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Completed

NCT Number: NCT01466413

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

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.

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Key information

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Woolcock Institute of Medical Research

Glebe, New South Wales, 2050, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Tropoelastin

Device

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.

Other names: Restylane Vital Light

Primary outcomes

  1. Assess the persistence and tissue compatibility with histopathology.

    Time frame: 26 weeks

    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 outcomes

  1. Assess the acute and chronic safety of ELAPR.

    Time frame: 26 weeks

    Biopsy at day 85 or day 169 depending on randomization

Sponsors and collaborators

Lead sponsor

Elastagen Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2011
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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