Epidermal abrasive wounds
Conditions
Interventions
Trade Name: Bepanthen Wund- und Heilsalbe
Product Name: Bepanthen Wund- und Heilsalbe
Pharmaceutical Form: Cutaneous emulsion
INN or Proposed INN: DEXPANTHENOL
CAS Number: 81130
Current Sponsor code:
Sponsors
Bayer Consumer Care AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Re-epithelization day 5;Secondary Objective: - Re-epithelization day 2, 3, 4, 6, 7, 8, 9, 10, and 15 - assessment of cosmetic outcome/acceptance day 36 - documentation and analysis of safety parameters;Primary end point(s): Re-epithelization day 5 | — |
Countries
Germany
Outcome results
None listed