Pilot Study to Assess Number of Patients for Main Trial

A Randomized, Double-blind, Single Center, Intra-individual Comparison Study With Repeated Application to Assess the Wound-healing Efficacy of a 5% Dexpanthenol Ointment Compared With Placebo in Patients With Superficial, Abrasive Wounds

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22869

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996); 30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
Placebo Comparator: Placebo; Subjects received applications of placebo corresponding to verum	Drug: Placebo; Placebo to Bepanthen® ointment without active ingredient dexpanthenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo	Wound healing effect (=re-epithelization) was determined on the following basis: No healing 0% Re-epithelization >0 up to 25% Re-epithelization >25 up to 50% Re-epithelization >50 up to 75% Re-epithelization >75 but not complete Complete closure of surface 100%	At Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective assessment of cosmetic outcome	It was assessed by using a visual analog scale (VAS) ranging from 0 being poor, 5 being moderate to 10 being excellent	At Days 15 and 36
Number of participants with adverse events		Approximately 5 weeks per subject
Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction		At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 12, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 12631; 2006-005508-14 (EudraCT Number)