Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Wound Healing, Cell Proliferation, Gene Expression

Intervention / Treatment
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* Drug: Dexpanthenol (BAY81-2996)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Dexpanthenol (BAY81-2996)<br>* Test product and the respective placebo will be applied to previously wounded test areas and the surrounding skin (approx. 3 cm2). After a certain time the second skin biopsy will be taken from the treated test areas. The skin biopsies will be analysed via micro array.<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Test product and the respective placebo will be applied to previously wounded test areas and the surrounding skin (approx. 3 cm2). After a certain time the second skin biopsy will be taken from the treated test areas. The skin biopsies will be analysed via micro array.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level. |  | Analysis of skin biopsies taken 24h, 72h and 144h after wounding | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound healing, Cell proliferation, Gene expression