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Trial registered on ANZCTR


Registration number
ACTRN12610000871044
Ethics application status
Approved
Date submitted
13/10/2010
Date registered
18/10/2010
Date last updated
11/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I study to assess the safety of three formulations of the dermal implant ELAPR
Scientific title
A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.
Secondary ID [1] 252803 0
n/a
Universal Trial Number (UTN)
U1111-1117-3322
Trial acronym
ELAPR-P1A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects are to be used in the study to assess the safety of the dermal implant. 258307 0
The dermal implant ELAPR is being developed to treat the symptoms of skin aging or damage including wrinkles, scarring and photoaging. 258435 0
Condition category
Condition code
Skin 258500 258500 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three formulations of the dermal implant ELAPR are to be evaluated in the study. All three formulations are based on the protein tropoelastin which is the building block of elastin - a major structural component of the skin providing it with its ability to stretch and recoil. The three formulations differ in the presentation of the tropoelastin: formulation 1 is the tropoelastin alone; formulation 2 contains a combination of tropoelastin and hyaluronic acid; formulation 3 contains tropoelastin cross-linked with glutaraldehyde.

Each of the 12 participants will receive a 0.1ml implant of each of the three formulations of ELAPR and one of a saline control (total four implants) in the medial aspect of the upper arm. All four implant sites will be subject to a single biopsy at three separate time points - four participants will have their implants biopsied at Day 8, four at Day 15 and four at Day 29.
Intervention code [1] 257327 0
Treatment: Devices
Comparator / control treatment
Saline
Control group
Active

Outcomes
Primary outcome [1] 259335 0
To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects. This will be assessed by clinical observation of the implant sites throughout the duration of the study; haematology and blood biochemistry analysis; and, histopathology and immunohistochemistry of a tissue biopsy sample from each implant site to evaluate implant persistance and identify any cellular responses to the implant material.
Timepoint [1] 259335 0
- Clinical evaluation of the implant sites will occur for 60 minutes after implantation and on Days 4, 8, 15, 29 and 43.
- Blood haematology and biochemical analysis will occur during screening and at Day 1, 4 and 29.
- Biopsies for histopathology will be taken on Day 8, 15 and 29 (four participants each).
Secondary outcome [1] 265785 0
To determine implant persistence by histopathology and clinical observation
Timepoint [1] 265785 0
- Clinical evaluation of the implant sites will occur for 60 minutes after implantation and on Days 4, 8, 15, 29 and 43.
- Biopsies for histopathology will be taken on Day 8, 15 and 29 (four participants each).

Eligibility
Key inclusion criteria
Age

Good general health status
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant abnormalities of haematology or
biochemistry testing

Bleeding diathesis, anticoagulant drugs,
thrombocytopenia or clinically significant prolonged
APTT or PT

Chronic use of aspirin, other non-steroidal antiinflammatory
drugs or other anti-platelet agents

History of keloid formation

Systemic corticosteroids within last 12 weeks

Diabetes or metabolic disorders

Any serious medical condition which in the opinion of
the investigator would have a strong possibility of
requiring systemic corticosteroid medication

Pregnancy/lactation

A history of anaphylaxis or allergic reactions including
any known hypersensitivity to Hyaluronic acid or
lidocaine

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/11/2010
Actual
22/11/2010
Date of last participant enrolment
Anticipated
Actual
21/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257828 0
Commercial sector/Industry
Name [1] 257828 0
Elastagen Pty Ltd
Country [1] 257828 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Elastagen Pty Ltd
Address
Australian Technology Park
Suite 145, National Innovation Centre
Eveleigh, Sydney
NSW 2015
Country
Australia
Secondary sponsor category [1] 257030 0
None
Name [1] 257030 0
Address [1] 257030 0
Country [1] 257030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259859 0
Belberry Ltd
Ethics committee address [1] 259859 0
Bellberry Limited
229 Greenhill Road
Dulwich SA 5065
Ethics committee country [1] 259859 0
Australia
Date submitted for ethics approval [1] 259859 0
05/10/2010
Approval date [1] 259859 0
Ethics approval number [1] 259859 0
2010-09-484

Summary
Brief summary
Elastin is a major structural component of the skin which enables the skin to stretch and recoil. The loss or damage of elastin in the skin results in a range of skin abnormalities including, the symptoms of skin aging such as wrinkles, scars and the signs of sun damage. ELAPR is a dermal implant which is made from a synthetic form of human elastin and is being developed as a product which may be injected superficially into the skin using very fine needles to treat skin abnormalities associated with the loss of elastin. The synthetic human elastin which is the basis of the ELAPR dermal implant is a completely new product and the purpose of the current clinical trial is to evaluate the safety of the product in humans. The trial will involve the implantation of a small volume of the product in the skin of the upper arm of study participants. The implant will remain in the skin for a period of up to 29 days. The implant will then be removed by a needle biopsy to allow studies to be carried out on the tissue surrounding the implant to see how the body responded to the presence of the implant in the skin. The results of this study will provide a good understanding of how well the body tolerates this new synthetic human elastin material. If the synthetic elastin is well tolerated by the body then further studies will be undertaken to study its use in the treatment of skin abnormalities resulting from aging, scarring and sun damage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31725 0
Dr Carlos China
Address 31725 0
Clinical Research Operations Group
Woolcock Institute of Medical Research
431 Glebe Point Rd,
Glebe, NSW 2037 Australia
Country 31725 0
Australia
Phone 31725 0
+61 2 9209 4054
Fax 31725 0
Email 31725 0
[email protected]
Contact person for public queries
Name 14972 0
Robert Daniels
Address 14972 0
Australian Technology Park
Suite 145, National Innovation Centre
Eveleigh, Sydney
NSW 2015
Country 14972 0
Australia
Phone 14972 0
+61 2 9209 4054
Fax 14972 0
Email 14972 0
[email protected]
Contact person for scientific queries
Name 5900 0
Robert Daniels
Address 5900 0
Australian Technology Park
Suite 145, National Innovation Centre
Eveleigh, Sydney
NSW 2015
Country 5900 0
Australia
Phone 5900 0
+61 2 9209 4054
Fax 5900 0
Email 5900 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
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Documents added automatically
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