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

NCT06822335 | Completed

• 1 other identifier: 2223CMCL076 _ LRP 22061
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne; Post-inflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• CLINICAL ASSESSMENT OF ACNE SEVERITY

  From baseline to Days 84

• Subject Global Assessment

  From baseline to Days 84

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP Ltee

Port Louis, Mauritius

Location

MeSH Terms

Conditions

Acne Vulgaris; Hyperpigmentation

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pigmentation Disorders

Study Officials

• Gitanjali Gitanjali, MBBS, DDV

  CIDP Ltée

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: February 12, 2025
• Study Start: April 3, 2023
• Primary Completion: August 7, 2023
• Study Completion: August 8, 2023
• Last Updated: February 12, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)