Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming weeks in order to comply with the updated WHO Trial Registration Data Set.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01467778




Trial ID
NCT01467778
Ethics application status
Date submitted
22/03/2011
Date registered
7/11/2011
Date last updated
7/11/2011

Titles & IDs
Public title
Safety Study 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] 0 0
ELAPR-P1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Conditions 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ELAPR
Treatment: Devices - ELAPR

Active Comparator: ELAPR001 - Tropoelastin 0.1ml SC implant

Active Comparator: ELAPR002 - Tropoelastin 0.1ml SC implant

Active Comparator: ELAPR003 - Tropoelastin 0.1ml SC implant

Placebo Comparator: Saline - Normal Saline 0.9%


Treatment: Devices: ELAPR
ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.

Treatment: Devices: ELAPR
Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability measured by the amount of adverse events and serious adverse events - To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects by reported adverse events and serious adverse events
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Persistence - To determine implant persistence by histopathology and clinical observation
Timepoint [1] 0 0
6 weeks

Eligibility
Key inclusion criteria
- Good general health status
Minimum age
18 Years
Maximum age
70 Years
Gender
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
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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 0 0
2037 - Glebe

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elastagen Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase I study to assess the safety of three formulations of the dermal implant
ELAPR.
Trial website
https://clinicaltrials.gov/show/NCT01467778
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carlos China, MBBS
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries