Mild to moderate facial dyspigmentation due to melasma, but otherwise healthy skin Skin and Connective Tissue Diseases
Conditions
Interventions
Subjects are randomly assigned to one of the two treatment groups.
In the intervention group (CCP group), subjects receive the combination of cosmetic products (CCP): Neotone® serum o
Sponsors
ISISPHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women or men 2. Aged between 18 and 60 years 3. Skin phototype IV-V 4. Presenting facial dyspigmentation due to melasma as determined by Wood’s light examination
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women or women planning to get pregnant during the study 2. Subjects with a cutaneous pathology on the study zone (eczema) 3. Subjects having undergone surgery under general anaesthesia within the previous month 4. Individuals who have been excessively exposed to sunlight or UV-rays within the previous month 5. Subjects having used topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical scoring of the dyspigmentation with the Modified-MASI score (M-MASI; Dr Amit PANDYA) is performed at baseline, week 6 and week 12 2. Cutaneous color assessed using the Spectrocolorimeter® at baseline, week 6 and week 12 3. Expected visual effect is assessed with photographs taken at baseline, week 6 and week 12 4. Cutaneous acceptability assessed by clinical examination under dermatological control at baseline, week 6 and week 12 5. Cosmetic acceptability and future use is assessed by analysis of the subjects’ answers to a subjective evaluation questionnaire at week 6 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Mauritius
Outcome results
None listed