Facial WrinklesNCT01858415
Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles
A study testing TriPollar in people with Facial Wrinkles, run by Pollogen at 2 sites in United States.
Trial summary
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- TriPollar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Dec 2013
- 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, discussed and signed the Consent Form,
- Healthy female/male aged 35 65 years,
- Has facial wrinkles,
- Capable of reading, understanding and following instructions of the procedure to be applied,
- Able and willing to comply with the treatment and follow-up schedule.
Who cannot join
- Listed in approved protocol, and ICF
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ronald L Moy, Inc.
Beverly Hills, California, 90210
Reaserch Across America
Plano, Texas, 75093
About this study
Official title: Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.
Read the detailed description
The TriPollar 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.
- Conditions
- Facial Wrinkles
- Being tested
- TriPollar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriPollarDevice
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Device: TriPollar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TriPollar
Safety will be established by physician's assessment/observation of adverse events.
Measured: 6 months
Efficacy of TriPollar
Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pollogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mira Barki, PhD, Study director, Pollogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858415
- Sponsor's protocol ID
- PC210118_S, rev. 01
- Status last verified
- Aug 2013
- First submitted
- 21 Apr 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides
- ClinicalTrials.gov ID
- NCT01858415
- Acronym / sponsor ID
- PC210118_S, rev. 01
- Conditions
- Facial Wrinkles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PollogenIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 21 May 2013 (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.
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.
Detailed description
The TriPollar 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: TriPollar |
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, discussed and signed the Consent Form,
- Healthy female/male aged 35 65 years,
- Has facial wrinkles,
- Capable of reading, understanding and following instructions of the procedure to be applied,
- Able and willing to comply with the treatment and follow-up schedule.
Key exclusion criteria (1 listed)
- Listed in approved protocol, and ICF
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 |
|---|---|---|
| TriPollar | Device | Single arm |
Primary outcome
Safety of TriPollar
Time frame: 6 months
Safety will be established by physician's assessment/observation of adverse events.
Efficacy of TriPollar
Time frame: 6 months
Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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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, PhD study director
Pollogen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriPollar in people with Facial Wrinkles, run by Pollogen at 2 sites in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Aug 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. 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?
Results are not available in the source record.
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?
Safety of TriPollar (time frame: 6 months). The study lists 2 primary outcomes in all. 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 13 Aug 2013.