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CompletedNCT06770127PIHPUpdated Jan 13, 2025

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

An observational study in Acne and Postinflammatory Hyperpigmentation, sponsored by Cosmetique Active International. Completed at 1 site in Mauritius. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Cosmetique Active International (part of L'Oréal) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Acne
  • Postinflammatory Hyperpigmentation
03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's enrollment of 80 is close to the median of 88 across 95 observational studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Cosmetique Active International is the lead sponsor of 55 studies on the registry; 13 are open to participants now.

Browse Cosmetique Active International studies →All L'Oréal studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ) 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Target follow-up
4 Weeks
Patient registry
Yes

Groups and cohorts

  • Routine La Roche Posay

    Niacinamide A serum and UV Mune

  • Routine Thiamidol

    Eucerin Thiamidol antipigment serum and Eucerin SPF50+

06

What researchers measure

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.

    Time frame: 84 days

07

Study locations

1 site
  • Insight Research
    Quatre Bornes, Mauritius
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2023 to primary completion in Oct 2023, 7 months.

Of 22 industry-sponsored observational studies under Acne Vulgaris, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's 7 months is below that.

Counting every sponsor, half of 37 studies reached it within 10 months; a quarter within 3 and three quarters within 13.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2025
First posted
Jan 13, 2025
StartActual
Feb 27, 2023
Primary completionActual
Oct 16, 2023
CompletionActual
Oct 16, 2023
Last update
Jan 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06770127
Lead sponsor
Cosmetique Active International
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Feb 27, 2023
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023
Last update
Jan 13, 2025

Study contacts

Kate Randamy
study director · Insight Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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