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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Skin Wrinkling
• Intervention / Treatment: Device: Device: EndyMed Pro System for Skin Tightening

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and females age 30 and up
• Subjects with Fitzpatrick 4 to 9 degrees of elastosis
• Subject able to comprehend and give informed consent for participation in this study
• Subject must commit to all treatments and follow-up visits
• Subject must sign the Informed Consent Form

Exclusion Criteria:

• Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
• Subjects with any implantable metal device in the treatment area
• Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months
• Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 6 months (in the treated area)
• Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treatment area at the period of the study
• Subjects who have any form of suspicious lesion on the treatment area
• Subjects with history of keloid formations or hypertrophic scarring
• Pregnant or lactating Subjects
• Subjects with Epilepsy or severe migraines
• Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
• Subjects with any Infection / abscess / pains in treatment target area
• Eczema or dermatitis
• Subjects who suffer from autoimmune disorders or diabetes
• Subjects using blood thinning medications
• Subjects with clotting disorders
• Subjects on drugs or psychologically determined unsuitable for the study
• Subject is suffering extreme general weakness
• Subject objects to the study protocol
• Concurrent participation in any other clinical study
• Physician objection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Endymed study group	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);

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The safety of using the EndyMed Pro System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn).	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy endpoint of using the EndyMed Pro System for skin tightening will be established by level of skin tightness improvement.	3 months

Collaborators and Investigators

• Sponsor: Endymion Medical Ltd
• Investigators: Study Director: Varda Godfried, Dr., EndyMed Medical Ltd

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 9, 2009
• Last Update Submitted That Met QC Criteria: December 8, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Skin aging; Skin Wrinkling
• Other Study ID Numbers: ED-IOP- 01