CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Oleogel-S10 ointment +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01657292
NCT01657292Phase 3Completed

Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds

Birken AG·interventional·Posted Aug 6, 2012·Updated Sep 28, 2015

In Brief

A Phase 3 clinical trial evaluating Oleogel-S10 ointment and Octenilin® wound gel for Burns. Completed, enrolled 61 participants across 9 sites in 4 countries.

Detailed Summary

The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesGermany, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2012
Enrollment StartAug 1, 2012
Primary CompletionJul 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.9 years ago

Interventions

Oleogel-S10 ointmentdrug

Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing

Octenilin® wound geldevice

Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing