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Trial details imported from ClinicalTrials.gov
Ethics application status
Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
A Phase 1B Study to Assess the Safety and Efficacy of Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
Universal Trial Number (UTN)
Intrinsic Aging of Skin
Description of intervention(s) / exposure
Treatment: Devices - Tropoelastin
Experimental: Restylane - Patients with an even subject identification number (SIN) (02, 04, 06, 08, 10, 12, 14, 16) will have ELAPR to the right arm and the control to the left, where patients with an odd subject identification number (01, 03, 05, 07, 09, 11, 13, 15) will have the ELAPR to the left arm and the control to the right.
Patients will receive either device ELAPR002c or ELAPR002e. This will alternate to minimise bias between the right and left arms.
The first group of eight patients (01 - 08) will have their biopsy performed at day 169. The second group of eight patients (09 - 16) will have their biopsy at day 85.
Treatment: Devices: Tropoelastin
Multiple intradermal implants comprising of three treatments, 3 weeks apart, each consisting of 16 injections in total, each 10mm apart in a grid formation over a 3cm x 3cm area of the mid to deep dermis of the medial aspect of the upper arm. Each injection will consist of 20-30ul of product delivered using a 30Gx¼" needle. Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. The treatment will be administered on Day 1, 22 and 43.
Intervention code 
Comparator / control treatment
Primary outcome 
Assess the persistence and tissue compatibility with histopathology. - A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects on Day 169, and from Cohort B subjects on Day 85.
Secondary outcome 
Assess the acute and chronic safety of ELAPR. - Biopsy at day 85 or day 169 depending on randomization
Key inclusion criteria
- Age 35 to 50 years
- Male or Female
- Good general health status
- Able to give informed consent
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 anti-inflammatory drugs or other
- History of keloid formation
- Systemic corticosteroids within last 12 weeks
- Diabetes or other metabolic disorders that may interfere with the subject's response
to treatment in the opinion of the investigator
- Any serious medical condition which in the opinion of the investigator would have a
strong possibility of requiring systemic corticosteroid medication
- Previously received Tropoelastin
- A history of anaphylaxis or allergic reactions including any known hypersensitivity to
Hyaluronic acid or lidocaine
- Sensitivity to Restylane® Vital light or Restylane products
- Use of any other investigational product on the intended implant site in the previous
- Sensitivity to topical local anaesthetic cream (EMLA®) or have the following
conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia,
Glucose-6-phosphate dehydrogenase deficiency or "Mollusca Contagiosa"
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
This is an early phase study comparing two fixed dose of the study compound ELAPR and a
Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of
the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each
treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a
3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each
injection will consist of 20-30ul of product delivered using a 30Gx¼" needle.
Trial related presentations / publications
Carlos China, MBBS
Woolcock Institute Medical Research