An Open-label Study Evaluating the Clinical Benefits and Safety of Combined Polynucleotides and Hyaluronic Acid - Newest - for Acne Scars Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Goodman Baron score
研究概览
简要总结
This clinical study wants to evaluate the efficacy and safety of a medical device combining "Polynucleotide Highly Purified Technology" (PN-HPT™) and hyaluronic acid (Newest-Mastelli S.r.l) for treating moderate-to-severe atrophic post-acne scars.
详细描述
This is a prospective, open label study aimed to evaluate efficacy and safety of Newest in facial acne scars treatment. The study will be conducted at Fatebenefratelli Hospital in Rome (Italy). All procedures have to be conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 and 2008.
A subject will be involved in the study for 6 months and photographs and instrumental assessment (Antera 3 D) will be performed at 1 months, 2 months, 3 months and 6 months after first treatment administration; results will be compared with basal line evaluation (T0).
The sample size of 30 patients has been selected, based on the previous clinical results obtained from a "Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars". This sample size combined with this study model is statistically sufficient to provide robust estimation of the primary endpoint.
The study primary objective is to show the clinical improvement in acne facial scars treated with Newest.
The primary end-point of the study is the variation of post-acne scars characteristics evaluated through the Goodman Baron scale at follow up visits F.U. 3 and F.U. 6 versus baseline visit (T1). At the end of follow-up, an average reduction of at least two points of the Goodman score versus baseline will be considered as a positive outcome.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, with age ≥ 20 and ≤ 60 years with an approximately symmetric number of atrophic acne scars on the whole face;
- •Subject presenting a grade 3 to 4 according to Goodman classification corresponding to moderate-to-severe atrophic post-acne facial scars;
- •Scar lesions have not be active
- •Subject who never underwent surgical or laser face treatment for acne scars;
- •Subjects with prior administration of oral steroids and/or isotretinoin should have interrupted this therapy at least 6 months before study kick off.
- •Subject who agree to discontinue all dermatological treatment and procedures during the study;
- •Subject willing to provide signed informed consent to clinical investigation participation;
- •Subject able to communicate adequately with the Investigator and to comply with the requirements for the entire study
排除标准
- •Patients younger than 20 or older than 60 years;
- •Subjects with mild atrophic acne scars according to the Goodman classification (grade 1-2);
- •Pregnancy or breastfeeding women;
- •Systemic or local illnesses that might affect wound healing
- •Severe solar elastosis or scarring;
- •Concomitant intake of anticoagulant or antiplatelet medications;
- •Subjects who have followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;
- •History of autoimmune disease or chronic drug or alcohol abuse
结局指标
主要结局
Goodman Baron score
时间窗: 6 months
The primary end-point of the study is the blinded assessment of variations of scar characteristics evaluated through the Goodman Baron score at scheduled visits versus baseline visit (T1)
次要结局
- Global Aesthetic Improvement Scale(6 months)
- Skin quality difference(6 months)
- Adverse events (AE)(6 months)