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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
- Good general health status
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Elastagen Pty Ltd

Ethics approval
Ethics application status

Brief summary
This is a Phase I study to assess the safety of three formulations of the dermal implant
Trial website
Trial related presentations / publications
Public notes

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

Summary results
Other publications