Clinical assessment of the efficacy of topical nano-formulation of tranexamic acid/niacinamide in melasma
- Conditions
- Melasma.Other disorders of pigmentation
- Registration Number
- IRCT20220609055116N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 102
Patients (Male/female) with melasma between 18 and 50 years old
Patients who have had melasma for at least 6 months ago
Patients who are capable to understand, read, and write the informed consent form
Patients who are able to participate in periodic follow-up visits by physician
Patients who have received oral contraceptive (OCP) therapy within 3 months prior to the study initiation or during the study
Patients who are receiving oral corticosteroids or applying topical corticosteroids on melasma lesions during the study
Patients with a history of thyroid disease
Patients with a history of intolerance, hypersensitivity reactions, or severe irritation to hydroquinone, tranexamic acid, or niacinamide,
Patients with other hyperpigmentary disorders
Pregnancy or lactation
Patients who have received any pharmacologic or procedural treatment within 2 months prior to the study initiation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In each follow-up, standard skin photography will be performed from the left, right, and front sides of the faces of the patients using Visioface 1000D instrument (CK Electronic, Germany) and modified melasma area and severity (mMASI) score, as a major assessment tool in melasma, will be calculated accordingly. Timepoint: Clinical responses to the topical treatment will be assessed every 4 weeks up to 3 months in patients with melasma. Method of measurement: Modified MASI score = 0.3 × Area (forehead) × Darkness (forehead) + 0.3 × Area (left malar) × Darkness (left malar) + 0.3 × Area (right malar) × Darkness (right malar) + 0.1 × Area (chin) × Darkness (chin).
- Secondary Outcome Measures
Name Time Method Patients' quality of life will be assessed through the Melasma Quality of Life Scale (MELASQOL) questionnaire. Timepoint: Patients' quality of life will be assessed before treatment initiation and also at the end of the study (after 3 months of treatment). Method of measurement: Patients' quality of life will be assessed through the Melasma Quality of Life Scale (MELASQOL) questionnaire in which validity and reliability are confirmed.