WrinklesNCT01796626

Clinical Evaluation of M22 ResurFX 1565nm Module

A study testing M22 ResurFX module in people with Wrinkles and Striae, run by Lumenis Be Ltd. at 2 sites in United States.

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

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects. Subjects should present visible wrinkles and/or striae requiring treatment. Read more about this study

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Wrinkles, Striae
What is being tested?: M22 ResurFX module
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 2 sitesUnited States
Study dates: Dec 2012to Jul 2014
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 25 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to read, understand and provide written Informed Consent;
Healthy adult, male or female, 25-55 years of age with Fitzpatrick-Goldman skin type I-IV;
Having suitable areas of treatment of facial areas to be treated with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 or striae alba present for more than 1 year;
Able and willing to comply with the treatment/follow-up schedule and requirements;
Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to enrollment and throughout the course of the study.

Who cannot join

Any of the following will exclude the subject from the study: skin type V-VI
Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding;
History of post inflammatory hyperpigmentation
Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;
Use of photosensitive medication for which light exposure is contraindicated.
Use of oral isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study. Note: skin must regain its normal degree of moisture prior to treatment;

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Prior treatment, such as chemical peel (especially phenol based) or dermabrasion, in treated area within 3 months of initial treatment or during the course of the study;
Prior skin treatment with non-ablative laser or other devices in treated area within 6 months of initial treatment or during the course of the study;
Prior use of collagen, fat injections or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 12 months of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants;
Prior use of Botox in treatment area within 6 months;
Prior ablative resurfacing procedure or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study;
Any other surgery in treated area within 9 months of initial treatment or during the course of the study;
History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area;
Showing symptoms of hormonal disorders, as per the Investigator's discretion (such as Melasma, Chloasma);
Concurrent inflammatory skin conditions, including, but not limited to, rosacea of any severity;
Open laceration or abrasion of any sort on area to be treated during the course of treatment;
Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment;
Multiple dysplastic nevi in area to be treated;
Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to treatment (as per the patient's physician discretion);
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
Having any form of active cancer at the time of enrollment and during the course of the study or history or skin cancer;
Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process; Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's discretion, as long as not contradictory to any of the above criteria;
Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

New York Laser & Skin Care
New York, New York, 10028
DCLA
San Diego, California

Other trials in United States

About this study

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects.

Subjects should present visible wrinkles and/or striae requiring treatment.

Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least 50% using VAS as compared to baseline, for at least 75% of the subjects.

Conditions: Wrinkles, Striae
Being tested: M22 ResurFX module
Medical subject headings: Striae Distensae

What participants receive

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

M22 ResurFX moduleDevice
The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.

Study groups in NCT01796626
Study group	Role	What they receive
Wrinkle treatment	Experimental	Wrinkle treatment with ResurFX 1565nm module Receives: Device: M22 ResurFX module
Striae treatment	Experimental	Striae treatment with the REsurFX 1565nm module Receives: Device: M22 ResurFX module

What is being measured

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

Improvement
Investigator subjective evaluation of the extent of wrinkles improvement at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS.
Measured: 3 months following 3rd treatment

Secondary outcomes (8)

Improvement
Investigator subjective evaluation of the extent of wrinkles/striae improvement by the investigator at 1 and 6 month follow-up visits as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS.
Measured: 1 and 6 months following 3rd treatment
Blinded improvement
Blinded evaluation of wrinkles/striae skin improvement at the 1, 3 and 6 months follow-up as compared to baseline using photographs may be performed at the end of the study.
Measured: 1 year following study initiation
Skin response
Investigator subjective evaluation of skin response following each treatment defined as severity of response and the time it took for it subside
Measured: Following treatment #1, 2 and 3
Downtime
Downtime defined as the period of time following the procedure during which the subject felt uncomfortable, unwilling or unable to go out in public due to edema and erythema
Measured: Following treatment #1, 2 and 3
Improvement by subject
Subject subjective opinion of improvement and satisfaction with the treatment based on a 5 point scale
Measured: 1, 3 and 6 months follow up
Comfort
Subject subjective assessment of pain and discomfort associated with treatments using a 10 point VAS scale
Measured: Following treatment #1, 2 and 3
Biopsies
Histological analysis of tissue samples with different staining for analysis of changes following treatment
Measured: 1, 3 and 6 months follow up
Adverse Events
Any adverse events associated with various setting used during the treatment and follow-up period.
Measured: Following treatment #1, 2 and 3 and all follow up visits

Timeline

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

Dec 2012Jul 2014

First posted22 Feb 2013 (estimated)
Study startDec 2012
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01796626
Sponsor's protocol ID: LUM-ABU-M22-ResurFX-12-01
Status last verified: Aug 2014
First submitted: 17 Feb 2013
Last updated: 26 Aug 2014
Results posted: No
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?

See locations

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All Wrinkles trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of M22 ResurFX 1565nm Module
ClinicalTrials.gov ID: NCT01796626
Acronym / sponsor ID: LUM-ABU-M22-ResurFX-12-01
Conditions: Wrinkles, Striae
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Lumenis Be Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 22 Feb 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.

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects.

Subjects should present visible wrinkles and/or striae requiring treatment.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Wrinkle treatment	Experimental	Device: M22 ResurFX moduleWrinkle treatment with ResurFX 1565nm module
Striae treatment	Experimental	Device: M22 ResurFX moduleStriae treatment with the REsurFX 1565nm module

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Able to read, understand and provide written Informed Consent;
Healthy adult, male or female, 25-55 years of age with Fitzpatrick-Goldman skin type I-IV;
Having suitable areas of treatment of facial areas to be treated with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 or striae alba present for more than 1 year;
Able and willing to comply with the treatment/follow-up schedule and requirements;
Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to enrollment and throughout the course of the study.

Key exclusion criteria (24 listed)

Any of the following will exclude the subject from the study: skin type V-VI
Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding;
History of post inflammatory hyperpigmentation
Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;
Use of photosensitive medication for which light exposure is contraindicated.

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
M22 ResurFX moduleThe system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.	Device	Striae treatment, Wrinkle treatment

Primary outcome

Improvement
Time frame: 3 months following 3rd treatment
Investigator subjective evaluation of the extent of wrinkles improvement at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS.

8 secondary outcomes

Improvement
Time frame: 1 and 6 months following 3rd treatment
Blinded improvement
Time frame: 1 year following study initiation
Skin response
Time frame: Following treatment #1, 2 and 3
Downtime
Time frame: Following treatment #1, 2 and 3
Improvement by subject
Time frame: 1, 3 and 6 months follow up
Comfort
Time frame: Following treatment #1, 2 and 3
Biopsies
Time frame: 1, 3 and 6 months follow up
Adverse Events
Time frame: Following treatment #1, 2 and 3 and all follow up visits

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 26 Aug 2014.

Related trials for Wrinkles

Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
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Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies

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.

Mitchel P Goldman, MD principal investigator

DCLA

Arielle NB Kauvar, MD study director

New York Laser & Skin Care

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing M22 ResurFX module in people with Wrinkles and Striae, run by Lumenis Be Ltd. 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 24 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 26 Aug 2014. 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?

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?

Improvement (time frame: 3 months following 3rd treatment). 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 NCT01796626.

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 26 Aug 2014.