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 range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

POST ACNE HYPERPIGMENTATION INDEX (PAHPI)

Timeframe: From baseline to Days 84

Trial details

NCT IDNCT06822335

SponsorCosmetique Active International

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08-07

View on ClinicalTrials.gov More Acne trials