Oral Tranexamic Acid Plus Triple Combination vs Triple Combination Alone in Melasma

Starting soon · Phase 4

Conditions studied: Melasma, Melasma (Facial Melasma)

In brief

The data will be collected after the permission of the ethical committee of hospital. Following the enrollment, patients will be selected by lottery in the two equal groups. Group A will be administered with oral tranexamic acid and triple combination therapy whereas Group B will be treated with triple combination therapy. Strict use of sunscreens and sun protection will be promoted to all patients. Group A will administer oral tranexamic acid with the prescribed dose of the study drug along with topical application of fluocinolone acetonide, hydroquinone and tretinoin at bedtime. Group B will be treated by triple combination therapy only once a day at night. The study will continue to treatment. There will be a baseline MASI score which will be taken prior to the onset of treatment and re-evaluated at the planned follow-ups. The main outcome will be the decrease in the MASI score and the percentage of the patients who will be responding to treatment. The negative effects and recurrence in the follow-up will be considered as secondary outcomes. The structured proforma will gather data on age, gender, melasma duration, skin phototype, baseline MASI score, treatment group, follow-up MASI score, percentage improvement, adverse effects and treatment response. The principal investigator will document all the findings.

Key facts

Study ID

NCT07732192

Run by

Combined Military Hospital Abbottabad

People needed

128

Starts

2026-07-15

Expected to finish

2027-02-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

Full record on ClinicalTrials.gov

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