To study the efficacy of oral tranexamic acid in treatment of melasma
- Conditions
- Health Condition 1: null- Facial Melasma
- Registration Number
- CTRI/2017/07/008955
- Lead Sponsor
- KJSomaiya medical college and research centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 130
All consenting male and female patients diagnosed clinically with melasma being defined as having acquired hyperpigmentation on the face, irregular light to gray brown macules or patches located on sunâ??exposed skin commonly affecting the cheeks, forehead, upper lip, nose and chin symmetrically attending the out-patient clinic at Department of Dermatology, Venereology and Leprosy of our tertiary care hospital.
b)Age > 18 years
c)Absence of other confounding inflammatory dermatoses (eg. Exogenous ochronosis, Acanthosis nigricans, post inflammatory hyperpigmentation, Pigmented cosmetic dermatitis, Actinic lichen planus, malar rash, etc.)
EXCLUSION CRITERIA:
a)Patients with melasma on neck and/or forearms attending the out-patient clinic at the Department of Dermatology, Venereology and Leprosy.
b)Pregnancy and lactation,
c)Any chronic medical illness,
d)History of thrombosis, abnormal bleeding profile,
e)Any medical treatment for melasma within 1 month of entry,
f)Skin resurfacing by dermabrasion, chemical peels, and facial laser within the preceding 9 months,
g)Hypersensitivity to TXA,
h)Abnormal bleeding time, clotting time or platelet count
i)History suggestive of Acquired defective colour vision
j)Refusal to allow photographs and
k)Failure to finish the whole period of study would be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine whether oral TXA (250 mg bid) + routine topical treatment is superior to routine topical therapy alone for facial melasma. <br/ ><br>2. To evaluate the efficacy of oral TXA as an adjuvant in patients with facial melasma. <br/ ><br>Timepoint: Baseline vs <br/ ><br>Week 4 <br/ ><br>Week 8 <br/ ><br>Week 12 <br/ ><br>Week 24
- Secondary Outcome Measures
Name Time Method oral tranexamic acid 250mg bd as adjuvant in treatment of melasma <br/ ><br>Side effect profile of oral tranexamic acidTimepoint: treatment for 3 months <br/ ><br>follow up for next 3 months