NCT02734628

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wound Healing

Interventions

Type	Name	Description
DRUG	Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)	30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
DRUG	Placebo	Placebo to Bepanthen® ointment without active ingredient dexpanthenol

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2016-04-12
• Last updated: 2016-04-12

Locations

1 site across 1 country: Germany