Melasma. Other disorders of pigmentation
Conditions
Interventions
Intervention 1: First group: Patients receiving topical niosomal tranexamic acid %2-niacinamide %2 formulation twice daily for 3 months. Intervention 2: Second group: Patients receiving topical tranex
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactProf. Soliman Mohammadi-Samani
Shiraz University of Medical Sciences
Outcome results
None listed