Clinical trial NCT06822335: Clinical Efficacy of the Product in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Subjects
Official title: Evaluation of the Efficacy of Niacinamide a in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Test Under Dermatological Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne
Post-inflammatory Hyperpigmentation
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief 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.

Detailed description: 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.

Eligibility criteria: 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, retinol esters, etc.).
* Under any acne medication (including oral medication/laser treatment) within the last 6 months.
* Subjects treated for PIHP within the past 3 months with either a cosmetic product or a drug.
* Subject with make-up products on the day of the visit at the center.
* Cosmetic product for non-comedogenicity within the last 2 weeks.
* History of skin cancer.
* History of abnormal response to sun.
* Presence of recent suntan (according to Investigator opinion) or photo-test marks.
* History of allergy, hypersensitivity, or any serious reaction to any cosmetic product.
* Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
* Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g., steroidal, and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics -e.g., quinolone, tetracycline, thiazides, fluoroquinolones-).
* Any subject who, in the judgment of the Investigator, should not participate in the study.
* Subject who cannot be contacted by telephone in case of emergency.
* Subject having participated within the 14 days before inclusion or currently participating in another clinical study.

Primary outcomes:
measure: POST ACNE HYPERPIGMENTATION INDEX (PAHPI)
timeFrame: From baseline to Days 84
Secondary outcomes:
measure: CLINICAL ASSESSMENT OF ACNE SEVERITY
timeFrame: From baseline to Days 84
measure: Subject Global Assessment
timeFrame: From baseline to Days 84
Other outcomes:
Locations:
city: Port Louis
country: Mauritius
facility: CIDP Ltee
Study officials:
affiliation: CIDP Ltée
name: Gitanjali Gitanjali, MBBS, DDV
role: PRINCIPAL_INVESTIGATOR
References: