NCT00859105已完成3 期
A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Apotex Inc.
- 入组人数
- 497
- 主要终点
- The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
研究概览
简要总结
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
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
- 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
Adara 5 % Cream US
Active Comparator
Manufactured by 3M, US.
干预措施: Adara 5% Cream US (Drug)
Adara 5% Cream Canada
Active Comparator
Manufactured by 3M, Canada
干预措施: Adara 5% Cream Canada (Drug)
Vehicle
Placebo Comparator
Manufactured by Apotex
干预措施: Imiquimod Vehicle (Drug)
结局指标
主要结局
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
时间窗: 24 weeks
次要结局
- The secondary objective is to compare the safety profiles of the three creams.(24 weeks)
研究者
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