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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
Placebo to Bepanthen® ointment without active ingredient dexpanthenol
Unnamed facility
Hamburg, Free and Hanseatic City of Hamburg, Germany
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%
Time frame: At Day 5
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
Time frame: At Days 15 and 36
Number of participants with adverse events
Time frame: Approximately 5 weeks per subject
Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction
Time frame: At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15
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