Melasema. Chloasma
Conditions
Interventions
Intervention 1: Control group: :Participants in the control group receive fractional Q-switched 1064-nm ND:YAG laser therapy with melasma-specific settings (average energy 600 nm, 5 Hz, spot size = 5
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The study includes individuals with melasma presenting unilaterally, bilaterally, or on the forehead.
Exclusion criteria
Exclusion criteria: 1. Presence of other inflammatory dermatoses in the affected areas (e.g., rosacea, lupus, atopic dermatitis)2. History of photosensitive disorders or use of photosensitizing medications3. Pregnancy or lactation at the time of study entry4. History of hypersensitivity or allergy to Kligman's formula or any of its components5. Undergoing effective treatments for melasma (e.g., laser therapy, chemical peeling, microneedling) within the past 3 months6. Uncontrolled systemic diseases (e.g., uncontrolled diabetes, active hepatic or renal disease)7. Use of hormonal medications (e.g., oral contraceptives or hormone therapy) within the past 3 months8. Lack of willingness to adhere to treatment protocols or attend follow-up visits9. Presence of prominent scars or tattoos in the melasma-affected areas that may interfere with evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melasma severity is evaluated based on the Melasma Area and Severity Index (MASI) score in the forehead, right malar, and left malar regions. The MASI score incorporates assessment of involved area, pigmentation intensity, and homogeneity of the lesion. Timepoint: MASI is measured at baseline (before the start of treatment), one month after the start of treatment, and two months after the start of treatment. Method of measurement: Clinical examination and recording of MASI score by a dermatologist using the standard calculation formula.;Overall patient satisfaction with the treatment outcome is assessed two months after the start of treatment using a 5-point ordinal scale (excellent, good, moderate, poor, no satisfaction). Timepoint: At the end of the second month of treatment. Method of measurement: Patient interview and recording of response using an ordinal scale form. | — |
Secondary
| Measure | Time frame |
|---|---|
| The intensity of itching in the treated area. Timepoint: Immediately after treatment, one week after treatment, and one month after treatment. Method of measurement: Patient-reported numerical rating scale from zero (no itching) to ten (worst imaginable itching).;The intensity of burning sensation in the treated area. Timepoint: Immediately after treatment, one week after treatment, and one month after treatment. Method of measurement: Patient-reported numerical rating scale from zero (no burning) to ten (worst imaginable burning).;Patient satisfaction level regarding treatment outcome. Timepoint: One month and two months after the beginning of treatment. Method of measurement: Patient-reported five-point Likert scale satisfaction questionnaire (from completely dissatisfied to completely satisfied). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Rahimi
Iran University of Medical Sciences
Outcome results
None listed