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

NCT00945685 | Completed

• 1 other identifier: EN-IOP - 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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). 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

Keywords

Skin Aging; Skin Wrinkling

Outcome Measures

Primary Outcomes (1)

• The safety of using the Imagine™ 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 Outcomes (1)

• Efficacy endpoint of using the Imagine™ System for skin tightening will be established by level of skin tightness improvement.

  3 months

Study Arms (1)

Endymion study group

EXPERIMENTAL

Device: Endymion Imagine™ System for Skin Tightening

Interventions

Endymion Imagine™ System for Skin Tightening 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);

Endymion study group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endymion Medical Ltd: lead

Study Sites (1)

Elman Clinique

Rishon LeZiyyon, Israel

Location

Study Officials

• Varda Godfried, Dr.

  Endymion Medical Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 24, 2009

Record last verified: 2009-07

Locations

IL (1)