AcnePIHPNCT06770127
Efficacy of La Roche Posay Routine in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP)
An observational study of Acne and Postinflammatory Hyperpigmentation, run by Cosmetique Active International at 1 site in Mauritius.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Postinflammatory Hyperpigmentation
- How many people
- 80 participants
- Where
- 1 siteMauritius
- Study dates
- 27 Feb 2023to 16 Oct 2023
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Acne, Postinflammatory Hyperpigmentation
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine La Roche Posay | Niacinamide A serum and UV Mune | |
| Routine Thiamidol | Eucerin Thiamidol antipigment serum and Eucerin SPF50+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start27 Feb 2023
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kate Randamy, Study director, Insight Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770127
- Sponsor's protocol ID
- LRP 22048-Serum
- Acronym
- PIHP
- Status last verified
- Oct 2023
- First submitted
- 7 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of La Roche Posay Routine in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP)
- ClinicalTrials.gov ID
- NCT06770127
- Acronym / sponsor ID
- PIHP / LRP 22048-Serum
- Conditions
- Acne, Postinflammatory Hyperpigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine La Roche Posay | – | –Niacinamide A serum and UV Mune |
| Routine Thiamidol | – | –Eucerin Thiamidol antipigment serum and Eucerin SPF50+ |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical scoring of the post-acne hyperpigmentation index
Time frame: 84 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Randamy study director
Insight Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne and Postinflammatory Hyperpigmentation, run by Cosmetique Active International at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical scoring of the post-acne hyperpigmentation index (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.