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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN35051281 |
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Date of registration:
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31/07/2009 |
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Primary sponsor: |
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Public title:
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Subdermal implantation of the collagen-elastin-matrix Matriderm® to improve profile and skin structure of degenerative changes in the midface region [Subkutaner einsatz der kollagen-elastin-matrix Matriderm® zur verbesserung von profil und hautstruktur bei degenerativen veränderungen des mittelgesichtes]
SIMAMID II |
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Scientific title:
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Subdermal implantation of the collagen-elastin-matrix Matriderm® to improve profile and skin structure of degenerative changes in the midface region: a non-randomised single arm clinical trial |
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Date of first enrolment:
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May 15 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN35051281 |
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Study type:
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Interventional |
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Study design:
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Non-randomised single-arm clinical trial
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Countries of recruitment
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Germany
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Contacts
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Name:
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Henrik
Menke |
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Address:
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Klinik für Plastische-, Ästhetische- und Handchirurgie
Schwerbrandverletztenzentrum
Starkenburgring 66
63069
Offenbach
Germany |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy adults aged 40 - 65 years, either sex
Exclusion criteria: 1. Severe allergies
2. Severe acute or chronic diseases
3. Skin infections
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Degenerative structure of profile and/or skin quality in the mid-face, caused by disease or ageing
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Intervention(s)
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Step 1: Subdermal laminar implantation of a collagen-elastin-matrix on the upper arm
Step 2: Subdermal laminar implantation of a collagen-elastin-matrix on the mid-face region
Skin biopsies (upper arm) before, 6 and 12 months post-operatively.
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Primary Outcome(s)
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Clinical outcome of mid-face region, measured at month 8 after step 1 (upper arm).
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Secondary Outcome(s)
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Clinical, histological and cutometric outcome upper arm, measured at month 14 after step 1 (upper arm).
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Secondary ID(s)
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DE/CA22/2-2008/KLP
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Source(s) of Monetary Support
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Dr Suwelack Skin and Health Care AG (Germany)
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