Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000223437
Ethics application status
Approved
Date submitted
26/04/2007
Date registered
27/04/2007
Date last updated
20/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A SINGLE CENTER OPEN-LABEL PILOT STUDY TO EVALUATE THE TOLERABILITY AND SAFETY OF A SYNTHETIC SOFT TISSUE IMPLANT MATERIAL IN THE SKIN OF NORMAL VOLUNTEERS
Scientific title
A single centre open-label pilot study to evaluate the tolerability and safety of the Family C synthetic thermoplastic block copolymer implant as a clinically acceptable dermal filler material in healthy volunteers.
Secondary ID [1] 287952 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tolerability and safety of a new synthetic soft tissue implant material for soft tissue augmentation in healthy volunteers. 1754 0
Condition category
Condition code
Surgery 1845 1845 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will receive two (diameter - 4.4 mm, thickness ~1 to 2 mm) Test Article implants, placed at the mid-to-deep dermal layer and/or superficial fat junction of their skin. The implant sites will be selected by the investigator within the anatomic region of the torso (superior pelvic rim to the apex of the shoulders) of each participant. The skin implant material will be placed by making a small single incision, up to 1.5 cm in length to the level of the mid-to-deep dermis or superficial fat junction, as appropriate. The implant will then be placed into the incision pocket and sutured closed. The implants will remain in place for 90 days with follow up visits at days 7, 14, 30, 60 for evaluation and grading of site per protocol. At day 90 the implants will be excised. All specimens will be submitted for histologic examination. A final visit will occur 30 days post excision for evaluation of the test sites.
Intervention code [1] 1723 0
Treatment: Devices
Intervention code [2] 2616 0
Other interventions
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2584 0
Safety Endpoints:
The number and percentage of participants who develop a positive response to the implant(s).
Timepoint [1] 2584 0
Participants are intructed to observe the test sites daily for any positive response as per protocol. Participants return for evaluation and grading of the sites on days 7, 14, 30 & 60 and then on day 90 following grading of the implant site, for excision of the implants. A final follow up visit occurs on day 120 for post excision evaluation of the implant sites.
Primary outcome [2] 2585 0
Safety Endpoints: Histologic findings and adverse events will be summarized.
Timepoint [2] 2585 0
Participants are intructed to observe the test sites daily for any positive response as per protocol. Participants return for evaluation and grading of the sites on days 7, 14, 30 & 60 and then on day 90 following grading of the implant site, for excision of the implants. A final follow up visit occurs on day 120 for post excision evaluation of the implant sites.
Secondary outcome [1] 4444 0
NIL
Timepoint [1] 4444 0
NIL

Eligibility
Key inclusion criteria
1. In generally good health2. Participants willing and able to comply with the requirements of the study3. Participants willing and able to comply with the follow-up requirements4. Participants willing and able to give informed consent5. Females must be post-menopausal, surgically sterile or willing to use a medically acceptable form of birth control during the study. Males must be 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 period2. 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 corticosteroids is acceptable.3. Participants who were or are currently being treated with any topical Over The Counter (OTC) drug or prescription therapy on their torso 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. auto-immune 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. Participant is currently enrolled in an investigational drug or device study. 9. Participant has 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
Single group
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
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1993 0
Commercial sector/Industry
Name [1] 1993 0
AESTHETIC SCIENCES CORPORATION
Country [1] 1993 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
COSMETREND PTY LTD
Address
Po Box 5056,
Greenwich NSW 2065
Country
Australia
Secondary sponsor category [1] 1804 0
None
Name [1] 1804 0
NIL
Address [1] 1804 0
Country [1] 1804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3700 0
BellBerry Limited
Ethics committee address [1] 3700 0
Ethics committee country [1] 3700 0
Australia
Date submitted for ethics approval [1] 3700 0
Approval date [1] 3700 0
12/06/2007
Ethics approval number [1] 3700 0

Summary
Brief summary
The primary purpose of this pilot study is to assess the clinical tolerability and safety of a new synthetic soft tissue implant material in the skin of healthy volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27826 0
Mr na
Address 27826 0
na
Country 27826 0
Australia
Phone 27826 0
na
Fax 27826 0
Email 27826 0
na
Contact person for public queries
Name 10912 0
Ms Brenley Milsom
Address 10912 0
ADVANTAGE Medical Products Consulting Pty Ltd
5 Yatama Place (PO Box 339)
Currumbin Waters QLD 4223
Country 10912 0
Australia
Phone 10912 0
+61 7 55224880
Fax 10912 0
+61 7 55224128
Email 10912 0
[email protected]
Contact person for scientific queries
Name 1840 0
Mr Dr Darrell Perkins
Address 1840 0
AESTHETIC DAY SURGERY
14 Kensington Street
Kogarah NSW 2217
Country 1840 0
Australia
Phone 1840 0
+61 2 95870871
Fax 1840 0
+61 2 95258400
Email 1840 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.