Clinical Efficacy of the Product in the Management of Facial Post Inflammatory Hyperpigmentation … (NCT06822335) | Clinical Trial Compass
CompletedNot Applicable
Clinical Efficacy of the Product in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Subjects
Mauritius65 participantsStarted 2023-04-03
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Female and male subjects aged between 18 - 50 years old.
* Subject of Fitzpatrick phototype III-VI.
* Subject must be willing and be able to comply with the study schedule, procedures, and restrictions.
* Subjects with moderate to severe scores (4-8) on mean darkness intensity.
* Subjects with moderate to severe PIHP due to acne (score PAPHI\>10).
* Subjects with mild acne (GEA 2),
* Subjects having ≤ 4 inflammatory lesions total,
* Subjects showing understanding of the study procedures, restrictions, willingness to participate as evidenced by voluntary written informed consent.
Exclusion criteria
* Pregnant or intending to become pregnant during the study or breastfeeding or in menopause.
* Subjects under any hormonal therapy, such as contraceptive pills or androgen agonist/antagonist medications, within the last 3 months before Visit 1 or planning to start any therapy during the study.
* Subject with cutaneous pathology on the studied zone other than acne (eczema etc.).
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products (according to the investigator's appreciation).
* Moderate to severe acne (GEA \>2).
* Systemic treatment of retinoids during the six previous months of the study.
* Under retinoid treatment within the last 6 months, including Over. The Counter (OTC) and all derivates of retinoids (e.g., retinol, retinal, retinaldehyde, ret…