RecruitingPhase 3Phase 4ACTRN12626000420347

comparison of the therapeutic efficacy and safety of combined oral tranexamic acid and topical hydroquinone 4% vs. topical hydroquinone 4% alone in melasma

Sponsor

pakistan naval ship shifa hospital, karachi

Enrollment

60 participants

Start Date

Jan 15, 2026

Study Type

Interventional

Conditions

Melasma

Summary

A comparative study will be conducted at dermatology out-patient department, PNS Shifa Hospital Karachi after fulfilling the inclusion and exclusion criteria. 60 patients with melasma will be divided 2 groups. Group A with Oral Transamine 250 mg twice daily and topical 4% hydroquinone) is having better or equal efficacy to Group B (topical 4% hydroquinone only).They will receive treatment for 12 weeks and data from patient will be conducted through a proforma on first visit and followups.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria4

Both genders
years and older with clinically diagnosed melasma (epidermal or mixed) lasting >3 months.
Fitzpatrick skin types II-IV
written informed consent

Exclusion Criteria6

pregnancy or lactation
known hypersensitivity to study medications
use of systemic or topical anti melasma treatments with prior 2-3 months
presence of active dermatological conditions on treatment sites
contraindications to tranexamic acid
concurrent clinical trial participation or poor compliance potential

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Interventions

Patients will be divided in two groups. Group A will receive a combination therapy of oral tranexamic acid 250 mg twice daily plus 0.25 mg topical hydroquinone 4% for 12 weeks . Data collection will

Patients will be divided in two groups. Group A will receive a combination therapy of oral tranexamic acid 250 mg twice daily plus 0.25 mg topical hydroquinone 4% for 12 weeks . Data collection will involve baseline assessment and follow-up visits at weeks 4 , 8, and 12. Data recorded will include participant. demographics, Melasma Area Severity index (MASI) scores, photographs and adverse events. Patients adherence to intervention will be monitored with patient diary of the oral medicine taken twice daily and cream applied at night daily . Treatment response will be assessed by change in MASI score and therapeutic response. Side effects of the treatment will be assessed at followup including local and systemic.