed number of capsules between each study visits. Remaining study drug will be counted and new study drug will be dispensed if required with instructions to take TXA at the same time everyday to encourage compliance To monitor sunscreen usage adherence, weight of sunscreen bottle will be weighed at each visit. 3g (3ml) of sunscreen should be used on the face daily