NCT01029301

Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System for Skin Wrinkle Treatment on Body Areas

Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System

• 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). EndyMed has developed the EndyMed Pro 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 EndyMed Pro system.

Conditions

• Skin Aging
• Skin Wrinkling

Interventions

Type	Name	Description
DEVICE	Device: EndyMed Pro 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: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-12-09
• Last updated: 2009-12-09