Use of Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Remained Responders at Week 24
研究概览
简要总结
This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel following combination treatment with with doxycycline and Aczone 5% gel can maintain therapeutic response.
详细描述
This is a two-center, open-label pilot study. The study is apprised of 7 study visits: Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and doxycycline 100mg by mouth once daily at Baseline. Those subjects achieving treatment response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID at Week 12. Subjects not achieving treatment response will discontinue study participation.
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 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient, male or female subjects of any race, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
- •Facial acne vulgaris characterized by the following:
- •IGA Score >3 10-50 facial inflammatory lesions (papules,pustules) 10-100 facial non-inflammatory lesions (open/closed comedones)
- •Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA Authorization forms
排除标准
- •Female subjects who are pregnant (positive urine pregnancy test), breast feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- •Allergy/sensitivity to any component of the test treatment (Section 5.2), lincomycin, tetracyclines, or sulfites.
- •Subjects who have not complied with the proper wash-out periods for prohibited medications/procedures (Supplement 1)>
- •History of clinically significant anemia or hemolysis.
- •History of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis).
- •Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
- •Evidence of recent alcohol or drug abuse
- •Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
- •History of poor cooperation, non-compliance with medical treatment or unreliability
- •Participation in an investigational drug study within 30 days of the baseline visit.
研究组 & 干预措施
doxy + aczone
Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily and those who improve significantly are continued on Aczone gel alone to see if it can maintain therapeutic response
干预措施: Doxycycline 100mg (Drug)
doxy + aczone
Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily and those who improve significantly are continued on Aczone gel alone to see if it can maintain therapeutic response
干预措施: Aczone 5% gel (Drug)
结局指标
主要结局
Percentage of Participants Who Remained Responders at Week 24
时间窗: Assessed every 4 weeks, reported at Week 24
At week 12 responder had an IGA \<3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained
次要结局
- Peeling(every four weeks)
- Percentage of Participants Who Are Responders at Week 16 and 20(Assessed every 4 weeks, reported at weeks 16 and 20)
- Nodule Counts(every four weeks)
- Dryness(every 4 weeks)
- Erythema(every 4 weeks)
- Pruritis(every 4 weeks)
- Inflammatory and Non-inflammatory Lesion Counts(Every 4 weeks)
- Oiliness(every 4 weeks)
- Burning(every 4 weeks)