NCT00110682已完成4 期
A Randomized, Parallel-Group, Vehicle-Controlled, Double-Blind Study of Topical Imiquimod 5% Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses, With a Long-Term (1 Year) Follow-Up
Derm Research @ 888 Inc.5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Recurrence rate and time to recurrence of lesions
研究概览
简要总结
Study Aims:
- To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy.
- To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.
详细描述
Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy.
Study Aims:
- To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
- To assess and compare the efficacy of the 2 different treatment groups.
- To assess and compare the safety of the 2 different treatment groups.
Study Design: 6 visits over 62 weeks
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
- Double
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
- •Diagnosis of actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2)
- •Women of childbearing potential using appropriate contraceptive methods
排除标准
- •Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks.
- •Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study.
- •Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.
结局指标
主要结局
Recurrence rate and time to recurrence of lesions
次要结局
- Time to reach treatment success
- Percentage of patients who clear
- Patient improvement assessment
研究者
研究点 (5)
Loading locations...
相似试验
已完成
4 期
Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and HandsKeratosisNCT00115154Graceway Pharmaceuticals, LLC270
已完成
2 期
A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant RecipientsActinic KeratosisNCT00189267MEDA Pharma GmbH & Co. KG45
已完成
1 期
Bioequivalence Study of Two Imiquimod Cream 5%Actinic KeratosisNCT00828568Taro Pharmaceuticals USA425
已完成
3 期
A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic KeratosesActinic KeratosisNCT02120898Actavis Inc.467
Unknown
3 期
Imiquimod Treatment of Residual or Recurrent CIN Lesions: a Study ProtocolCervical Intraepithelial NeoplasiaNCT02669459Erasmus Medical Center433