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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01466413




Registration number
NCT01466413
Ethics application status
Date submitted
18/09/2011
Date registered
8/11/2011
Date last updated
15/10/2012

Titles & IDs
Public title
Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
Scientific title
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
Secondary ID [1] 0 0
ELAPR P1B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intrinsic Aging of Skin 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
26 weeks
Secondary outcome [1] 0 0
Assess the acute and chronic safety of ELAPR. - Biopsy at day 85 or day 169 depending on randomization
Timepoint [1] 0 0
26 weeks

Eligibility
Key inclusion criteria
- Age 35 to 50 years

- Male or Female

- Good general health status

- Able to give informed consent
Minimum age
35 Years
Maximum age
50 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 anti-inflammatory drugs or other
anti-platelet agents

- 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

- Pregnancy/lactation

- 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
12 months.

- 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"

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
2050 - 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 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 website
https://clinicaltrials.gov/show/NCT01466413
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carlos China, MBBS
Address 0 0
Woolcock Institute 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