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Search / Trial NCT06770127

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

Launched by COSMETIQUE ACTIVE INTERNATIONAL · Jan 7, 2025

Trial Information

Current as of June 13, 2025

Completed

Keywords

ClinConnect Summary

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)...

Gender

ALL

Eligibility criteria

  • 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.

About Cosmetique Active International

Cosmetique Active International is a leading global sponsor of clinical trials focused on the development and evaluation of innovative cosmetic and dermatological products. Committed to advancing skin health and beauty, the organization leverages cutting-edge research methodologies and robust clinical protocols to ensure the safety and efficacy of its formulations. With a multidisciplinary team of experts in dermatology, pharmacology, and regulatory affairs, Cosmetique Active International collaborates with diverse stakeholders to drive scientific advancements and deliver high-quality cosmetic solutions that meet the evolving needs of consumers and healthcare professionals alike.

Locations

Quatre Bornes, , Mauritius

Patients applied

0 patients applied

Trial Officials

Kate Randamy

Study Director

Insight Research

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported