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Trial registered on ANZCTR


Registration number
ACTRN12611001205921
Ethics application status
Approved
Date submitted
7/11/2011
Date registered
23/11/2011
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 1B study to assess the safety and efficacy of two formulations of ELAPR (Tropoelastin) compared to Restylane (registered trademark) 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 (registered trademark) Vital light following repeat implants in the upper arm dermis in healthy volunteers.
Secondary ID [1] 273345 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
ELAPR P1B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy human volunteers 279111 0
Skin 279114 0
Condition category
Condition code
Skin 279305 279305 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple intradermal implants comprising of three treatments, 3 weeks apart, each consisting of 21 injections in total, each 5mm 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 delivered by the treating doctor will consist of approximately 20ul of product delivered using a 30Gx1/4 inch needle. Each subject will receive ELAPR then Restylane (Registered Trademark) Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. The concurrent treatment will be administered every three weeks on Day 1, 22 and 43.
Intervention code [1] 283686 0
Treatment: Devices
Comparator / control treatment
Restylane (Registered Trademark) Vital Light
Control group
Active

Outcomes
Primary outcome [1] 279914 0
To assess the persistence and tissue compatibility of ELAPR following dermal implantation for up to 26 weeks. A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects (including replacements) on Day 169, and from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the needle point tattoo at the centre of the implant site. The biopsy site will be closed with a single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days later.
Timepoint [1] 279914 0
26 weeks
Secondary outcome [1] 294767 0
To assess the acute and chronic safety of ELAPR. Safety evaluations will consist of monitoring and recording of all spontaneously reported and observed adverse reactions to the study device, general physical examination, clinical laboratory safety testing.
Timepoint [1] 294767 0
26 weeks
Secondary outcome [2] 294768 0
To assess the effects of ELAPR on skin elastin content, At each visit, subjects will be asked questions related to the status of implants, skin site texture and elasticity, skin reactions and any activities undertaken which may impact on the implant. Measurements of skin elasticity and skin thickness will be made using a Dermal Torque Meter (DTM) and skin calipers, respectively.
Timepoint [2] 294768 0
26 weeks
Secondary outcome [3] 294769 0
To assess the effects of ELAPR on skin elasticity and skin thickness.The physical presence of the implants will be assessed by the investigator at each visit by palpation.
Timepoint [3] 294769 0
26 weeks
Secondary outcome [4] 294770 0
To assess the effects of ELAPR on subjective comfort and feel of the implant using Visual Analogue Scales at before and one hour post treatment and at each follow-up visit.
Timepoint [4] 294770 0
26 weeks

Eligibility
Key inclusion criteria
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 (Registered Trademark) 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(Registered Trademark)) 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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following a screening period of up to 28 days, subjects who meet the entry requirements will be enrolled to one of two Cohorts, Cohort A or B and randomly assigned to receive treatment with one of two ELAPR formulations plus the control. The patients will be notified at the end of the study which treatment they were allocated to. The PI and study staff are Allocation is not concealed to the PI and study staff. All subjects will receive three treatments, 3 weeks apart.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once the patient has the subject identification recorded on the enrollment log, they will be allocated into the treatment arms. Treatment allocation was devised by using a randomisation table from a treatment statistic book
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.
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 as described to minimize bias between the right and left arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment postcode(s) [1] 4749 0
2015

Funding & Sponsors
Funding source category [1] 284169 0
Commercial sector/Industry
Name [1] 284169 0
Elastagen Pty Ltd
Address [1] 284169 0
4 Cornwallis Street
Eveleigh 2015 NSW
Country [1] 284169 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Elastagen Pty Ltd
Address
4 Cornwallis Street
Eveleigh 2015 NSW
Country
Australia
Secondary sponsor category [1] 269124 0
None
Name [1] 269124 0
Address [1] 269124 0
Country [1] 269124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286130 0
Bellberry Limited
Ethics committee address [1] 286130 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 286130 0
Australia
Date submitted for ethics approval [1] 286130 0
16/08/2011
Approval date [1] 286130 0
09/09/2011
Ethics approval number [1] 286130 0
2011-06-332

Summary
Brief summary
This is a phase 1 study utilizing two fixed dose formulations of ELAPR and a control, by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis. Healthy subjects will be recruited to the study. Following a screening period of up to 28 days, subjects who meet the entry requirements will be enrolled to one of two Cohorts, Cohort A or B and randomly assigned to receive treatment with one of two ELAPR formulations plus the control. All subjects will receive three treatments, 3 weeks apart.Subjects will attend the Woolcock Institute of Medical Research, Clinical Research Operations (WIMR) for all procedures. On Day 1, 22 and 43 all subjects will have the intradermal injections at WIMR. Subjects will then have safety observations for 60 minutes. Photography of injected sites will be performed before and 60 minutes following intradermal injections. Subjects will return to the WIMR on Day 8, 29 and 50, for evaluation. Each treatment will consist of 21 injections in total, each 5mm 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 approximately 20ul of product delivered using a 30Gx1/4 inch needle. On Day 1, following the intradermal injections a needle point tattoo will be applied to the center of the implant site. The tattoo mark will assist in locating the implant sites and will be removed with the biopsy at Day 169 for cohort A and Day 85 for cohort B. Each subject will also receive Restylane (Registered Trademark) Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique.
A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects (including replacements) on Day 169, and from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the needle point tattoo at the centre of the implant site. The biopsy site will be closed with a single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days later.
At each visit, subjects will be asked questions related to the status of implants, skin site texture and elasticity, skin reactions and any activities undertaken which may impact on the implant. The physical presence of the implants will be assessed by the investigator at each visit by palpation. Measurements of skin elasticity and skin thickness will be made using a Dermal Torque Meter (DTM) and skin calipers, respectively.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33360 0
Address 33360 0
Country 33360 0
Phone 33360 0
Fax 33360 0
Email 33360 0
Contact person for public queries
Name 16607 0
Dr Robert Daniels
Address 16607 0
Elastagen Pty Ltd
4 Cornwallis Street
Eveleigh 2015 NSW
Country 16607 0
Australia
Phone 16607 0
+61 (2) 9209 4054
Fax 16607 0
+61 (2) 9310 7232
Email 16607 0
admin@elastagen.com
Contact person for scientific queries
Name 7535 0
Dr Robert Daniels
Address 7535 0
Elastagen Pty Ltd
4 Cornwallis Street
Eveleigh 2015 NSW
Country 7535 0
Australia
Phone 7535 0
+61 (2) 9209 4054
Fax 7535 0
+61 (2) 9310 7232
Email 7535 0
admin@elastagen.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary