EUCTR2008-002069-30-DE进行中（未招募）不适用
A randomized, double-blind, single centre, placebo-controlled pilot study to assess on a molecular level the influence of a 5 % dexpanthenol ointment in subjects with previously injured skin by investigation of skin biopsies
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Male or female Caucasian
- •Age 18 to 45
- •Skin type I to IV
- •Willingness to actively participate in the study and to comply with the study procedures as defined in the study protocol
- •Willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches
- •Signed written informed consent
- •Negative urine pregnancy test (in female subjects of childbearing potential)
- •reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner)
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring
- •History of keloids and hypertrophic scars
- •History of plaster sensitivity
- •Frequent visits of tanning booths
- •Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 30 days before day 1 as well as during the study.
- •Concomitant therapy with substances affecting blood coagulation (e.g. acetylsalicylic acid, anticoagulants, diuretics) within up to 14 days prior to the start of the study as well as during the study
- •Any condition or treatment (within 14 days prior to the start as well as during the study) which might influence the study (e.g. diabetes, dysfunction of blood clotting)
- •Change of hormonal contraception within 3 months prior to enrolment and during the study
- •Allergy to the ingredients of the test product
- •Pregnancy or lactation
- •Any illness on account of which the subject should not participate in the study in the opinion of the investigator
- •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
- •Any history of drug addiction or alcoholism in the past 3 years
- •Infectious diseases (e.g. hepatitis or AIDS)
- •If in the opinion of the investigator the subject should not participate in the study for any reason
- •Participation in a clinical trial within the last 30 days prior to enrolment
- •Employees of the study sites or of the Sponsors company
研究者
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