Safety Study of Three Formulations of the Dermal Implant ELAPR

Phase 1CompletedNCT01467778

Elastagen Pty Ltd14 enrolled

Overview

This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Skin Conditions

Interventions

ELAPRDEVICE

ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.

ELAPRDEVICE

Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Good general health status 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 antiinflammatory drugs or other anti-platelet agents * History of keloid formation * Systemic corticosteroids within last 12 weeks * Diabetes or metabolic disorders * Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication * Pregnancy/lactation * A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine

Locations (1)

Woolcock Institute of Medical Research

Glebe, New South Wales, Australia

Outcomes

Primary Outcomes

Safety and tolerability measured by the amount of adverse events and serious adverse events

To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects by reported adverse events and serious adverse events

Time frame: 6 weeks

Secondary Outcomes

Persistence

To determine implant persistence by histopathology and clinical observation

Time frame: 6 weeks

Data from ClinicalTrials.gov

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