NCT05821296已完成不适用
Evaluation of the Efficacy and Tolerance of Crystal Peel (a Salicylic Acid Based Peel) in the Treatment of Acne
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Comparison of the Change From Baseline of Count Lesions on Each Visit to Evaluate the Efficacy and Clinical Performance of Crystal Peel for the Treatment of Acne.
研究概览
简要总结
The goal of this interventional, confirmatory and post market study is to evaluate the efficacy and clinical performance of Crystal Peel in adults suffering mild facial acne vulgaris. The principal and secondary aims are:
- Principal aim: to evaluate the efficacy and clinical performance of Crystal Peel, a salicylic-based peel, for the treatment of acne by lesions counting (front, 2 cheeks, the chin above the jaw line (excluding the nose)) using both visual observation and palpation.
- Secondary aims: pores and texture analysis, visual effect (Standardized anonymized photographs, investigator global assessment, patient global assessment, local and overall tolerance of the Crystal Peel, subject's self-evaluation and potential adverse events collection.
The primary endpoint of the study will be an objective counting of the acne lesions performed on every visit.
详细描述
Total lesions will be defined as the sum of inflammatory lesions (papules and pustules), non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects
- •Gender: female and/or male.
- •Age: 18 - 45
- •Phototype I to IV according Fitzpatrick scale.
- •Healthy subject with normal physical examination results and a medical history compatible with the requirements of the study.
- •A healthy male or female subject with a medical diagnosis of mild to moderate facial acne vulgaris defined by at least 6 (six) inflammatory lesions, 12 (twelve) non-inflammatory lesions and no more than 2 (two) nodules (the nose is excluded for lesion count purposes).
- •Subject declares to avoid exposure to UV radiation (tanning booths, phototherapy and sun) on the face for at least three months prior to the selection visit and agrees to avoid it throughout the study.
- •Subject agrees not to apply any cosmetic, medical or aesthetic treatments outside the study protocol on the face for the duration of the study.
- •For female subjects:
- •Female subject not in childbearing status (tubal ligation, hysterectomy, bilateral oophorectomy), or Female subjects of childbearing potential who, in the opinion of the investigator, are using a reliable method of contraception (pill or contraceptive patch, IUD, implant or vaginal ring,condoms) for at least one month prior to the screening visit. Subject willing to continue using contraception during the study and one month after the end of the study.
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- •Subject in a social or sanitary establishment.
- •Subject participating to another clinical research or being in an exclusion period for a previous study.
- •Intensive exposure to sunlight or UV-rays within the previous 3 months and foreseen during the study.
- •Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk.
- •Subject having history of allergy or hypersensitivity to one of the components of the tested device.
- •Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.
- •Subjects on topical or oral treatments (such as Benzoyl Peroxide, Retinoic Acid, isotretinoin) that did not stop the treatment 30 days before their first peel (risk of over-peeling).
- •Subjects with known salicylism or related medical indications.
结局指标
主要结局
Comparison of the Change From Baseline of Count Lesions on Each Visit to Evaluate the Efficacy and Clinical Performance of Crystal Peel for the Treatment of Acne.
时间窗: At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).
Lesion counting using both visual observation and palpation. Total lesions (front, 2 cheeks, the chin above the jaw line (excluding the nose)) will be defined as the sum of inflammatory lesions (papules, pustules), non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules).
次要结局
- Acne Investigator Global Assessment (IGA) Score(At Visit 5/Day 78.)
- Acne Patient Global Assessment (PGA) Scale(At Visit 5/Day 78.)
- Local and Overall Tolerance of the Crystal Peel.(At Visit 5/Day 78).)
- Subject's Satisfaction Questionnaire(At Visit 5/Day 78.)
- Number of Adverse Events(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Relative Area (Density) of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Area of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Depth of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Length of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
- Comparison of Change From Baseline of Conspicuous Volume of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.(At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).)
研究者
研究点 (1)
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