MelasmaPhase 4NCT07881328
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
A Phase 4 study testing Tranexamic acid and Standardised sunscreen and emollient in people with Melasma, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- Tranexamic acid and Standardised sunscreen and emollient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2026to Jun 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Allied Hospital-I, Department of Dermatology
Faisalabad, Punjab Province, 38000
Amara Safdar, MBBS, FCPS, +923333002797, Amara.safdar@pmc.edu.pk
About this study
Official title: Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma: A Prospective Single-Arm Study
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.
Read the detailed description
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.
- Conditions
- Melasma
- Being tested
- Tranexamic acid, Standardised sunscreen and emollient
- Keywords
- Dermoscopy, Tranexamic Acid, Vascular Phenotype, mMASI, Hyperpigmentation, Prognostic Factor
- Medical subject headings
- Melanosis, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called TXA
250 mg orally twice daily for 12 weeks, dispensed monthly.
Standardised sunscreen and emollientOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral tranexamic acid | Experimental | 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. Receives: Drug: Tranexamic acid; Other: Standardised sunscreen and emollient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 12
Secondary outcomes (6)
Change in mMASI from baseline
mMASI score (range 0-24; higher = more severe) at weeks 4, 8 and 12 compared with baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Adherence to tranexamic acid
Percentage of prescribed tablets taken, calculated from tablet counts of returned strips.
Measured: 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.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive oral tranexamic acid. The baseline dermoscopic vascular score is examined as a prognostic factor for week-12 mMASI.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amara Safdar, Allied Hospital Faisalabad
- Investigators
- Amara Safdar, MBBS, FCPS, Principal investigator, Allied Hospital, Faisalabad Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881328
- Sponsor's protocol ID
- FMU-DERM-MEL-TXA-01
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregate results will be published in a peer-reviewed journal.