EUCTR2012-002863-88-ES进行中（未招募）不适用
A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas with Actinic Keratosis on Face/Scalp and Trunk/Extremities
EO PHARMA A/S0 个研究点目标入组 200 人开始时间: 2012年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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, 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 face or scalp.
- •3.Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities.
- •4.Subject at least 18 years of age.
- •5.Female subjects must be of either:
- •a.Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
- •b.Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.
- •6.Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
- •Effective contraception is defined as follows:
- •- Oral/implant/injectable/transdermal/oestrogenic vaginal ring contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide.
- •- Abstinence or partner?s vasectomy are acceptable if the female agrees to implement one of the other acceptable methods of birth control if her partner changes.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.Location of the selected treatment areas:
- •?on the periorbital skin,
- •?within 5 cm of an incompletely healed wound,
- •?within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- •2.Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities.
- •3.Lesions in the selected treatment areas that have:
- •?atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or,
- •?recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
- •4.History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum).
- •5.Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas.
- •6.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.
- •7.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 (see Exclusion Criteria Nos. 14-21).
- •8.Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel.
- •9.Presence of sunburn within the selected treatment areas.
- •10.Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
- •11.Subjects previously randomised in the trial.
- •12.Female subjects who are breastfeeding.
- •13.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).
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A Simultaneous Treatment Regimen Compared to a Sequential TreatmentRegimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas withActinic Keratosis on Face/Scalp and Trunk/ExtremitiesMedDRA version: 14.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersActinic KeratosisEUCTR2012-002863-88-ITEO PHARMA A/S200
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