Biopsy wounds on healthy volunteers
Conditions
Interventions
Trade Name: Bepanthen Wund- und Heilsalbe
Product Name: Bepanthen Wund- und Heilsalbe
Pharmaceutical Form: Ointment
INN or Proposed INN: Dexpanthenol
CAS Number: 81130
Current Sponsor code: BAY81-2996
Sponsors
Bayer Vital GmbH
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 •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
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 •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to analyse the efficacy of pantothenate on wound healing by investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level involved in skin proliferation after wounding of the skin and three different numbers of applications.;Secondary Objective: ;Primary end point(s): The investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level involved in skin proliferation after wounding of the skin and three different numbers of applications. In the gene-level expression analysis, multiple probes on different exons are summarized into an expression value of all transcripts from the same gene. The major focus of the investigation will be on proliferation stimulating genes, on anti-apoptotic genes and genes for the regulation of anti-inflammatory mediators. | — |
Countries
Germany
Outcome results
None listed