Oral Tranexamic Acid Plus Triple Combination vs Triple Combination Alone in Melasma
Comparative Efficacy of Oral Tranexamic Acid With Triple Combination (Fluocinolone+ Hydroquinone +Tretinoin) Versus Triple Combination Alone in Melasma in a Tertiary Care Hospital
1 other identifier
interventional
128
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2026
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2026
CompletedFirst Submitted
Initial submission to the registry
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
July 28, 2026
July 1, 2026
6 months
July 23, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MASI Score
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of treatment period.
6 months
Study Arms (2)
Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)
EXPERIMENTALTriple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ali Amar, MBBS, FCPS, CHPE
Combined Military Hospital Abbottabad
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Kiran Nawaz Jadoon
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 28, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
January 14, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made publicly available due to privacy and confidentiality considerations. Only aggregated study results may be reported or published.