None listed
Conditions
Brief 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.
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 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 take
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.
Sponsors
pakistan naval ship shifa hospital, karachi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Both genders 18 years and older with clinically diagnosed melasma (epidermal or mixed) lasting >3 months. Fitzpatrick skin types II-IV written informed consent
Exclusion criteria
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
Outcome results
None listed