Wound Healing Clinical Trial
Official title:
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
In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a role during cell proliferating processes.The aim of this study is to investigate the molecular effect of Dexpanthenol on human living skin, during wound healing.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Skin type I to IV - Willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches 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 - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level. | Analysis of skin biopsies taken 24h, 72h and 144h after wounding | No |
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