A Phase 4 interventional study of Tranexamic acid and Standardised sunscreen and emollient in Melasma, sponsored by Allied Hospital Faisalabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Allied Hospital Faisalabad · Phase 4, Interventional, and Treatment
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.
Design: prospective, single-centre, single-arm interventional study with prognostic-factor assessment.
Exposure: a study-defined dermoscopic vascular score. In each affected facial region (forehead, right malar, left malar, chin), one field in the most densely pigmented area is graded 0-3 for erythema and telangiectatic vessels, giving a total of 0-12 (prorated when fewer than four regions are graded). Dermoscopy uses a DermLite DL4 in polarised contact mode with minimal or no pressure, after removal of cosmetics and sunscreen and a 5-minute rest.
Outcome assessment: mMASI is scored at every visit by a dermatologist unaware of the vascular score; at baseline and week 12 it is completed before dermoscopy.
Sample size: precision-based. 102 participants with complete data give a 95% confidence interval of total width 0.40 for the adjusted correlation; 128 will be recruited to allow 20% non-evaluability.
Analysis: multiple linear regression of week-12 mMASI on baseline vascular score, adjusted for baseline mMASI, duration of melasma, age and Fitzpatrick skin type. Missing week-12 outcomes will be handled by multiple imputation, with prespecified sensitivity analyses, including adjustment for prior topical corticosteroid use. Inter-observer reliability will be assessed by intraclass correlation on stored baseline images of the first 40 participants.
Safety: participants are screened for thromboembolic risk and given written stop-and-attend instructions. Rescue treatment is offered if mMASI rises by 25% or more above baseline. Serious adverse events are reported to the Ethical Review Committee.
159 studies on the registry are indexed under Melanosis; 42 are open to participants now.
This study's planned enrollment of 128 is above the median of 40 across 149 interventional studies indexed under Melanosis.
Browse Melanosis studies →Allied Hospital Faisalabad is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Oral tranexamic acid 250 mg twice daily for 12 weeks, with the same broad-spectrum SPF 50+ sunscreen and the same plain ceramide-based emollient, neither containing any depigmenting ingredient. No other depigmenting treatment is permitted during the study.
Drug: Tranexamic acid · Other: Standardised sunscreen and emollient
250 mg orally twice daily for 12 weeks, dispensed monthly.
Also known as: TXA
Broad-spectrum SPF 50+ sunscreen each morning and reapplied during the day; plain ceramide-based emollient at night. Both are free of depigmenting or brightening agents.
Week-12 mMASI in relation to baseline dermoscopic vascular score
Association between the baseline dermoscopic vascular score (range 0-12; higher = more vascular) and the modified Melasma Area and Severity Index (mMASI; range 0-24; higher = more severe) at week 12. Estimated by multiple linear regression adjusted for baseline mMASI, duration of melasma, age and Fitzpatrick skin type, and reported as the adjusted difference in week-12 mMASI per one-point higher baseline vascular score.
Time frame: Baseline and week 12
Change in mMASI from baseline
mMASI score (range 0-24; higher = more severe) at weeks 4, 8 and 12 compared with baseline.
Time frame: Baseline, weeks 4, 8 and 12
Percentage reduction in mMASI and proportion of responders
Change in total dermoscopic vascular score (range 0-12) from baseline to week 12 in matched facial regions, and its association with absolute change in mMASI.
Time frame: Baseline and week 12
Treatment response by dermoscopic phenotype
Exploratory descriptive comparison of week-12 mMASI response between pigmentary (vascular score below 4) and pigmentary-vascular (vascular score 4 or more) phenotypes.
Time frame: Week 12
Inter-observer reliability of the dermoscopic vascular score
Intraclass correlation coefficient (two-way mixed effects, absolute agreement, single measure) between two dermatologists independently scoring stored baseline dermoscopic images of the first 40 participants.
Time frame: Baseline
Adherence to tranexamic acid
Percentage of prescribed tablets taken, calculated from tablet counts of returned strips.
Time frame: Weeks 4, 8 and 12
Adverse events, treatment discontinuation and rescue treatment
Number of participants with adverse events (including thromboembolic events), number discontinuing treatment, and number receiving rescue treatment.
Time frame: Baseline to week 12
Plan to share: No — Individual participant data will not be shared. Aggregate results will be published in a peer-reviewed journal.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tranexamic Acid
Allied Hospital Faisalabad