NCT07513454尚未招募2 期
A Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HW211026 Ointment in Patients With Actinic Keratosis.
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete Clearance Rate
研究概览
简要总结
This is a multicenter, randomized, open-label, parallel-group, Phase II clinical trial designed to evaluate the efficacy and safety of HW211026 in adult patients with actinic 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years, male or female.
- •2 to 8 clinically typical target actinic keratosis lesions on the face.
- •Willing to avoid direct sun or ultraviolet exposure to the treatment area during the trial.
- •Fully informed about the study, voluntarily sign the informed consent form, and be able to comply with study procedures and follow-up examination requirements.
排除标准
- •Target lesions with any of the following conditions: 1) Clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns. 2) Maximum diameter of a single lesion > 2 cm. 3) Concurrent invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma or other malignant tumors. 4) Other skin diseases or skin conditions that may interfere with examination or lesion assessment.
- •Presence of incompletely healed wounds or suspected squamous cell carcinoma, basal cell carcinoma, or other malignant tumors within 5 cm of the actinic keratosis lesions.
- •Participants with other skin diseases or skin conditions that, in the investigator's judgment, may interfere with the evaluation of safety or efficacy.
- •Participants who have undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial, as determined by the investigator.
- •Participants who have participated in any investigational drug clinical trial and received an investigational product within 3 months prior to screening.
研究组 & 干预措施
HW211026 dose 1
Experimental
干预措施: HW211026 (Drug)
HW211026 dose 2
Experimental
干预措施: HW211026 (Drug)
结局指标
主要结局
Complete Clearance Rate
时间窗: Day 56
Percentage of participants achieving 100% clearance of actinic keratosis lesions.
次要结局
- Change from baseline in lesion counts(Days 14, 28, 42 and 56)
- The number and severity of treatment emergent adverse events (TEAEs)(Baseline up to Day 57)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Homozygous Familial HypercholesterolemiaNCT07591298CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.18
招募中
2 期
Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLCNCT07398937Fudan University116
尚未招募
2 期
Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal CarcinomaNCT07388836Fujian Cancer Hospital198
招募中
2 期
IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction AdenocarcinomaNCT07483567Innovent Biologics (Suzhou) Co. Ltd.90
尚未招募
2 期
SYS6002 vs PADCEV in Patients With Advanced Urothelial CarcinomaNCT07374549CSPC Megalith Biopharmaceutical Co.,Ltd.100