A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%
研究概览
简要总结
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.
The secondary objective is to compare the adverse event (AE) profiles of the two creams.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
- •Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control
- •Free of any systemic or dermatological disorder
- •Any skin type or race, providing the skin pigmentation will allow discernment of erythema
排除标准
- •Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
- •History of cutaneous hyperreactivity or facial irritation to topical products
- •Engaging in activities involving excessive or prolonged exposure to sunlight
- •Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry
- •Currently using or have used systemic steroids 2 months prior to study
- •Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
- •Pregnant or nursing mothers
- •History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation
- •Taking immunosuppressant medication
研究组 & 干预措施
Imiquimod 5% Taro
Imiquimod 5% manufactured by Taro applied for 16 weeks
干预措施: Imiquimod 5% manufactured by Taro (Drug)
Aldara - Imiquimod 5%
Aldara, Imiquimod 5% applied for 16 weeks
干预措施: Aldara - Imiquimod 5% (Drug)
Vehicle
Imiquimod vehicle applied for 16 weeks
干预措施: Imiquimod Vehicle manufactured by Taro (Drug)
结局指标
主要结局
Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%
时间窗: 24 weeks
Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline
时间窗: 24 weeks
Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
次要结局
- Patients Reporting at Least One Adverse Event(24 weeks)