A Pilot Study on the Comparative Efficacy and Tolerability of a Novel Dermo-cosmetic Cream With 15% Azelaic Acid for Mild to Moderate Acne: A New Approach to Acne Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in acne severity total lesion score
研究概览
简要总结
The goal of this non-interventional, observational study is to evaluate the real-world efficacy and tolerance of a novel dermocosmetic cream containing 15% Azelaic acid and a complex of active ingredients (α-AZ cream) in patients with mild-to-moderate acne treated in routine clinical practice.
The main questions addressed are:
- Does the product show good clinical efficacy on acne and inflammatory lesions in standard practice?
- Does the product offer good cutaneous tolerance during routine use?
Patients are observed across three routine care cohorts according to their prescribed/recommended regimen: α-AZ cream alone (Group 1), α-AZ cream combined with an oral acne treatment (Group 2), or a topical acne treatment (Group 3), over a period of 84 days. The study observes and compares real-world outcomes and tolerance across these standard care management approaches without imposing any protocol-driven treatment allocation.
Researchers will compare the new dermocosmetic cream with group 2 and group 3 to see if the study product shows an equivalent or a better tolerance/efficiency than the drug treatment.
详细描述
Background and study aims:
Acne vulgaris is a prevalent skin condition, especially among teenagers and young adults. Traditional treatments, including topical retinoids and antibiotics, often lead to side effects that reduce adherence and effectiveness.The study aimed to evaluate the efficacy and tolerability of a novel dermo-cosmetic cream containing 15% azelaic acid in alleviating acne burden in patients with mild-to-moderate acne.
Study Nature and Non-Intervention:
This is a purely observational study. Treatment choices (including α-AZ cream and/or standard anti-acne medications) are made solely at the discretion of the treating physician in accordance with routine medical practice, independently of and prior to patient inclusion in the study. Participation in the study does not alter the patient's therapeutic care, and no protocol-mandated interventions or additional invasive procedures are imposed.
Who can participate? Patients aged 12 years and older presenting with mild-to-moderate acne managed in routine clinical practice.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex: female and/or male
- •Subject having given his/her informed written consent or parental authorization
- •Subject willing to adhere to the protocol and study procedures
- •Healthy subject with acne-prone skin: grade 2 or 3 (Global Acne Evaluation [GEA] scale).
排除标准
- •Excluding treatment:
- •Epiduo® or combination of benzoyl peroxide (BPO) + Adapalene
- •Oral isotretinoin
- •Chronically used anti-inflammatory drugs
- •Subject manipulating his/her acneic lesions
- •Any change in hormonal treatment (including contraceptives) during the three previous months of the study
- •Cutaneous pathology on the study zone (eczema, etc)
- •Excessive exposure to sunlight or UV rays within the previous month
- •Subject enrolled in another clinical trial during the study period
研究组 & 干预措施
Teen Derm AZ: Azelaic acid cream with active ingredients (named α-AZ cream, Group 1)
α-AZ cream combined with oral antibiotic: Doxycycline (Group 2)
Cosmetic product applied once per day + Oral doxycycline 100 mg administered once daily as prescribed in routine clinical practice.
Topical antibiotic cream, Erythromycin / Zinc Acetate (Group 3)
Topical solution/cream combining erythromycin 40 mg/mL and zinc 12 mg/mL applied according to standard care.
结局指标
主要结局
Percentage change from baseline in acne severity total lesion score
时间窗: Baseline, Day 42, Day 84, and Day 112
Acne severity evaluated by counting open/closed comedones (R), papules/pustules (Is), and nodules (Ip) on a scale from 0 (clear) to 5 (severe). Total score is calculated as R + Ip + Is, and relative change (%) from baseline is reported.
Percentage change from baseline in Post-Inflammatory Hyperpigmentation (PIH) score
时间窗: Baseline, Day 42, Day 84, and Day 112
Evaluation of post-hyper-pigmentation inflammatory marks categorized as none (≤2), mild (3-4), moderate (5-6), or severe (7-8). Relative change (%) from baseline is reported.
次要结局
- Change from baseline in Quality of Life assessed by the Cardiff Acne Disability Index (CADI)(Baseline, Day 84, Day 112)
- Tolerability of the product and patient satisfaction(Baseline, Day 42,Day 84, and Day 112)