Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pollogen
ClinicalTrials.gov Identifier:
NCT01283711
First received: January 25, 2011
Last updated: May 16, 2013
Last verified: November 2011
  Purpose

Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among female and male patients of all ages. Different technologies are presently available to rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL), however radiofrequency has emerged as the most effective and versatile modality for the broadest range of body and facial treatments, including non-invasive wrinkle treatment.

The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.

The apollo™ system is intended for use in dermatologic and general surgical procedures for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides treatments.


Condition Intervention
Facelift
Device: apollo device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides

Further study details as provided by Pollogen:

Primary Outcome Measures:
  • To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    The safety of using the apollo™ system for wrinkles and rhytides treatment will be established by physician's assessment/observation of adverse events.


Secondary Outcome Measures:
  • • To evaluate the efficacy of the apollo™ system for wrinkles and rhytides treatment. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Efficacy of using the apollo™ system for wrinkles and rhytides treatment will be established by level of wrinkle reduction.


Enrollment: 37
Study Start Date: March 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: apollo Device: apollo device
RF treatments for wrinkles and rhytides reduction

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject read, understood and signed the Consent Form
  • Healthy female/male aged 35 65 years,
  • Fitzpatrick wrinkle classification score 4 and above
  • Subject is capable of reading, understanding and following instructions of the procedure to be applied.
  • Subject is able and willing to comply with the treatment and follow-up schedule.

Exclusion Criteria:

  • Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
  • Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
  • Subject has current or history of cancer, especially skin cancer or premalignant moles or is undergoing any form of treatment for active cancer.
  • Subject has severe concurrent conditions such as epilepsy, lupus or cardiac disorders.
  • Subject has poorly controlled endocrine disorders such as diabetes.
  • Subject is female who is pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
  • Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
  • Subject has a condition that could be negatively affected by heat, including any history of diseases stimulated by heat, such as recurrent Herpes Simplex (in the treatment area).
  • Subject has diminished or exaggerated perception of temperature changes.
  • Subject has significant concurrent skin conditions affecting areas to be treated such as sores, hemorrhages or risk of hemorrhages, septic conditions, psoriasis, eczema and rash as well as very dry and fragile skin.
  • Subject has history of collagen disorders, keloid formation and abnormal wound healing.
  • Subject has had previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans on such treatment during the course of the study, or before complete healing has occurred.
  • Subject has had Botox injections in the treatment area within 6 months prior to initial treatment
  • Subject has had natural fillers within 9 months prior to initial treatment
  • Subject has synthetic fillers or gold/plastic threads in the treatment area.
  • Subject takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing such as prolonged steroid regime, tetracyclines, or St. John's Wort for the last 3 months.
  • Subject has used oral isotretinoin (Accutane or Roaccutan) within 6 months prior to study enrollment or plans use during the course of the study.
  • Subject has history of bleeding coagulopathies or use of anticoagulants.
  • Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
  • Concurrent participation in any other study.
  • Subject has mental disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283711

Locations
United States, Florida
Steven D. Shapiro MD
Palm Beach Gardens, Florida, United States, 33410
Israel
Kaplan Medical center
Rehovot, Israel, 76610
Sponsors and Collaborators
Pollogen
Investigators
Study Director: Mira Barki, Dr. Pollogen
  More Information

No publications provided

Responsible Party: Pollogen
ClinicalTrials.gov Identifier: NCT01283711     History of Changes
Other Study ID Numbers: PC210114_A
Study First Received: January 25, 2011
Last Updated: May 16, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Pollogen:
wrinkles reduction
rhytides reduction
RF treatment

ClinicalTrials.gov processed this record on April 23, 2014