Facial and Neck RhytidesNCT01299090
Prospective Pellevé™ Neck Wrinkle Study
A study testing Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator in people with Facial and Neck Rhytides, run by Ellman International at 1 site in United States.
Trial summary
Use of RF device to treat wrinkles of the neck Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial and Neck Rhytides
- What is being tested?
- Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-70 years of age
- Subjects with clinical evidence of neck wrinkles moderate to severe in severity as specified by a grade 4-9 on the Fitzpatrick Wrinkle Assessment Scale.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Willingness and ability to provide written photo consent and adherence to photography procedures(i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Who cannot join
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study.
- Subjects who have had prior exposure to any botulinum toxin for rhytids in the treatment area in the 6 months preceding study enrollment through the duration of the study.
- Subjects who have had a prior cosmetic procedure to improve rhytids in the treatment area (i.e.,rhytidectomy, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment)within 12 months or who have visible scars that may affect evaluation of response and/or quality of photography.
- Microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study.
- Active cut, wound, or infection on the skin.
Show all 21Show fewer
- Oral Isotretinon within the past 12 months.
- Active HSV-1.
- History of keloids or hypertrophic scarring.
- Existing or history of skin malignancy in the treatment area during the past 12 months.
- Existing or history of skin disease in the treatment area during the past 12 months.
- History of collagen or vascular disease.
- Subjects who have implantable pacemaker, automatic implantable defibrillator/ cadioversor (AICD), or any other implantable electric device.
- Subjects who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics.
- History of autoimmune disease.
- History of any disease that inhibits pain sensation.
- History of Diabetes I or II.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- Subjects who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment or unreliability.
- Enrollment in any active study involving the use of investigational devices or drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moy-Fincher-Chipps Facial Plastics/Dermatology
Beverly Hills, California, 90210
About this study
Use of RF device to treat wrinkles of the neck
Read the detailed description
This is a prospective study evaluating the safety and efficacy of two treatments, spaced at 30 day intervals, using the Surgitron® Dual RF™ S5 with the Pellevé™ wrinkle treatment handpiece and Pellevé™ treatment gel for the treatment of neck wrinkles.
- Conditions
- Facial and Neck Rhytides
- Being tested
- Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator
- Keywords
- wrinkles, rhytides
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generatorDevice
two treatments spaced 30 days apart
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | All subjects enrolled were in the treatment group. Receives: Device: Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment
Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study.
The measurement is for percentage of patients who showed improvement
Measured: 90 days post treatment
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The rate of adverse events will be assessed throughout the duration of the study
Measured: 90 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial and Neck RhytidesStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellman International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Chipps, MD, Principal investigator, Moy-Fincher-Chipps Facial Plastics/Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299090
- Sponsor's protocol ID
- PEL-09-02
- Status last verified
- Mar 2016
- First submitted
- 4 Feb 2011
- Last updated
- 27 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pellevé™ Neck Wrinkle Study
- ClinicalTrials.gov ID
- NCT01299090
- Acronym / sponsor ID
- PEL-09-02
- Conditions
- Facial and Neck Rhytides
- Keywords
- wrinkles, rhytides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ellman InternationalIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of RF device to treat wrinkles of the neck
Detailed description
This is a prospective study evaluating the safety and efficacy of two treatments, spaced at 30 day intervals, using the Surgitron® Dual RF™ S5 with the Pellevé™ wrinkle treatment handpiece and Pellevé™ treatment gel for the treatment of neck wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generatorAll subjects enrolled were in the treatment group. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 30-70 years of age
- Subjects with clinical evidence of neck wrinkles moderate to severe in severity as specified by a grade 4-9 on the Fitzpatrick Wrinkle Assessment Scale.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Willingness and ability to provide written photo consent and adherence to photography procedures(i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Key exclusion criteria (21 listed)
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study.
- Subjects who have had prior exposure to any botulinum toxin for rhytids in the treatment area in the 6 months preceding study enrollment through the duration of the study.
- Subjects who have had a prior cosmetic procedure to improve rhytids in the treatment area (i.e.,rhytidectomy, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment)within 12 months or who have visible scars that may affect evaluation of response and/or quality of photography.
- Microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study.
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 |
|---|---|---|
| Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generatortwo treatments spaced 30 days apart | Device | Treatment Group |
Primary outcome
Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment
Time frame: 90 days post treatment
Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study. The measurement is for percentage of patients who showed improvement
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 90 days post treatment
The rate of adverse events will be assessed throughout the duration of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lisa Chipps, MD principal investigator
Moy-Fincher-Chipps Facial Plastics/Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator in people with Facial and Neck Rhytides, run by Ellman International at 1 site 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 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 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment (time frame: 90 days post treatment). 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 27 Apr 2016.