Melasma.
Conditions
Interventions
Intervention 1: Intervention group: Patients will use on one side of their face a cream containing Raphanus sativus seed extract based on propylene glycol and with a concentration of 25%, twice a day
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinical diagnosis of melasma by a dermatologist (at the Center for Dermatology and Leprosy Research) Female gender Age of over 18 years Bilateral facial melasma
Exclusion criteria
Exclusion criteria: Pregnancy and breastfeeding Use of any topical treatment for melasma during 2 months before the start of the study Taking oral contraceptives and hormonal drugs for 4 weeks before the study Use of drugs that increase sensitivity to sunlight; Such as doxycycline, minocycline, tetracycline, ciprofloxacin, hydrochlorothiazide and sulfonamides The presence of scars, tattoos, excessive hair, or any other condition that makes the test site less likely to be evaluated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MMASI = Modified Melasma Area and Severity Index. This index is generally calculated based on the following formula: MMASI = 0.3 A (f) D (f) + 0.3 A (Lm) D (Lm) + 0.3 A (Rm) D (Rm + 0.1 A (C) D (C) . Area = A, Darkness= D, lesions in the Forehead = F, Right malar = Rm, Left malar = Lm and Chin = C. Our MMASI is evaluated separately in each half of the face, calculated with the following formula: Modified MASI score = (f) 0.15A (D + H) + (m) 0.3A (D + H) + ( c) 0.05A (D + H) The calculated number varies between zero and 24 depending on the severity of the lesion, the higher the score indicates the severity of the lesion. The Area (A) is determined between zero and 6; So that: 0 = 0% - 1 = 1 to 9% - 2 = 10 to 29% - 3 = 30 to 49% - 4 = 50 to 69% - 5 = 70 to 89% - 6 = 90 to 100% Darkness (D), used to determine the maxameter at the Center for Dermatology and Leprosy Research, is rated between zero and 4; In this way: 0 = normal; 1 = very low opacity; 2 = low opacity; 3 = significant opacity; 4 = severe opacity. Homogeneity (H) is also graded between zero and 4: 0 = non-homogeneity; 1 = low homogeneity; 2 = moderate homogeneity; 3 = high homogeneity. Timepoint: At the beginning of the study (before the intervention) and 6 weeks, 12 weeks and 16 weeks after the intervention. Method of measurement: Photograph with visio face camera to evaluate the darkness of facial skin and mexameter to examine Modified Melasma Area and Severity Index. | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale. Timepoint: Before the intervention, the 6th and 12th week after the intervention. Method of measurement: Scaled questionnaire from zero to 10.;Self-assessment. Timepoint: 6th and 12th week after the intervention. Method of measurement: Five-point Likert Scale.;Possible skin complications. Timepoint: 6th and 12th week after intervention. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Sharifi
Tehran University of Medical Sciences
Outcome results
None listed