NCT04943159已完成2 期
A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- The Change in Number of Facial Inflammatory Acne-related Lesions.
研究概览
简要总结
This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;
- •Chronic course of acne vulgaris;
- •Acne-related lesions both on the face, chest and back;
- •Indication for treatment of acne vulgaris;
- •Aged 18-30 years (inclusive);
- •Fitzpatrick skin types I-III;
- •Providing written Informed Consent prior to the performance of any study-specific procedure.
排除标准
- •Female subjects;
- •Diagnosis of severe acne vulgaris;
- •Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant;
- •Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;
- •Use of oral antibiotics for acne within 4 weeks prior to the first dose;
- •Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose;
- •Use of systemic retinoids within 6 months prior to the first dose;
- •Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;
- •Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose;
- •Use of tanning booths or lamps within 1 week prior to the first dose;
- •Active skin disease that may interfere with evaluation;
- •Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;
- •Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
研究组 & 干预措施
Afamelanotide group A
Experimental
干预措施: Afamelanotide (Drug)
Afamelanotide group B
Experimental
干预措施: Afamelanotide (Drug)
结局指标
主要结局
The Change in Number of Facial Inflammatory Acne-related Lesions.
时间窗: From baseline to Day 56.
次要结局
未报告次要终点
研究者
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