Pilot Study to Assess Number of Patients for Main Trial

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Wound Healing

Intervention / Treatment
-----------------
* Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexpanthenol<br>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)<br>* 30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment<br>|
| Placebo Comparator: Placebo<br>Subjects received applications of placebo corresponding to verum | Drug: Placebo<br>* Placebo to Bepanthen® ointment without active ingredient dexpanthenol<br>|

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 |