Safety and Efficacy of the EndyMed Pro System Using RF Micro-needles Fractional Skin Remodeling

NCT02368626 | Unknown DMC

• 1 other identifier: EM-FR-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The need for cosmetic facial enhancement procedures with minimal down time and low risk has led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers were developed, which remove the full skin surface in a controlled manner. However, the prolonged recovery and the significant risks prompted the development of fractional lasers which ablate the skin in a fractional manner, leaving untreated areas to improve healing process. In the past few years, fractional RF systems have been introduced that enable controlled skin resurfacing accompanied with dermal collagen remodeling. System using focused ultrasound , coagulating small volume of tissue in the dermis , have shown a lifting effect.8 Similar to these devices the EndyMed Pro™ System with RF Micro-Needles handpiece (INTENSIF) enables fractional skin coagulation with dermal heating for the reduction of wrinkles together with a lifting effect.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by Adverse events occurrence

  Adverse events occurrence

  5 months

Secondary Outcomes (1)

• To evaluate the efficacy of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by wrinkle appearance reduction

  5 months

Study Arms (1)

RF ablation treatment

EXPERIMENTAL

'EndyMed Pro™ RF Micro-Needles' - RF ablation treatments for wrinkle appearance reduction

Device: EndyMed Pro™ RF Micro-Needles

Interventions

EndyMed Pro™ RF Micro-Needles DEVICE

RF Micro-needles ablation treatments

RF ablation treatment

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy patients age 35-60 with facial condition as required by the treatment.
• Subjects with Fitzpatrick elasticity level of 4 and above
• Subject able to comprehend and sign informed consent for participation in this study.
• Subject must commit to all treatments and follow-up visits.
• Subjects must approve the use of their B\&A photos by the doctor and EndyMed

You may not qualify if:

• Subjects with implanted pacemakers, arrhythmias or any other electronic implanted device or 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 3 months.
• Subjects that have had any other invasive or noninvasive method of skin therapy hair removal, filers or Botox, performed in the past 3 months (in the treated area).
• Subjects who are scheduled or planned for any other invasive or noninvasive method of skin therapy in the treatment area at the period of the study.
• Subjects who have any form of suspicious lesion on the treatment area.
• Subjects with hypertrophic scarring, keloids, abnormal wound healing, as well as very dry and fragile skin.
• 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.
• History of any kind of cancer
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.

Sponsors & Collaborators

• EndyMed: lead

Study Officials

• Michael Gold, Dr

  Tennessee Clinical Research Center, Nashville, Tennessee, USA

  PRINCIPAL INVESTIGATOR

• Mark Taylor, Dr

  Gateway Aesthetic Institute and Laser Center, Salt Lake City, Utah, USA

  PRINCIPAL INVESTIGATOR

• Kenneth Rothaus, Dr

  Ageless Plastic Surgery, New York, NY, USA

  PRINCIPAL INVESTIGATOR

• Yohei Tanaka, Dr

  Clinica Tanaka Plastic and Reconstructive Surgery and Anti-aging Center, Tokyo, Japan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Levy, Dr

CONTACT

+972-52-2824966; hanna@qsitemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2015
• First Posted: February 23, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 23, 2015

Record last verified: 2015-02