Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis

Intrinsic Aging of Skin Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466413
• Other study ID #: ELAPR P1B
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2011
• Last updated: October 11, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Elastagen Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Each subject will also receive Restylane® 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 35 to 50 years

• Male or Female

• Good general health status

• Able to give informed consent

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intrinsic Aging of Skin

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Woolcock Institute of Medical Research	Glebe	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Elastagen Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	26 weeks	No
Secondary	Assess the acute and chronic safety of ELAPR.	Biopsy at day 85 or day 169 depending on randomization	26 weeks	Yes