EUCTR2016-000712-15-DE进行中（未招募）1 期
Double-blind, randomised clinical study comparing efficacy and safety of Imiquimod 5% Cream (Test) vs. Aldara® 5% Cream (Reference) vs. Vehicle in patients with actinic keratosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 426
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Women and men = 18 years of age
- •Written consent to study participation after patient information by the investigator
- •Diagnosis of actinic keratosis according to generally accepted criteria
- •Presence of a (connected) area of approximately 25 cm² on either the face or balding scalp which requires medical treatment.
- •Identification of at least 5 and no more than 10 delimitable target lesions in the treatment area which have the following properties: mild to moderate clinical severity (grading I or II according to Olsen et al. [1991], modified according to Stockfleth et al. [2008]), diameter = 4 mm, not hypertrophic, not massively hyperkeratotic
- •For women of childbearing potential : Application of an efficient contraceptive method during the whole study
- •For women of childbearing potential: Pregnancy test with negative result prior to study start
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 426
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis vulgaris, rosacea papulopustulosa, squamous cell carcinoma, or other possible confounding skin conditions in the treatment area.
- •Presence of hypertrophic or massively hyperkeratotic AK lesions in the treatment area with grading III (according to Olsen et al. [1991], modified according to Stockfleth et al. [2008])
- •Systemic therapy with retinoids within the last 6 months before study inclusion
- •Systemic treatment with immunosuppressive agents, interferon, glucocorticoids or cytostatics within the last 4 weeks prior to study treatment
- •Use of chemical peel, dermabrasion, laser abrasion, psoralen plus ultraviolet A (PUVA) therapy, and/or ultraviolet B (UVB) therapy in the treatment area in the last 6 months (180 days)
- •Use of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, masoprocol, or other treatments for AK in the treatment area in the last month (30 days)
- •Known intolerance or hypersensitivity against imiquimod or any of the other ingredients in the study medication
- •Other severe acute or chronic concomitant disease with severe impairment of the general condition
- •Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
- •Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
- •Reasonable doubt concerning the co-operation of the patient
- •Participation in another clinical study within the last 30 days prior to inclusion in this study
- •Participation in this study at an earlier date
- •Women with existing or intended pregnancy or during lactation
研究者
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