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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859196
• Other study ID #: 13069
• Secondary ID: 2008-002069-30
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2009
• Last updated: December 8, 2014
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cell Proliferation
• Gene Expression
• Wound Healing

Intervention

Drug:
• Dexpanthenol (BAY81-2996)
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.
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

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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