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NCT Number: NCT07732192

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged 18 to 50 years of either gender with clinically diagnosed epidermal or mixed melasma of at least six months duration and baseline MASI score above the predefined threshold will be included. Patients willing to comply with treatment and follow-up schedule will be enrolled.

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Exclusion criteria

Patients with dermal melasma, pregnancy, lactation, history of thromboembolic disease, coagulation disorders, current hormonal therapy use, recent treatment for melasma, hypersensitivity to study medications, or significant hepatic or renal disease will be excluded.

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Treatment and study plan

Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)

Combination Product

Participants 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

Drug

Participants 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.

Primary outcomes

  1. MASI Score

    Time frame: 6 months

    Change in Melasma Area and Severity Index (MASI) score from baseline to the end of treatment period.

Study contacts

Contact information is provided by the study sponsor or research team.

Kiran Nawaz Jadoon, MBBS

CONTACT

[email protected]

+923345806838

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Official study title

Comparative Efficacy of Oral Tranexamic Acid With Triple Combination (Fluocinolone+ Hydroquinone +Tretinoin) Versus Triple Combination Alone in Melasma in a Tertiary Care Hospital

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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