Clinical trial NCT01466413: Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intrinsic Aging of Skin
Keywords: Intrinsic Aging of Skin
Lead sponsor: Elastagen Pty Ltd
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 16
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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"

Primary outcomes:
measure: Assess the persistence and tissue compatibility with histopathology.
timeFrame: 26 weeks
Secondary outcomes:
measure: Assess the acute and chronic safety of ELAPR.
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Glebe
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Woolcock Institute Medical Research
name: Carlos China, MBBS
role: PRINCIPAL_INVESTIGATOR
References: