An observational study in Acne and Post-inflammatory Hyperpigmentation, sponsored by Cosmetique Active International. Completed at 1 site in Mauritius. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Cosmetique Active International (part of L'Oréal) · Observational
Double-blind, randomized, clinical study is designed to evaluate the efficacy of Niacinamide A in the management of facial Post Inflammatory Hyper Pigmentation (PIHP) in healthy female and male subjects with moderate to severe PIHP due to acne, mild acne and (≤4) inflammatory lesions, its impact on skin lightening effect and lastly any associated benefits on skin quality.
Primary objective To investigate the depigmenting effect of Niacinamide A in moderate to severe facial post inflammatory hyperpigmentation due to acne after a 12-week application period.
Secondary objectives
To evaluate any associated benefit of the product on skin condition and skin imperfection at different timepoints:
Product lightening efficacy using the Spectrocolorimeter. Evaluation of the global assessment evaluation for acne severity by the investigator using a 6 -point scale.
Counting of non-inflammatory and inflammatory lesions to access the change on the face.
Investigator scoring to assess the local intolerance (erythema, edema, dryness).
Subject scoring to assess the local intolerance(burning, stinging, itching and tingling sensations).
Subjective assessment of global tolerance of the product using a 4-point scale. Skin imaging analysis to assess the evaluation of the PIHP(darkness, size, number brown spots).
Evaluation of the mean darkness. Subjective evaluation of Global Assessment(SGA). Subject questionnaires to assess consumer perceived skin endpoints by filling in a cosmetic evaluation questionnaire and a stigmatization questionnaire.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 65 is below the median of 88 across 95 observational studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Cosmetique Active International is the lead sponsor of 55 studies on the registry; 13 are open to participants now.
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female and male subjects with (Fitzpatrick phototype III-VI), aged between 18 and 50 years old, with moderate to severe PIHP due to acne (score PIHP > 10), with mild acne (GEA 2) and having inflammatory lesions (≤ 4 \<10).
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.
Exclusion criteria
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POST ACNE HYPERPIGMENTATION INDEX (PAHPI)
The scoring will be performed by the Investigator with the PAHPI at etch visites. The score is composed by 3 parameters: Median Lesion size with 4 grades ( \<3mm, 3-6mm, 7-10mm, \>10 mm) , intensity with 3 grades ( slightly darker, Moderate darker, significant darker) and number of PIHP lesions with5 grades ( 01-15 lesions, 16-30 lesions, 31-45 lesions, 46-60 lésions, \>60 lesions . The global score will be calculated (6 to 22).
Time frame: From baseline to Days 84
CLINICAL ASSESSMENT OF ACNE SEVERITY
The dermatologist evaluates the acne severity according to the Global Acne Evaluation with the scale of 5 grades (0 Clear) to 5 ( Very severe)
Time frame: From baseline to Days 84
Subject Global Assessment
Global Evaluation with 6 grades ( -1, Worsered; 4 : Totally Cleared)
Time frame: From baseline to Days 84
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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