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

NCT07732192 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Melasma
  • Melasma (Facial Melasma)

Interventions

COMBINATION_PRODUCT

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.

DRUG

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.

Sponsors & Collaborators

  • Combined Military Hospital Abbottabad

    lead OTHER

Principal Investigators

  • Ali Amar, MBBS, FCPS, CHPE · Combined Military Hospital Abbottabad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-01-14
Completion
2027-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07732192 on ClinicalTrials.gov