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CompletedNCT00945685Updated Jul 24, 2009

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

An interventional study of Endymion Imagine™ System for Skin Tightening in Skin Aging and Skin Wrinkling, sponsored by Endymion Medical Ltd. Completed at 1 site in Israel. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-24.

Sponsored by Endymion Medical Ltd · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
30 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Aging
  • Skin Wrinkling

Keywords

  • Skin Aging
  • Skin Wrinkling
03

In context

Lead sponsor

Endymion Medical Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Endymion study group

    Device: Endymion Imagine™ System for Skin Tightening

Interventions

  • DeviceEndymion Imagine™ 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);

06

What researchers measure

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).

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

07

Study locations

1 site
  • Elman Clinique
    Rishon LeZiyyon, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00945685
Lead sponsor
Endymion Medical Ltd
First posted
Jul 24, 2009
Start date
Jul 2008
Primary completion
Jun 2009
Completion
Jul 2009
Last update
Jul 24, 2009

Study contacts

Varda Godfried, Dr.
study director · Endymion Medical Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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