Status:
COMPLETED
Effectiveness and Safety Study of Overnight Intensive Patch in Scars
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Post Dermatological Surgery Scars
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01910896
Start Date
October 1 2013
End Date
July 1 2015
Last Update
September 9 2015
Active Locations (9)
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1
Merz Investigational Site # 0490341
Augsburg, Germany, 86179
2
Merz Investigational Site # 0490312
Berlin, Germany, 10117
3
Merz Investigational Site # 049307
Hamburg, Germany, 20354
4
Merz Investigational Site #0490345
Hamburg, Germany, 22609