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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005508-14 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexpanthenol | Experimental | A squeeze of ointment, approximately 0.5 cm in length corresponding to an amount of about 0.3 g of ointment, which is equal to 15 mg dexpanthenol , twice daily (once in the morning and once in the evening) over a period of 14 days was applied topically under occluded conditions |
|
| Placebo | Placebo Comparator | Subjects received applications of placebo corresponding to verum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996) | Drug | 30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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% | At Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Days 15 and 36 |
| Number of participants with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamburg | Free and Hanseatic City of Hamburg | 22869 | Germany |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| ID | Term |
|---|---|
| C007288 | dexpanthenol |
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| Placebo | Drug | Placebo to Bepanthen® ointment without active ingredient dexpanthenol |
|
| Approximately 5 weeks per subject |
| Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction | At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 |