A randomized, , double-blind, single centre, intra-individual comparison study with repeated application to assess the wound-healing efficacy of a 5 % Dexpanthenol ointment compared with placebo in patients with superficial, abrasive wounds.
- Conditions
- Epidermal abrasive wounds
- Registration Number
- EUCTR2006-005508-14-DE
- Lead Sponsor
- Bayer Consumer Care AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• 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
• Signed written informed consent
• Negative urine pregnancy test (in female subjects of childbearing potential)
• For female subjects of childbearing potential: use of a reliable contraceptive method (e.g. contraceptive pills, intrauterine contraceptive device, implants).
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
• 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
• 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
• Application of any topical treatment (e.g. moisturizers, sun protection) at the test areas during the conduct of the study (until day 36)
• Intensive UV-light exposure within two weeks before the beginning as well as during the study
• Removal of axillary lymph nodes
• 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
• Any history of drug addiction or alcoholism in the past 3 years
• Infectious diseases (e.g. hepatitis or AIDS)
• Participation in a clinical trial within the last 30 days prior to enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Re-epithelization day 5;Secondary Objective: - Re-epithelization day 2, 3, 4, 6, 7, 8, 9, 10, and 15<br>- assessment of cosmetic outcome/acceptance day 36<br>- documentation and analysis of safety parameters;Primary end point(s): Re-epithelization day 5
- Secondary Outcome Measures
Name Time Method