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To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of post dermatological surgery scars and its safety over 12 to 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overnight Intensive Patch | Experimental | Overnight intensive patch (OIP), on polyolefin foam basis containing acrylate, extractum cepae and allantoin is a class I, CE (Conformité Européenne) marked medical device. Subjects will have their two scars randomized for Overnight Intensive Patch application versus no treatment. |
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| No treatment | No Intervention | Subjects serve as their own control. Eligible subjects have two comparable scars in same body regions, one scar will be treated with Overnight Intensive Patch, the second scar will not be treated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overnight Intensive Patch | Device | Eligible subjects will have their two scars randomized for OIP application/no treatment. OIP for overnight application (at least 6 hours) for 12 to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from screening/baseline in the total score of observer evaluated POSAS [Patient and Observer Scar Assessment Scale] to week 12 | The POSA scale consists of two scales which need to be filled out by the observer and the subject, respectively. The scale will be rated for both scars of the same subject by observer and the subject independently in all planned visits. Observer Scar Assessment: The observer assesses the following items on a scale from 1 (normal skin) to 10 (worst imaginable skin): Vascularization, Pigmentation, Thickness, Relief, Pliability. Patient Scar Assessment: The subject answers the following questions on a scale from 1 (no, no complaints) to 10 (yes, worst imaginable): Is the scar painful?, Is the scar itching?; The subject answers the following questions on a scale from 1 (no, as normal skin) to 10 (yes, very different): Is the color of the scar different?, Is the scar more stiff?, Is the thickness of the scar different?, Is the scar irregular? | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from screening/baseline in the total score of patient evaluated POSAS to week 12 | Baseline to week 12 | |
| Absolute change from screening/baseline in the total score of observer evaluated POSAS to week 24 | Baseline to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site # 0490341 | Augsburg | 86179 | Germany | |||
| Merz Investigational Site # 0490312 |
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| Berlin |
| 10117 |
| Germany |
| Merz Investigational Site # 049307 | Hamburg | 20354 | Germany |
| Merz Investigational Site #0490345 | Hamburg | 22609 | Germany |
| Merz Investigational Site # 0490101 | Mahlow | 15831 | Germany |
| Merz Investigational Site #0490340 | Mainz | 55131 | Germany |
| Merz Investigational Site # 049112 | München | 80337 | Germany |
| Merz Investigational Site # 049331 | Münster | 48157 | Germany |
| Merz Investigational Site # 0490321 | Schweinfurt | 97421 | Germany |