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

NCT ID: NCT00859196

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Healing Cell Proliferation Gene Expression

Keywords

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Wound healing Cell proliferation Gene expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Dexpanthenol (BAY81-2996)

Intervention Type DRUG

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.

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Hamburg, City state of Hamburg, Germany

Site Status

Countries

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Germany

Related Links

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http://www.clinicaltrialsregister.eu

Click here and search Bayer product information provided by the EMA

Other Identifiers

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2008-002069-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13069

Identifier Type: -

Identifier Source: org_study_id