ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Treatment Success at End of Study Visit
研究概览
简要总结
The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter.
- •Age 30-85 years, inclusive.
- •Good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
排除标准
- •Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease.
- •Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism.
- •Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within 180 days prior to the Baseline Visit.
- •Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.
研究组 & 干预措施
ACT01 plus Comp03
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
干预措施: ACT01 (Drug)
ACT01 plus Comp03
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
干预措施: Comp03 (Drug)
ACT01 plus Comp01
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
干预措施: ACT01 (Drug)
ACT01 plus Comp01
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
干预措施: Comp01 (Drug)
ACT01 plus Comp02
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
干预措施: ACT01 (Drug)
ACT01 plus Comp02
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
干预措施: Comp02 (Drug)
ACT01 plus Comp04
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
干预措施: ACT01 (Drug)
ACT01 plus Comp04
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
干预措施: Comp04 (Drug)
结局指标
主要结局
Treatment Success at End of Study Visit
时间窗: up to Day 57
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
次要结局
- Irritation Score(up to Day 57)