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.
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
65
CIDP Ltee
Port Louis, Mauritius
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).
Time frame: From baseline to Days 84
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)
Time frame: From baseline to Days 84
Subject Global Assessment
Global Evaluation with 6 grades ( -1, Worsered; 4 : Totally Cleared)
Time frame: From baseline to Days 84
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