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

The goal of this clinical trial is to test and compare La Roche Posay routine --the studied product-- with a comparator product in participants with acne. The main question it aims to answer is how well can the product de-pigment the skin.

The participants will be asked to use the products given twice daily. Researchers will compare the routine La Roche Posay group(experimental) with the routine Eucine group(control) to see if the La Roche product shows superiority in case of better efficacy.

Study Overview

• Status: Completed
• Conditions: Acne; Postinflammatory Hyperpigmentation

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Mauritius
  • Quatre Bornes, Mauritius
    • Insight Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals with Fitzpatrick skin phototype III to VI who have moderate to severe PIHP due to acne (score PAHPI >10). Subjects with mild face acne (GEA = 2) and ≤4 total inflammatory lesions (including 0).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Routine La Roche Posay; Niacinamide A serum and UV Mune
Routine Thiamidol; Eucerin Thiamidol antipigment serum and Eucerin SPF50+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical scoring of the post-acne hyperpigmentation index	The scoring performed by the investigator on day 0, day 28, day 56 and day 84 from the day of product use. Descriptive statistics where the frequency and percentage frequency of mean size, intensity, number of PIHP lesions and the global score will be calculated to infer the effect of the product on the skin.	84 days

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Kate Randamy, Insight Research

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: LRP 22048-Serum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No