Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000003370
Ethics application status
Approved
Date submitted
20/12/2007
Date registered
7/01/2008
Date last updated
20/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 287951 0
NIL Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tolerability & safety of a new synthetic soft tissue implant material. 2654 0
Condition category
Condition code
Other 2772 2772 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tolerability & safety of a new synthetic soft tissue implant material consisting of Family C microspheres in hyaluronic acid carrier in the skin of healthy volunteers. The Family C implant is a thermoplastic block copolymer produced from two long-chain methacrylic aliphatic esters and one short-chain acrylic aliphatic ester. At body temperature, the material is an elastomeric solid. The Family C test article proposed will be the same material currently under evaluation per protocol D73-2602-07, yet will be provided in a microsphere form, suspended in hyaluronic acid (HA), and injected into the dermis. The implants will be delivered via a standard syringe and needle, with the assistance of an additional investigational syringe driver device. This Family C co-polymer material is now being proposed for evaluation as an injectable matrix for use in soft tissue repair or augmentation. The material is presented as microspheres in a suspension of HA. At Screening Visit (up to 30 days before Visit 1), participants will be evaluated for eligibility per the inclusion/exclusion criteria and review of their medical and dermatological history. Eligible and willing participants will review and sign the informed consent form. At Baseline – Treatment Visit 1 (Day 1), participants from whom a signed, written informed consent has been obtained and study eligibility confirmed, will be designated to receive implantation with the Test Article. Each participant will be randomly assigned to two time points for biopsy evaluation (Day 30, 90, 180, 270 or 360) of the implant material prior to placement. Two implants (~ 0.1cc) will be administered intradermally within the designated region of the inner aspect of their proximal forearm (mid-humeral area), right or left side. At the Follow-Up Visits 2, 3, 4 5, 6, 7 and 8 (Day 8, 15, 30, 60, 90, 180 or 270) participants will return to the study site for evaluation and grading of the implant sites by the Investigator per protocol. Participants will return for their Procedure Visit 1 and 2 (@ two of the randomly assigned time points; Day 30, 90, 180, 270 or 360). Each participant will have two procedure visits to remove their two implants by the investigator. Thirty (30) days after the second Procedure Visit, participants will return for post excision evaluation of the test sites. The total duration of the trial is 15 months.
Intervention code [1] 2395 0
Other interventions
Comparator / control treatment
None: This is s single group trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3659 0
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.
Timepoint [1] 3659 0
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
will be placed in the right or left proximal arm per protocol. All participants
enrolled in the study will be randomly assigned to two time points for biopsy
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
biopsy evaluation
Secondary outcome [1] 6183 0
Nil
Timepoint [1] 6183 0
Nil

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/08/2008
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
29/08/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2911 0
Commercial sector/Industry
Name [1] 2911 0
AESTHETIC SCIENCES CORPORATION INC
Country [1] 2911 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cosmetrend Pty Ltd
Address
6 King William Street,
GREENWICH 2065
Country
Australia
Secondary sponsor category [1] 2628 0
None
Name [1] 2628 0
Address [1] 2628 0
Country [1] 2628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4851 0
Bellberry Limited
Ethics committee address [1] 4851 0
Anzac Highway, Ashford, South Australia
Ethics committee country [1] 4851 0
Date submitted for ethics approval [1] 4851 0
03/01/2008
Approval date [1] 4851 0
01/05/2008
Ethics approval number [1] 4851 0
A21/08

Summary
Brief summary
2 RATIONALE
Currently, although there are a wide variety of surgical mesh products and soft
tissue implants commercially available, the ideal implant material has not yet
been found. These types of products have been used for a wide variety of
medical uses including but not limited to correction of wrinkles or other cosmetic
enhancements, scars and bulking of tissue to treat incontinence.
Synthetic
polymer based technology offers the potential of a longer lasting more durable
soft tissue implant.
This pilot study is
directed toward establishing the suitability of a implant material with Family C
microspheres suspended in a hyaluronic acid gel matrix (Family C Matrix) as a possible soft tissue implant in man.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28258 0
Mr na
Address 28258 0
na
Country 28258 0
Australia
Phone 28258 0
na
Fax 28258 0
Email 28258 0
na
Contact person for public queries
Name 11415 0
Mr Brenley MILSOM
Address 11415 0
5 Yatama Place
Currumbin Waters QLD 4223
Country 11415 0
Australia
Phone 11415 0
07055224880
Fax 11415 0
07055224128
Email 11415 0
[email protected]
Contact person for scientific queries
Name 2343 0
Mr Dr Darrell Perkins
Address 2343 0
14 Kensington Street
Kogarah NSW 2217
Country 2343 0
Australia
Phone 2343 0
02 95870871
Fax 2343 0
02095258400
Email 2343 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.