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

NCT ID: NCT01029301

Last Updated: 2009-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-11-30

Brief 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

Keywords

Skin aging; Skin Wrinkling

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Endymed study group

Group Type: EXPERIMENTAL

Device: EndyMed Pro System for Skin Tightening

Intervention Type: DEVICE

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);

Interventions

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);

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endymion Medical Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

EndyMed Medical Ltd

Principal Investigators

Varda Godfried, Dr.

Role: STUDY_DIRECTOR

EndyMed Medical Ltd

Other Identifiers

ED-IOP- 01

Identifier Type: -

Identifier Source: org_study_id