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

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.

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Key information

Conditions

Skin Aging Skin Wrinkling

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elman Clinique

Rishon LeZiyyon, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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);

Primary outcomes

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).

Time frame: 3 months

Secondary outcomes

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

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Endymion Medical Ltd

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jul 24, 2009
Registry last updated: Jul 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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