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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


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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