A single centre open-label study to evaluate the tolerability and safety of a synthetic injectable soft tissue implant material (Family C Matrix) in the skin of normal volunteers.
- Conditions
- Tolerability & safety of a new synthetic soft tissue implant material.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12608000003370
- Lead Sponsor
- Cosmetrend Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 14
1. Participants 18 years of age or older, male or female, in generally good health.
2. Participants willing and able to comply with the requirements of the study.
3. Participants willing and able to comply with the follow-up requirements.
4. Participants willing and able to give informed consent.
5. Females must be post-menopausal, surgically sterile or willing to use a
medically acceptable form of birth control during the study. Males must be
sterile, surgically sterile or willing to use a medically acceptable form of birth
control during the study
1. Participants who are pregnant, nursing or intend to become pregnant during the
study period.
2. Participants who were or are currently being treated with any systemic
immunosuppressive therapy including but not limited to chemotherapy agents or
corticosteroids within the past 3 months. The use of stable doses of inhaled or
nasal corticosteroids is acceptable.
3. Participants who were or are currently being treated with any topical OTC drug or
prescription therapy on their proximal arm test area within the past 3 months.
4. Participants with skin findings or disease in the proposed implant area that could
confound the interpretation of the reactivity of the implant sites.
5. Participants with a history indicative of abnormal immune function (e.g. autoimmune
diseases, HIV, cancer [other than non-melanoma skin cancer], etc.)
6. Participants with known sensitivity to any of the Test Article materials.
7. Participants with severe allergies manifested by a history of anaphylaxis.
8. Participants are currently enrolled in an investigational drug or device study.
9. Participants have received an investigational drug or treatment with an
investigational device within 30 days prior to entering this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety endpoints. The number and percentage of participants who develop a positive response to the implants. In addition histologic events and adverse events will be summarised.[Baseline Day 1. Days 30, 60, 90, 180, 270, 360 - any two randomly assigned. Two implants (approximately 0.1 cc each) of the Matrix C Gel implant material<br>will be placed in the right or left proximal arm per protocol. All participants<br>enrolled in the study will be randomly assigned to two time points for biopsy<br>evaluation of the implant material prior to placement. A randomization listing provided by the Sponsor will identify the two time points and the specific site for<br>biopsy evaluation]
- Secondary Outcome Measures
Name Time Method il[Nil]