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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
125
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.
Merz Investigational Site # 0490341
Augsburg, Germany
Merz Investigational Site # 0490312
Berlin, Germany
Merz Investigational Site # 049307
Hamburg, Germany
Merz Investigational Site #0490345
Hamburg, Germany
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?
Time frame: Baseline to week 12
Absolute change from screening/baseline in the total score of patient evaluated POSAS to week 12
Time frame: Baseline to week 12
Absolute change from screening/baseline in the total score of observer evaluated POSAS to week 24
Time frame: Baseline to week 24
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Merz Investigational Site # 0490101
Mahlow, Germany
Merz Investigational Site #0490340
Mainz, Germany
Merz Investigational Site # 049112
München, Germany
Merz Investigational Site # 049331
Münster, Germany
Merz Investigational Site # 0490321
Schweinfurt, Germany