Study Completed

Wound healing, Cell proliferation, Gene expression

Bayer Identifier:

13069

ClinicalTrials.gov Identifier:

NCT00859196

EudraCT Number:

2008-002069-30

EU CT Number:

Not Available

Study to assess on a molecular level the influence of a 5 % dexpanthenol ointment in subjects with superficial injuries

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 45 Years

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.

Trial summary

Enrollment Goal

Trial Dates

February 2009 - March 2009

Phase

Phase 4

Could I Receive a placebo

Yes

Products

Dexpanthenol (BAY81-2996)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	proDerm	Hamburg, 22869, Germany

Primary Outcome

Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level.
Time Frame:
Analysis of skin biopsies taken 24h, 72h and 144h after wounding
Safety Issue:
no

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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