EUCTR2012-002863-88-IT进行中（未招募）不适用
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/Extremities
EO PHARMA A/S0 个研究点目标入组 200 人开始时间: 2012年12月11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: 0
- •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).
研究者
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