Effectiveness and Safety Study of Overnight Intensive Patch in Scars

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

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 Overview

• Status: Completed
• Conditions: Post Dermatological Surgery Scars
• Intervention / Treatment: Device: Overnight Intensive Patch

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86179
    • Merz Investigational Site # 0490341
  • Berlin, Germany, 10117
    • Merz Investigational Site # 0490312
  • Hamburg, Germany, 22609
    • Merz Investigational Site #0490345
  • Hamburg, Germany, 20354
    • Merz Investigational Site # 049307
  • Mahlow, Germany, 15831
    • Merz Investigational Site # 0490101
  • Mainz, Germany, 55131
    • Merz Investigational Site #0490340
  • München, Germany, 80337
    • Merz Investigational Site # 049112
  • Münster, Germany, 48157
    • Merz Investigational Site # 049331
  • Schweinfurt, Germany, 97421
    • Merz Investigational Site # 0490321

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has two or more newly formed post dermatological surgery scars of 1-10 (inclusive) cm each, with comparable length, located on a comparable skin area (upon the discretion of the investigator, considering e.g. the skin thickness or body tension). Scars located at the upper back of the body will not be investigated due to a higher risk of wound dehiscence.
• The dermatological surgery takes place within the last 3 weeks prior to baseline visit and the baseline visit is on the day of post-surgery control with optional suture removal, the wound must be closed by then.

Exclusion Criteria:

• Subject with known history of keloids or hypertrophic scars.
• Subject with derma resurfacing procedures or non-invasive skin-tightening procedures including medium/ deep chemical peeling, dermabrasion treatments or laser therapy in the skin area intended to be treated for less than 8 weeks prior to screening/ baseline visit.
• Subject with any planned topical application containing active ingredients (e.g. self-tanning agents, however, hydration lotion is allowed provided the scars are left free) in the skin area intended to be treated.
• Subject anticipated spending excessive time in the sun (e.g. outdoor workers) or in the sun tanning bed during the investigation.
• Subject with any infection or wound in the area intended to be treated.
• Subject with known hypersensitivity to any ingredient of OIP (e.g. acrylic adhesive, extractum cepae or allantoin).
• Subject who is taking, or anticipated to take during the investigation, systemic corticosteroids or topical corticosteroids applied on the investigation skin area.
• Subject with eczema requiring treatment in the skin area intended to be treated.
• Subject with any ongoing severe or uncontrolled systemic disease (cardiac, respiratory, hepatic, renal or gastrointestinal), malignant tumor (except for basalioma), or known HIV infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Overnight Intensive Patch; 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.	Device: Overnight Intensive Patch; 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.
No Intervention: No treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MRZ90011_0028_3