The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.
all phototypes
only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study
patient agreeing not to be exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), during the study
female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
severe melasma, dermal melasma
Parallel
tested product
Other interventionapplication twice a day of the tested product (in the morning and evening) and a sunscreen (in the morning and at midday) to the face for 3 months
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding skin)
modified Melasma Area and Severity Index (mMASI) for patients with melasma
The mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar, chin); area of involvement for each region (using a scale from 0 to 6); darkness compared to the surrounding normal skin for each area (using a scale from 0 to 6.
Post-Acne Hyperpigmentation Index (PAHPI)
The PAHPI total score is the sum of all 3 weighted scores: median lesion size (from 2 \[\< 3mm\] to 8 \[\> 10 mm\], median lesion intensity (from 3 \[slightly darker than surrounding skin,\] to 9 \[significantly darker than surrounding skin\] and number of lesions (from 1 \[1-15\] to 5 \[\> 60\]. Total score ranges from 6 to 22.
solar lentigo pigmentation scale
the solar lentigo pigmentation scale evaluates the pigmentation using the following scale: from 0 (no pigmentation) to 10 (brown+).
colorimetry measures
Skin color is measured using the L\*a\*b\* color space (L\* represents lightness, a\* its position between green and red, b\* its position between blue and yellow).
Click on the lead sponsor to view all of their trials.
