FaceliftNCT01283711
Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides
A study testing apollo device in people with Facelift, run by Pollogen at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facelift
- What is being tested?
- apollo device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Steven D. Shapiro MD
Palm Beach Gardens, Florida, 33410
About this study
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.
- Conditions
- Facelift
- Being tested
- apollo device
- Keywords
- wrinkles reduction, rhytides reduction, RF treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apollo deviceDevice
RF treatments for wrinkles and rhytides reduction
| Study group | Role | What they receive |
|---|---|---|
| apollo | Experimental | Not described Receives: Device: apollo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment.
The safety of using the apollo™ system for wrinkles and rhytides treatment will be established by physician's assessment/observation of adverse events.
Measured: 5 months
Secondary outcomes (1)
• To evaluate the efficacy of the apollo™ system for wrinkles and rhytides treatment.
Efficacy of using the apollo™ system for wrinkles and rhytides treatment will be established by level of wrinkle reduction.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FaceliftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pollogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mira Barki, Dr., Study director, Pollogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283711
- Sponsor's protocol ID
- PC210114_A
- Status last verified
- Nov 2011
- First submitted
- 25 Jan 2011
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides
- ClinicalTrials.gov ID
- NCT01283711
- Acronym / sponsor ID
- PC210114_A
- Conditions
- Facelift
- Keywords
- wrinkles reduction, rhytides reduction, RF treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PollogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apollo | Experimental | Device: apollo device |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apollo deviceRF treatments for wrinkles and rhytides reduction | Device | apollo |
Primary outcome
To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment.
Time frame: 5 months
The safety of using the apollo™ system for wrinkles and rhytides treatment will be established by physician's assessment/observation of adverse events.
1 secondary outcome
• To evaluate the efficacy of the apollo™ system for wrinkles and rhytides treatment.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
Related trials for Facelift
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Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy
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Ultrasound-Assessed Facial Macrofat Retention After Facelift
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PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mira Barki, Dr. study director
Pollogen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apollo device in people with Facelift, run by Pollogen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.