Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne
研究概览
简要总结
Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification.
Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects.
详细描述
This is an open controlled clinical trial. The product will be applied for a period of 4 weeks and 3 visits will be performed: a baseline visit (T0), an intermediate visit after 2 weeks (T2) and a final visit after 4 week-treatment (T4).
The subjects will be enrolled and divided in 2 groups according to their acne grade (20 subjects with mild/moderate grade and 20 subjects with moderately severe/severe), a concomitant therapy is allowed only for volunteers with acne moderately severe/severe.
Each volunteer, fulfilling the inclusion criteria, will perform a cosmetic treatment with the study product on all the face, for 4 weeks.
A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both genders;
- •age > 16 years old;
- •acne of mild/moderate grade, not in therapy (GROUP 1);
- •acne of moderately severe/severe grade, in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2);
- •accepting to follow the instructions received by the investigator;
- •available to return to the study centre at the protocol visits;
- •accepting to not change the normal life habits regarding: food, physical activity, face cleansing;
- •accepting not to receive any other drug/cosmetic treatment able to interfere with the study results;
- •accepting to sign the informed consent form (under 18 years the signature of both parents is required).
排除标准
- •Pregnancy (only for female subjects) - for subjects belonging to Group 2, a control pregnancy test could be required at T2 and T4 in case of assumption of an anti-acne drug with potential teratogenic effects; these subjects must confirm to use adequate contraceptive precautions in order to avoid pregnancies;
- •lactation (only for female subjects);
- •subjects whose insufficient adhesion to the study protocol is expected;
- •subjects who changed the anti-acne therapy during the 2 months prior to the study inclusion;
- •concomitant participation in other studies or in the last 3 months.
结局指标
主要结局
clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne
时间窗: 1 month
Visual evaluations (comedones, dryness, desquamation, papules, pustoles, microcystis) Tissue dielectric constant (superficial and deep hydration), sebumetry and optical colorimetry (skin colour), follicular biopsy, sebutape image analysis
次要结局
- subjects' self assessment(1 month)