Effectiveness and Safety Study of Overnight Intensive Patch in Scars

Merz Pharmaceuticals

Status: Completed

Conditions: Post Dermatological Surgery Scars

Treatments: Device: Overnight Intensive Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01910896

MRZ90011_0028_3

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

Overnight Intensive Patch

Experimental group

Description:

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.

Treatment:

Device: Overnight Intensive Patch

No treatment

No Intervention group

Description:

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.