Condition category
Skin and Connective Tissue Diseases
Date applied
15/05/2009
Date assigned
31/07/2009
Last edited
31/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henrik Menke

ORCID ID

Contact details

Klinik für Plastische-
Ästhetische- und Handchirurgie
Schwerbrandverletztenzentrum
Starkenburgring 66
Offenbach
63069
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DE/CA22/2-2008/KLP

Study information

Scientific title

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

Acronym

SIMAMID II

Study hypothesis

Collagen matrices are in clinical use in plastic and burn surgery under split skin for dermal regeneration; in this study we investigate the effects of subdermal implantation of the matrix under healthy skin on mid-face profile, skin quality and dermal architecture.

Ethics approval

The local ethics committee (Ethik-Kommission bei der Landesärztekammer Hessen) approved on the 4th June 2008 (ref: FF 29/2008)

Study design

Non-randomised single-arm clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Degenerative structure of profile and/or skin quality in the mid-face, caused by disease or ageing

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Matriderm®

Primary outcome measures

Clinical outcome of mid-face region, measured at month 8 after step 1 (upper arm).

Secondary outcome measures

Clinical, histological and cutometric outcome upper arm, measured at month 14 after step 1 (upper arm).

Overall trial start date

15/05/2008

Overall trial end date

14/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults aged 40 - 65 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Severe allergies
2. Severe acute or chronic diseases
3. Skin infections

Recruitment start date

15/05/2008

Recruitment end date

14/11/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik für Plastische-, Ästhetische- und Handchirurgie
Offenbach
63069
Germany

Sponsor information

Organisation

Dr Suwelack Skin and Health Care AG (Germany)

Sponsor details

Josef-Suwelack-Strasse
Billerbeck
48727
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Dr Suwelack Skin and Health Care AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes