ACTRN12616000548437Not yet recruitingPhase 2
Randomised efficacy study of oral tranexamic acid for the treatment of moderate to severe melasma in adult females.
Dr Michelle Rodrigues0 sites44 target enrollmentStarted: April 28, 2016Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 44
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- Female
Inclusion Criteria
- •1.Must provide informed consent
- •2.Must be between the age of 18-80 and female
- •3.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; monogamous relationship with vasectomized partner, or barrier methods
- •4.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
- •e.Or be postmenopausal with amenorrhea for at least 1 year prior to screening
- •5.Moderate to severe melasma defined by the following at screening visit:
- •a.Modified MASI scoring
- •b.Mexameter readings
- •6.Willing and able to comply with study instructions and return to the study site for required visits
- •7.Must be able to comply with the study regimen for the duration of the study
Exclusion Criteria
- •1.Females who are pregnant or nursing, or women who are planning a pregnancy during the study
- •2.Women on hormonal birth control
- •3.Current treatment with blood thinning medications
- •4.Use of topical hydroquinone within 3 months of study enrolment
- •5.Use of topical steroids or vitamin A analogues within 1 month of study enrolment
- •6.History of laser or any mechanically abrading treatments to the face within 9 months of study enrolment
- •7.Regular use of tanning parlours, or occupation involving primarily outdoor activities
- •8.Additional exclusion criteria based on the TGA-approved package insert for TXA are:
- •a.history of thrombosis or thrombophilia
- •c.>2 spontaneous abortions
- •d.significant kidney dysfunction (creatinine clearance less than 40mls/min)
- •f.smoking (>8 cigarettes per year)
- •g.significant cardiovascular or respiratory disease (end stage congestive heart failure or chronic obstructive pulmonary disease)
- •h.subarachnoid hemorrhage
- •i.acquired disturbances of color vision
- •j.active thromboembolic disease such as deep vein thrombosis (DVT)
- •k.pulmonary embolism
- •l.cerebral thrombosis.
- •m.those who will be travelling long distances (car, train, ship or plane travel) anytime during the study period will be excluded from the study.
- •n.those on hormonal replacement therapy (HRT) due to increased risk of thrombosis
Investigators
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