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NCT07881328
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
Conditions: Melasma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 128
Sponsor: Allied Hospital Faisalabad
Location: Allied Hospital-I, Department of Dermatology Faisalabad Punjab Province
Summary
Melasma is a common, long-lasting pigmentation disorder of the face. Some patients improve well with treatment and others improve little, and there is no simple way to predict this at the first visit. Recent studies suggest that melasma with more visible blood-vessel involvement may respond less well to treatment.
This study will assess whether the amount of vascular involvement seen on dermoscopy before treatment is associated with melasma severity after 12 weeks of oral tranexamic acid.
Adults with facial melasma (Fitzpatrick skin types III-V) attending the Department of Dermatology, Allied Hospital-I, Faisalabad, will take oral tranexamic acid 250 mg twice daily for 12 weeks, with a standard sunscreen and a plain moisturiser. Melasma severity (mMASI) will be scored at baseline and at weeks 4, 8 and 12. A dermoscopic vascular score will be recorded at baseline and week 12.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or above, either sex
* Clinically diagnosed facial melasma
* Fitzpatrick skin type III, IV or V
* Baseline mMASI of 4 or greater
* Treatment-naive, or no topical or systemic melasma treatment for at least 2 weeks
* Willing to take oral tranexamic acid and attend all follow-up visits
* Written informed consent
Exclusion Criteria:
* Pregnancy, lactation or planned pregnancy during the study
* History of deep venous thrombosis, pulmonary embolism, stroke, myocardial infarction or other significant thromboembolic disease
* Known thrombophilia or coagulation disorder, or clinically relevant family history
* Current oestrogen-containing contraceptive or other oestrogen-containing treatment
* Current anticoagulant treatment
* Renal impairment or serum creatinine above the reference range
* Active malignancy, or major surgery within 3 months
* Known hypersensitivity to tranexamic acid
* Other facial pigmentary disorder that may interfere with assessment (exogenous ochronosis, lichen planus pigmentosus, acquired dermal macular hyperpigmentation, prominent post-inflammatory hyperpigmentation)
* Active rosacea, facial eczema, inflammatory acne or other facial inflammatory dermatosis
* Dermoscopic vascularity ungradable in two or more affected facial regions
* Chemical peel, microneedling, laser or other procedural melasma treatment within 3 months
* Any other contraindication to oral tranexamic acid
Source: ClinicalTrials.gov (NCT07881328). StuddyBuddy aggregates publicly available trial information.