Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)
研究概览
简要总结
Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 12 years of age
- •Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
- •Fitzpatrick skin type IV to VI
- •Acne IGA (Investigator Global Assessment) score of 2 or 3
- •Inflammatory lesions of 15-60 (with no more than 2 nodules)
- •Non-inflammatory lesions of 20-100
- •Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of 3,4 or 5
- •Able to understand the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must have the written informed consent of a parent or legal guardian
排除标准
- •Female subjects who are pregnant, breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control
- •Allergy or sensitivity to any component of the test medication
- •Subjects who have not complied with the wash out periods for prohibited medications
- •Medical condition that contraindicates participation
- •Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH
- •Evidence of recent alcohol or drug abuse
- •History of poor cooperation, non-compliance or unreliability
- •Exposure to an investigational drug study within 30 day of Baseline visit
研究组 & 干预措施
Azelaic acid 15% (Finacea)
Open label pilot study, Topical gel to be appiled twice daily for 16 weeks
干预措施: Azelaic acid (Drug)
结局指标
主要结局
Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)
时间窗: Baseline to 16 weeks
IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.
次要结局
- Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution(Baseline to 16 weeks)
- Percentage Change in Total Lesion Counts(Baseline to 16 weeks)
- Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)(Baseline to16 weeks)
- Tolerability Assessments as Measured by the Number of Participants With Side Effects(16 weeks)
研究者
Leon Kircik, M.D.
Principal Investigator
Derm Research, PLLC