NCT06822335

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne
• Post-inflammatory Hyperpigmentation

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-08-07
• Completion: 2023-08-08
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: Mauritius