Pilot Study to Assess Number of Patients for Main Trial

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-04-30

Brief Summary

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The objective of the study was to investigate the efficacy of Bepanthen® wound healing ointment compared to placebo in a superficial abrasive wound model. The primary objective was the re-epithelization at Day 5.

The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15, assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36 (investigator and subject), and documentation and analysis of safety parameters.

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Detailed Description

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Conditions

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Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexpanthenol

A squeeze of ointment, approximately 0.5 cm in length corresponding to an amount of about 0.3 g of ointment, which is equal to 15 mg dexpanthenol , twice daily (once in the morning and once in the evening) over a period of 14 days was applied topically under occluded conditions

Group Type EXPERIMENTAL

Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)

Intervention Type DRUG

30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment

Placebo

Subjects received applications of placebo corresponding to verum

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to Bepanthen® ointment without active ingredient dexpanthenol

Interventions

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Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)

30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment

Intervention Type DRUG

Placebo

Placebo to Bepanthen® ointment without active ingredient dexpanthenol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV

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
* History of plaster sensitivity
* Intake of drugs interfering with the immune system within 30 days before day 1 as well as during the study
* Concomitant therapy with substances affecting blood coagulation within up to 14 days prior to the start of the study as well as during the study
* Any condition or treatment which might influence the study
* Change of hormonal contraception within 3 months prior to enrolment and during the study
* Application of any topical treatment at the test areas during the conduct of the study
* Intensive ultraviolet-light exposure within two weeks before the beginning as well as during the study
* Removal of axillary lymph nodes
* Allergy to the ingredients of the test product
* Pregnancy or lactation
* Any illness on account of which the subject should not participate in the study in the opinion of the investigator
* Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
* Any history of drug addiction or alcoholism in the past 3 years
* Infectious diseases (e.g. hepatitis or AIDS)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes