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

NCT02734628 Phase 4 COMPLETED

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.

Details

Lead sponsor	Bayer
Phase	Phase 4
Status	COMPLETED
Enrolment	28
Start date	2007-03
Completion	2007-04

Conditions

• Wound Healing

Interventions

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

Primary outcomes

• Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo — At Day 5
  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%

Countries

Germany