DRKS00007918已完成1 期
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment with Ingenol Mebutate Gel, 0.05%A phase 1 trialA multi-centre, single arm, open-label, 8-week trial
EO Pharma GmbH0 个研究点目标入组 110 人开始时间: 2015年4月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
研究概览
简要总结
The observed agreement between the clinical- and the two pathologists’ histological assessment in clearance of single AK was 81.9%. Most AK lesions treated with ingenol mebutate had clearance of single AK at Week 8: 85.2% according to the clinical assessment, 81.5% and 80.6% according to the pathologists’ histology assessments. Ingenol mebutate treatment was generally well tolerated and no safety concerns were identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Following verbal and written information about the
- •trial, subject must provide informed consent documented
- •by signing the Informed Consent Form (ICF)
- •prior to any trial-related procedures
- •2. Subjects with 5-9 clinically typical, visible and
- •discrete AKs within a contiguous 25 cm2 treatment
- •areas on the trunk and extremities except the back of
- •3. Actinic keratosis should be confirmed by histopathology
- •of one of the AKs prior to inclusion.
排除标准
- •1. Selected treatment areas:
- •within 5 cm of an incompletely healed wound
- •within 10 cm of a suspected basal cell carcinoma
- •(BCC) or squamous cell carcinoma (SCC)
- •2. Selected treatment area lesions that have atypical
- •clinical appearance (e.g., hypertrophic, hyperkeratotic
- •or cutaneous horn).
- •3. 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).
- •4. Use of cosmetic or therapeutic products and procedures
- •which could interfere with the assessments of
- •the treatment area
- •5. 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.
- •6. Anticipated need for hospitalisation or out-patient
- •surgery during the first 15 days after the first trial
- •medication application. Note that cosmetic/
- •therapeutic procedures are not excluded if they
- •fall outside of the criteria detailed in Prohibited
- •Therapies or Medications
- •7. Known sensitivity or allergy to any of the ingredients
- •in ingenol mebutate gel
- •8. Presence of sunburn within the selected treatment
- •9. Current enrolment or participation in any other
- •interventional clinical trial within 30 days of entry
- •into this trial.
- •10. Subjects previously enrolled in this trial.
- •11. Female subjects who are breastfeeding.
- •12. Subjects who are institutionalised by court order
- •13. In the opinion of the investigator, the subject is
- •unlikely to comply with the Clinical Study Protocol
研究者
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