About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)
Combination productParticipants will receive oral tranexamic acid in combination with topical triple combination cream (fluocinolone acetonide, hydroquinone, and tretinoin) for the treatment of melasma. The efficacy and safety of this combined therapy will be evaluated and compared with triple combination cream alone.
Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone
DrugParticipants will receive topical triple combination cream containing fluocinolone acetonide, hydroquinone, and tretinoin alone as standard therapy for the treatment of melasma. Its efficacy and safety will be compared with the combination therapy including oral tranexamic acid.
Treatment groups
Trial outcomes
Primary outcomes
MASI Score
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of treatment period.
Locations
Sponsors and contacts
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