Appearance of Facial WrinklesNCT01299103
Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles
A study testing Pelleve Wrinkle Treatment System in people with Appearance of Facial Wrinkles, run by Ellman International at 1 site in United States.
Trial summary
The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appearance of Facial Wrinkles
- What is being tested?
- Pelleve Wrinkle Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2012
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females 35-60 years of age with Fitzpatrick Skin Color Type I-IV.
- Subjects with clinical evidence of facial wrinkles mild to moderate in severity as specified by a grade 4-6 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 facial rhytids in the 6 months preceding study enrollment through the duration of the study.
- Subjects who have had a prior cosmetic procedure to improve facial rhytids (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, 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.
- Ablative skin resurfacing on the glabellar area within the previous 6 months or during the study.
- Retinoid, microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study.
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- Active cut, wound, or infection on the skin.
- Oral Isotretinon within the past 12 months.
- Active HSV-1.
- History of keloids or hypertrophic scarring.
- Existing or history of skin malignancy.
- Any existing skin disease.
- 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, non¬compliance 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.
About this study
Official title: A Prospective, Randomized, Open-Label, 3-Arm Parallel Study Comparing the Safety and Efficacy of Single Therapy Versus Double and Triple Therapy Using the Surgitron® Dual RF™ S5 With the Pellevé™ Wrinkle Treatment Handpiece and Pellevé™ Treatment Gel for the Treatment of Moderate Facial Wrinkles in Fitzpatrick Skin Types I - IV
The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.
Read the detailed description
The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a single treatment and 21 in treatment Group B receiving two treatments) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.
- Conditions
- Appearance of Facial Wrinkles
- Being tested
- Pelleve Wrinkle Treatment System
- Keywords
- wrinkle, rhytide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelleve Wrinkle Treatment SystemDevice
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
| Study group | Role | What they receive |
|---|---|---|
| Single Treatment | Active comparator | Treatment of facial wrinkle with one treatment only Receives: Device: Pelleve Wrinkle Treatment System |
| Double Treatment | Active comparator | Treatment of facial wrinkle with two treatments Receives: Device: Pelleve Wrinkle Treatment System |
| Triple treatment | Active comparator | Treatment of facial wrinkle with three treatments Receives: Device: Pelleve Wrinkle Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitzpatrick Wrinkle Assessment
Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease
Measured: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.
Adverse Events
The rate of adverse events occurring in treatment subjects will be assessed.
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 startApr 2010
- Primary completionApr 2012
- Study completionApr 2012
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 Appearance of 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellman International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven H. Dayan, MD, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299103
- Sponsor's protocol ID
- PEL-10-02
- Status last verified
- Mar 2016
- First submitted
- 4 Feb 2011
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, 3-Arm Parallel Study Comparing the Safety and Efficacy of Single Therapy Versus Double and Triple Therapy Using the Surgitron® Dual RF™ S5 With the Pellevé™ Wrinkle Treatment Handpiece and Pellevé™ Treatment Gel for the Treatment of Moderate Facial Wrinkles in Fitzpatrick Skin Types I - IV
- ClinicalTrials.gov ID
- NCT01299103
- Acronym / sponsor ID
- PEL-10-02
- Conditions
- Appearance of Facial Wrinkles
- Keywords
- wrinkle, rhytide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ellman InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 15 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.
Detailed description
The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a single treatment and 21 in treatment Group B receiving two treatments) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Treatment | Active comparator | Device: Pelleve Wrinkle Treatment SystemTreatment of facial wrinkle with one treatment only |
| Double Treatment | Active comparator | Device: Pelleve Wrinkle Treatment SystemTreatment of facial wrinkle with two treatments |
| Triple treatment | Active comparator | Device: Pelleve Wrinkle Treatment SystemTreatment of facial wrinkle with three treatments |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females 35-60 years of age with Fitzpatrick Skin Color Type I-IV.
- Subjects with clinical evidence of facial wrinkles mild to moderate in severity as specified by a grade 4-6 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 (22 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 facial rhytids in the 6 months preceding study enrollment through the duration of the study.
- Subjects who have had a prior cosmetic procedure to improve facial rhytids (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, 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.
- Ablative skin resurfacing on the glabellar area within the previous 6 months 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 Systemcomparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System | Device | Double Treatment, Single Treatment, Triple treatment |
Primary outcome
Fitzpatrick Wrinkle Assessment
Time frame: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.
Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease
Adverse Events
Time frame: 90 days post treatment
The rate of adverse events occurring in treatment subjects will be assessed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Facial Aging, Wrinkles
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.
Steven H. Dayan, MD principal investigator
DeNova Research
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 in people with Appearance of Facial Wrinkles, 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 22 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 15 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 15 Apr 2016). 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?
Fitzpatrick Wrinkle Assessment (time frame: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.). 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 15 Apr 2016.