check_circleStudy 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
  • - 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

  • - 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
15
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

StatusInstitutionLocation
Completed
proDermHamburg, 22869, Germany

Primary Outcome

  • Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level.
    date_rangeTime Frame:
    Analysis of skin biopsies taken 24h, 72h and 144h after wounding
    enhanced_encryption
    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
2

Additional Information

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