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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Gitanjali Gitanjali, MBBS, DDV | CIDP Ltée | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDP Ltee | Port Louis | Mauritius |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Global Evaluation with 6 grades ( -1, Worsered; 4 : Totally Cleared)
| From baseline to Days 84 |
| D010859 | Pigmentation Disorders |