Clinical trial NCT01910896: Effectiveness and Safety Study of Overnight Intensive Patch in Scars
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Dermatological Surgery Scars
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change from screening/baseline in the total score of observer evaluated POSAS [Patient and Observer Scar Assessment Scale] to week 12
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Absolute change from screening/baseline in the total score of patient evaluated POSAS to week 12
timeFrame: Baseline to week 12
measure: Absolute change from screening/baseline in the total score of observer evaluated POSAS to week 24
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Merz Investigational Site # 0490341
city: Berlin
country: Germany
facility: Merz Investigational Site # 0490312
city: Hamburg
country: Germany
facility: Merz Investigational Site # 049307
city: Hamburg
country: Germany
facility: Merz Investigational Site #0490345
city: Mahlow
country: Germany
facility: Merz Investigational Site # 0490101
city: Mainz
country: Germany
facility: Merz Investigational Site #0490340
city: München
country: Germany
facility: Merz Investigational Site # 049112
city: Münster
country: Germany
facility: Merz Investigational Site # 049331
city: Schweinfurt
country: Germany
facility: Merz Investigational Site # 0490321
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: