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

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)
  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.
• Препарат Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone
  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.

Первичные конечные точки

• MASI Score [Срок оценки: 6 months]

Критерии участия

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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07732192 · CMH-Atd-ETH-234-Derma-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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