NCT00945685

Evaluation of Safety and Efficacy of Using Imagine™ Computerized Radiofrequency System for Skin Tightening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Endymion Medical Ltd · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen modification, skin laxity and cellulite (dermis and hypodermis). EndyMion has developed the Imagine™ system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the Imagine™ system.

Conditions

• Skin Aging
• Skin Wrinkling

Interventions

Type	Name	Description
DEVICE	Endymion Imagine™ System for Skin Tightening	Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed): * Pulse energy (J); * RF frequency (1MHz); * Pulse duration (30 sec); * Treatment hand piece (skin tightening);

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2009-07-24
• Last updated: 2009-07-24

Locations

1 site across 1 country: Israel