2024-515667-60-00招募中2 期
An exploratory, multicenter, randomized, open-label with blind evaluation, active-controlled study to evaluate the safety and efficacy of Keramod® (imiquimod 50 mg/g, Gel) compared with Aldara® (imiquimod 50 mg/g, Cream) for the treatment of actinic keratosis in adults.
Laboratorios Ojer Pharma S.L.5 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年9月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.
研究概览
简要总结
To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream), in the treatment of AK in terms of complete clearance of AK lesions at week 24 since the first treatment dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Entire trial period
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment área on either the face or balding scalp.
- •Man or woman aged over
- •Women either must be 1 year postmenopausal, surgically sterile, or agree to use a medically accepted form or birth control.
- •Free of any significant findings (e.g. tattoos) in the potential application site area.
- •Any skin type or race, providing the skin pigmentation will allow discernment.
- •Must be willing to comply with the contraception requirements as defined in Section 6.2.
- •Signature of the informed consent form.
- •Patients with the ability to understand and fulfil the study requirements.
- •In good health, as confirmed by medical history and physical examination, and free of any clinically significant disease/condition, other than actinic keratosis, that could interfere with the study evaluations.
排除标准
- •Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area.
- •Receiving immunosuppressive medication.
- •History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, mental, neurological or any other disease in the last 2 years prior to enrollment that could hinder regular treatment and supervision of the patient and could cause premature withdrawal of the study.
- •Mentally incapacitated patients.
- •Current history or history of drug or alcohol abuse in the last 3 years prior to enrollment.
- •Exposure to a product under investigation in the last 3 months prior to enrollment.
- •Known to be affected by porphyria.
- •Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area.
- •History of cutaneous hyperreactivity or 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.
- •Females who are pregnant, breastfeeding or planning to become pregnant during the first administration of IMP until 6 months after the last dose of IMP.
- •History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation.
结局指标
主要结局
Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.
Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.
次要结局
- 1. Partial and complete clearance rate of AK lesions at the end of first and second cycles: Week 8 (end of first cycle treatment period; visit 3) and Week 16 (end of second cycle treatment period; visit 5).
- 2. Tolerance and acceptability of the treatment by the study subject assessed by the Treatment tolerance and satisfaction questionnaire.
- 3. Evaluation of adherence by Treatment Adherence Questionnaire.
- 4. Rate of subjects who complete one treatment cycle.
- 5. Rate of subjects who complete two treatment cycles.
- 6. Severity and frequency of associated adverse events/serious adverse events (AEs/SAEs).
研究者
Clinical Development Manager
Scientific
Laboratorios Ojer Pharma S.L.
研究点 (5)
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