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To study the efficacy of oral tranexamic acid in treatment of melasma

A prospective, interventional, double- blind randomized controlled study of efficacy of oral tranexamic acid in patients with facial melasma - TXA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/008955
Enrollment
130
Registered
2017-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Facial Melasma

Interventions

Intervention1: tab . Tranexamic acid: Tranexamic acid (trans-4-aminomethylcyclohexanecarboxylic acid: TXA) is a synthetic lysine analog which has an antifibrinolytic effect through the reversible bloc

Sponsors

KJSomaiya medical college and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. To determine whether oral TXA (250 mg bid) + routine topical treatment is superior to routine topical therapy alone for facial melasma. 2. To evaluate the efficacy of oral TXA as an adjuvant in patients with facial melasma. Timepoint: Baseline vs Week 4 Week 8 Week 12 Week 24

Secondary

MeasureTime frame
oral tranexamic acid 250mg bd as adjuvant in treatment of melasma Side effect profile of oral tranexamic acidTimepoint: treatment for 3 months follow up for next 3 months

Countries

India

Contacts

Public ContactDr Khushboo Minni

K.J.Somaiya hospital and medical research centre

spoojary2004@gmail.com02224090253

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026