Safety Study of Three Formulations of the Dermal Implant ELAPR

Skin Conditions Clinical Trial

Official title:

A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467778
• Other study ID #: ELAPR-P1
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2011
• Last updated: November 7, 2011
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• 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 a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Skin Conditions
• Skin Diseases

Intervention

Device:
• ELAPR
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.
• ELAPR
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

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	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	6 weeks	Yes
Secondary	Persistence	To determine implant persistence by histopathology and clinical observation	6 weeks	Yes