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

Phase 4

Completed

• Conditions: Gene Expression; Cell Proliferation; Wound Healing
• Interventions: Drug: Placebo; Drug: Dexpanthenol (BAY81-2996)

• Registration Number: NCT00859196
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	Dexpanthenol (BAY81-2996)	-

Primary Outcome Measures

Name	Time	Method
Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level.	Analysis of skin biopsies taken 24h, 72h and 144h after wounding