EUCTR2014-003218-98-ES进行中（未招募）1 期
Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp. - Not applicable
EO Pharma A/S0 个研究点目标入组 500 人开始时间: 2015年3月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- 性别
- All
入选标准
- •1.Following verbal and written information about the trial, the subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
- •2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. Location of the selected treatment area:
- •? on the periorbital skin
- •? on the perioral skin/around the nostrils
- •? within 5 cm of an incompletely healed wound
- •? within 10 cm of a suspected BCC or SCC or other neoplasia
- •2. Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn) or recalcitrant disease (e.g., did not respond to AK treatment in the previous)
- •3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatmentarea
- •4. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
- •5. Use of ingenol mebutate and/or diclofenac sodium in and within 5 cm of the selected treatment area within the last 12 months prior to Visit 1
- •6. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment area
- •7. Known or suspected hypersensitivity or allergy to any of the ingredients in ingenol mebutate gel or diclofenac sodium gel
- •8. Organ transplant recipients
- •9. Immunosuppressed subjects (for example HIV patients)
- •10. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator?s clinical judgment
- •11. Presence of acute sunburn within the selected treatment area
- •12. Current enrolment or participation in a clinical trial within 30 days of entry into this
- •13. Subjects previously randomised in the trial
- •14. Female subjects who are breastfeeding
- •15. Subjects who are institutionalized by court order or by the local authority
- •16. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
研究者
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