Clinical Efficacy of the Product in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Subjects

Evaluation of the Efficacy of Niacinamide a in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Test Under Dermatological Control

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.

Study Overview

• Status: Completed
• Conditions: Acne; Post-inflammatory Hyperpigmentation

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.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Mauritius
  • Port Louis, Mauritius
    • CIDP Ltée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From baseline to Days 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From baseline to Days 84
Subject Global Assessment	Global Evaluation with 6 grades ( -1, Worsered; 4 : Totally Cleared)	From baseline to Days 84

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Principal Investigator: Gitanjali Gitanjali, MBBS, DDV, CIDP Ltée

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: 2223CMCL076 _ LRP 22061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No