Trial Condition(s):

Wound Healing

Pilot study to assess number of patients for main trial

Bayer Identifier:

12631

ClinicalTrials.gov Identifier:

NCT02734628

EudraCT Number:

2006-005508-14

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
28
Trial Dates
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Phase
4
Could I receive a placebo?
Yes
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

proDerm

Hamburg, Germany, 22869

Status
Completed
 

Trial Design