Efficacy of La Roche Posay Routine in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP)

The sample size of this study is 80 participants; 40 subjects testing Niacinamide A serum and UV Mune and 40 subjects testing Eucerin Thiamidol anti-pigment serum and Eucerin SPF 50+. The secondary objectives are:

• the effect on the cutaneous acceptability by clinical examination under dermatological control
• the effect of the product on acne lesions is assessed by comparing the number of elements on the face before application and after product use
• the effect on acne severity according to the Global Acne Evaluation
• the mean darkness of the post-inflammatory hyper-pigmentation (PIHP) lesions. A statistical analysis of the following will be done: a comparison of the before/after application, a comparison of the values obtained from the comparison product/comparator product, and a comparison PIHP lesion/normal zone.

The study endpoints are:

• global acne evaluation scale
• mean size, intensity, number of PIHP lesion
• mean darkness of lesions
• subject global assessment score
• improvement in scores in a stigmatization questionnaire
• satisfaction questionnaire

Inclusion criteria

• Fitzpatrick skin phototype: III to VI;
• Moderate to severe PIHP due to acne (score PAHPI > 10);
• Subjects with mild acne on the face (GEA = 2);
• ≤ 4 inflammatory lesions total (non-inflammatory lesions could be 0)

Exclusion criteria

• Subjects with symptoms of COVID-19 (moderate fever, dry cough and other symptoms described by the World Health Organization);
• Subjects with a temperature above 37.5 °C;
• COVID-19 positive patients;
• For women: pregnant or nursing woman or woman planning to get pregnant during the study;
• Cutaneous pathology on the study zone (eczema, etc);
• Use of topical or systemic treatment (for ex: treatment of acne) during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product;
• Subject with make-up products on the day of the visit at the laboratory;
• Acne and depigmenting treatment (topical or systemic):
• Topical treatment claiming depigmenting effect of the face: within the last month,
• Facial procedures: within the last 3 months,
• Systemic retinoid: within the last 6 months.
• Cosmetic product for non-comedogenicity within the last 2 weeks;
• Subjects treated for PIHP within the past 3 months with either a cosmetic product or a drug;
• Any change in hormonal treatment (including contraceptive) during the three previous months of the study;
• Subject having undergone a surgery under general anesthesia within the previous month;
• Excessive exposure to sunlight or UV-rays within the previous month;
• Subject enrolled in another clinical trial during the study period.