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

NCT06770127 | Completed

• 1 other identifier: LRP 22048-Serum
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne; Postinflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Routine La Roche Posay

Niacinamide A serum and UV Mune

Routine Thiamidol

Eucerin Thiamidol antipigment serum and Eucerin SPF50+

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

Insight Research

Quatre Bornes, Mauritius

Location

MeSH Terms

Conditions

Acne Vulgaris; Hyperpigmentation

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pigmentation Disorders

Study Officials

• Kate Randamy

  Insight Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: February 27, 2023
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: January 13, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)