Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Endymion Medical Ltd
ClinicalTrials.gov Identifier:
NCT01029301
First received: December 8, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Skin Aging
Skin Wrinkling
Device: Device: EndyMed Pro System for Skin Tightening

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System

Resource links provided by NLM:


Further study details as provided by Endymion Medical Ltd:

Primary Outcome Measures:
  • 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). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy endpoint of using the EndyMed Pro System for skin tightening will be established by level of skin tightness improvement. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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);


  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029301

Sponsors and Collaborators
Endymion Medical Ltd
Investigators
Study Director: Varda Godfried, Dr. EndyMed Medical Ltd
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, EndyMed Medical Ltd
ClinicalTrials.gov Identifier: NCT01029301     History of Changes
Other Study ID Numbers: ED-IOP- 01
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Endymion Medical Ltd:
Skin aging
Skin Wrinkling

ClinicalTrials.gov processed this record on November 19, 2014