Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upp… (NCT01466413) | Clinical Trial Compass
CompletedPhase 1
Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
Australia16 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range35 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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"
What they're measuring
1
Assess the persistence and tissue compatibility with histopathology.