Evaluation of the Efficacy of Niacinamide a in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Test Under Dermatological Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- POST ACNE HYPERPIGMENTATION INDEX (PAHPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
POST ACNE HYPERPIGMENTATION INDEX (PAHPI)
时间窗: From baseline to Days 84
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).
次要结局
- CLINICAL ASSESSMENT OF ACNE SEVERITY(From baseline to Days 84)
- Subject Global Assessment(From baseline to Days 84)