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.
Hyperpigmentation is a common skin condition in which the colour of the skin becomes darker. These changes result from an excess of melanin production, distribution, or transport which can be caused by various internal and external factors such as genetic predisposition, hormonal changes, inflammation, acne, ultraviolet (UV) exposure. Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation, melasma and solar lentigines. This open, single-centre, three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation and used under normal conditions of use with before/after comparisons. This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements. Statistical Analysis: * Efficacy Analysis: in each group, the quantitative parameters are analyzed using a mixed-effect model. This model includes Time and baseline as fixed effects. Patient are added as random effect. The comparisons between post-baseline time-point and baseline are performed whatever the interaction results using a Dunnett adjustment. Degrees of freedom for the comparisons are approximated by the Kenward-Roger method. * Safety Analysis: no statistical analysis will be performed on safety. The data are presented descriptively. Categorical data are summarized using the number and percentage of patients in each category. Continuous data are summarized using the arithmetic mean, Standard Deviation (SD), Q1, Q3, minimum, median and maximum values. Regarding the sample size determination, there was no formal calculation. A number of 20 patients in each group (i.e. 60 patients in total) was considered sufficient to meet the study objective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
application 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
PhDTrials Center
Lisbon, Portugal
RECRUITINGIGA 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 (markedly darker than the surrounding normal skin)
Time frame: from baseline to Day84
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 and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 6)
Time frame: from baseline to Day 84
Post-Acne Hyperpigmentation Index (PAHPI)
The PAHPI score is the sum of all 3 weighted scores: median lesion size (from 2 \[\< 3mm\] to 8 \[\> 10mm\], 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.
Time frame: from baseline to Day 84
colorimetry measurements
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).
Time frame: from baseline to Day84
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