A split-face, double-blind, randomized controlled trial of Tixel with and without application of tranexamic acid in melasma patients: a pilot study
- Conditions
- Melasma in Thai womentransdermal tranexamic acid delivery for treatment of melasma
- Registration Number
- TCTR20171223003
- Lead Sponsor
- Division of Dermatology, Department of Medicine, Faculty of Medicine, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 20
1. Female age 18-60 years
2. No underlying medical condition
3. Having similar melasma lesions on both sides of face
4. Not allergy to tranexamic acid
5. NO history of photosensitivity or heat intolerance
6. Capacity and agreement to comply to treatment and follow up protocol
7.Capacity to give written informed consent
1. Pregnancy and breast feeding
2. Taking hormonal drugs or birth control pills within 1 year before treatment
3. Having light and laser treatment within 6 months before treatment
4. Using topical drugs for melasma or depigmented agents within 1 month before treament
5. Having rash or abnormal skin condition on face
6. Having cancer, hematologic disease, severe allergy, or serious systemic disease
7. Unwilling to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative lightness index (RLI) weeks 4, 8, 12, 16 Relative lightness index (RLI) = L normal skin - L Melasma
- Secondary Outcome Measures
Name Time Method Modified MASI score weeks 4, 8, 12, 16 mMASI = (darkness of pigment + homogeneity) x area