Overnight Intensive Patch
DeviceEligible 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.
NCT Number: NCT01910896
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Merz Investigational Site # 0490341, Augsburg, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline 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
Time frame: Baseline to week 24
Merz Pharmaceuticals GmbH
Industry
A Prospective, Intra-individual Randomized, Observer-blind, Controlled Investigation to Investigate the Effectiveness and Safety of Overnight Intensive Patch (OIP) Over 12 to 24 Weeks in Post Dermatological Surgery Scars
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.