Evaluation of the effect of microneedling with tranexamic acid in combination with hydroquinone formula in comparison with either alone in the treatment of melasma
Phase 2
- Conditions
- Melasma.ChloasmaL81.1
- Registration Number
- IRCT20220122053789N1
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Age 18 to 60 years old
Clinical diagnosis of bilateral melasma of the cheek
Exclusion Criteria
Patients who have received any treatment for melasma in the past 1 month.
Patients who have contraindications to tranexamic acid. (Includes known drug allergy, intracranial hemorrhage, known color vision disorder, history of arterial or venous thromboembolism or active thromboembolic disease, ischemic heart disease, and stroke)
Patients with mental instability (which is expected to affect the study process).
Patients who do not have informed consent to participate in the study.
Patients who do not have the opportunity to visit regularly and cooperate for scoring and follow-up sessions.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: By modified Melasma Area & Severity Index and Visual Analogue Scale.
- Secondary Outcome Measures
Name Time Method Safety. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: Ask from the patient for possible adverse effects.;Satisfaction. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: Based on patient scoring.