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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00859196
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Days): 28
• Patients Per Site Per Month: 16.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Healing; Cell Proliferation; Gene Expression	Drug: Dexpanthenol (BAY81-2996); Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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 Comparator: Arm 2	Drug: 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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hamburg		Germany	22869

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here and search Bayer product information provided by the EMA

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00859196
• Other Study ID Numbers: 13069; 2008-002069-30
• First Posted: Mar 10, 2009
• Last Update Posted: Dec 9, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Wound healing; Cell proliferation; Gene expression

Study Results

No Results Posted as of Dec 9, 2014