Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries
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
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 9, 2009
CompletedFirst Posted
Study publicly available on registry
March 10, 2009
CompletedDecember 9, 2014
December 1, 2014
Same day
March 9, 2009
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level.
Analysis of skin biopsies taken 24h, 72h and 144h after wounding
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Hamburg, Hamburg, 22869, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2009
First Posted
March 10, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2009
Study Completion
March 1, 2009
Last Updated
December 9, 2014
Record last verified: 2014-12