Skin ResurfacingNCT00887913

Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction

A study testing Fractional RF treatment with Matrix RF applicator in people with Skin Resurfacing and Wrinkle Reduction, run by Syneron Medical at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether the Matrix RF applicator is effective in the treatment of facial skin texture and wrinkle reduction. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Skin Resurfacing, Wrinkle Reduction
What is being tested?: Fractional RF treatment with Matrix RF applicator
Type of treatment: Medical device
How many people: 69 participants
Where: 3 sitesin 2 countries
Study dates: Apr 2008to Oct 2009
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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Informed consent agreement signed by the subject.
Healthy males or females older than 21 years of age.
Having at least two facial sub-areas with visible lines/wrinkles and elastosis, which correlate to a score of 2 6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
Fitzpatrick skin type I-VI (note: skin type VI should not undergo treatment using resurfacing procedure parameters).
Willingness to follow the treatment and follow-ups schedule and the post-treatment care.
For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).

Who cannot join

Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding.
Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
Having a permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
Having received acne treatment with a light-based device within 1 month of treatment or during the study.
Use of isotretinoin (Accutane®) within 6 months of treatment or during the study.

Show all 26Show fewer

Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
Use of retinoids, antioxidants or skin nourishing supplements within 2 months of treatment or during the study.
Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study.
Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
Having received Botox/collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study.
Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study.
Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
History of keloid scarring or of abnormal wound healing.
Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), indurate acne, varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
Suffering from hormonal imbalance, as per the Investigator's discretion.
Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
Vascular lesion, tattoo or permanent make-up in the treated area.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
Participation in a study of another device or drug within one month prior to enrollment or during the study.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Laser and Dermatology Surgery Center
Chesterfield, Missouri, 63017
Advanced Dermatology
Lincolnshire, Illinois, 60069

Other trials in United States

Canada1 site

Laserderm
Ottawa, Ontario, K1Z 1G3

Other trials in Canada

About this study

The purpose of this study is to determine whether the Matrix RF applicator is effective in the treatment of facial skin texture and wrinkle reduction.

Conditions: Skin Resurfacing, Wrinkle Reduction
Being tested: Fractional RF treatment with Matrix RF applicator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fractional RF treatment with Matrix RF applicatorDevice
Also called Matrix RF Applicator
3 treatments, single pass, 2-50J

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in Fine Lines
Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome.
Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up
Measured: 4 week follow up after last treatment
Improvement in Smoothness
Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome.
Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up
Measured: 4 weeks follow up post last treatment
Improvement in Brightness
Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome.
Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up
Measured: 4 week follow up post last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Oct 2009

First posted24 Apr 2009 (estimated)
Study startApr 2008
Primary completionDec 2008
Study completionOct 2009

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 Skin ResurfacingStudies 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: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00887913
Sponsor's protocol ID: Matrix RF_Facial Tx
Status last verified: Nov 2010
First submitted: 23 Apr 2009
Last updated: 30 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
ClinicalTrials.gov ID: NCT00887913
Acronym / sponsor ID: Matrix RF_Facial Tx
Conditions: Skin Resurfacing, Wrinkle Reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Syneron MedicalIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Dec 2008 (actual)
Study completion: Oct 2009 (actual)
First posted: 24 Apr 2009 (estimated)
Results: Posted 30 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether the Matrix RF applicator is effective in the treatment of facial skin texture and wrinkle reduction.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Informed consent agreement signed by the subject.
Healthy males or females older than 21 years of age.
Having at least two facial sub-areas with visible lines/wrinkles and elastosis, which correlate to a score of 2 6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
Fitzpatrick skin type I-VI (note: skin type VI should not undergo treatment using resurfacing procedure parameters).
Willingness to follow the treatment and follow-ups schedule and the post-treatment care.

Key exclusion criteria (26 listed)

Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding.
Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
Having a permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
Having received acne treatment with a light-based device within 1 month of treatment 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
Fractional RF treatment with Matrix RF applicatorAlso: Matrix RF Applicator3 treatments, single pass, 2-50J	Device	–

Primary outcome

Improvement in Fine Lines
Time frame: 4 week follow up after last treatment
Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up
Improvement in Smoothness
Time frame: 4 weeks follow up post last treatment
Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up
Improvement in Brightness
Time frame: 4 week follow up post last treatment
Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up

Results and safety

Results posted to the registry on 30 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	69	63

Primary outcome: Improvement in Fine Lines

Time frame: 4 week follow up after last treatment. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Treatment n = 63
Value	1.77 (0.98)

Population analysed: Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4

Primary outcome: Improvement in Smoothness

Time frame: 4 weeks follow up post last treatment. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Treatment n = 63
Value	1.90 (1.05)

Population analysed: Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin

Primary outcome: Improvement in Brightness

Time frame: 4 week follow up post last treatment. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Treatment n = 63
Value	1.68 (1.18)

Population analysed: Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0.

Adverse events

Time frame: Adverse event data was collected for the duration of the study, up to 5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 63 (0%)	0 of 63 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fractional RF treatment with Matrix RF applicator in people with Skin Resurfacing and Wrinkle Reduction, run by Syneron Medical at 3 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 6 inclusion and 26 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 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. 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 30 Nov 2010). 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?

Improvement in Fine Lines (time frame: 4 week follow up after last treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00887913.

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 30 Nov 2010.