NCT01467778

Safety Study 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Elastagen Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Skin Conditions

Interventions

Type	Name	Description
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.
DEVICE	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

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2011-11-09
• Last updated: 2011-11-09

Locations

1 site across 1 country: Australia