Improvement of Wrinkles/Elastosis as Well as General Skin ToneNCT01940445

Impact of Synergistic Sequential Treatment (SST)

A study testing M22 ResurFX and M22 ResurFX and QS in people with Improvement of Wrinkles/Elastosis as Well as General Skin Tone, run by Lumenis Be Ltd. at 1 site 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 II-V will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects. Subjects should present visible wrinkles and/or elastosis requiring treatment. Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Improvement of Wrinkles/Elastosis as Well as General Skin Tone
What is being tested?: M22 ResurFX and M22 ResurFX and QS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Jun 2015
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 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to read, understand and provide written Informed Consent;
Healthy adult, male or female, 30-65 years of age with Fitzpatrick-Goldman skin type II-V;
Having suitable facial areas with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 to be treated;
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 (such as an intrauterine device, birth control pills, condom with spermicidal, Nova ring, partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.

Who cannot join

Skin type I, 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 3 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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Having indurate acne, varicella scars, or severe open wound stages of rosacea.
Any dermal/epidermal damage or disorder, mainly vascular or textural lesions, in treated area
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 laser/light or another device treatment 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.
Participation in a study of another investigational device or drug involving the same anatomical site within 3 months prior to enrollment or during this evaluation, or if not involving the same anatomical site, as per the Investigator's discretion
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, severe rosacea
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 subject'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 of skin cancer on the face.
Pigmented lesion in the treated area that appears cancerous, pre-cancerous or is not deemed suitable for photo therapy, as determined by a dermatologist.
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.
For subjects undergoing test spots: considerable undesired response consisting of skin hypopigmentation (long term whitening), a scar or pre scar formation, or any response deemed by the Investigator as grounds for exclusion.
Allergies to anesthetics.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207

Other trials in United States

About this study

Official title: Impact of Synergistic Sequential Treatment (SST) of Fractional Non-ablative and Q-Switched Lasers on Skin Texture

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

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

Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75% of the subjects.

Conditions: Improvement of Wrinkles/Elastosis as Well as General Skin Tone
Being tested: M22 ResurFX, M22 ResurFX and QS

What participants receive

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

M22 ResurFXDevice
Fractional NA treatment (ResurFX) on one side of the face
M22 ResurFX and QSDevice
Fractional NA treatment followed by QS laser treatment (SST) on one side of the face

Study groups in NCT01940445
Study group	Role	What they receive
ResurFX treatment	Experimental	Fractional Non Ablative (NA) treatment on one side of the face with the M22 ResurFX module Receives: Device: M22 ResurFX
M22 ResurFX and QS treatment	Experimental	Fractional NA treatment with the M22 ResurFX followed by Q-Switched (QS) laser treatment (SST) on one side of the face Receives: Device: M22 ResurFX and QS

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/elastosis as well as general skin tone improvement of each side of the face at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification and by percentage category scales
Measured: 3 months following 3rd treatment

Secondary outcomes (8)

Improvement
Investigator subjective evaluation of the extent of wrinkles/elastosis as well as general skin tone improvement of each side of the face at 1 and 6 month follow-up visits as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification and by percentage category scales
Measured: 1 and 6 months following 3rd treatment
Blinded improvement
Blinded evaluation of wrinkles and general skin tone improvement at the 1, 3 and 6 months follow-up as compared to baseline using photographs will 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 for each side of the face
Measured: Following treatments- Baseline, 4, 8 weeks
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 for each side of the face
Measured: Following treatment- baseline, 4, 8 weeks
Improvement by subject
Subject subjective opinion of improvement and satisfaction with the treatment based on a percentage category scale for each side of the face
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 for each side of the face
Measured: Following treatment- baseline, 4, 8 weeks
Biopsies
Histological analysis of pre auricular tissue samples from both treatment sides with different staining for analysis of changes following treatment
Measured: Immediately post 1st treatment or at 1, 3 or 6 month post last treatment
Adverse Events
Safety will be determined by examining the post-treatment occurrences of complications and adverse events throughout the study.
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.

Sep 2013Jun 2015

First posted12 Sep 2013 (estimated)
Study startSep 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Improvement of Wrinkles/Elastosis as Well as General Skin ToneStudies 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: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01940445
Sponsor's protocol ID: LUM-ABU-M22-13-01
Status last verified: Jan 2017
First submitted: 8 Sep 2013
Last updated: 26 Jan 2017
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Synergistic Sequential Treatment (SST) of Fractional Non-ablative and Q-Switched Lasers on Skin Texture
ClinicalTrials.gov ID: NCT01940445
Acronym / sponsor ID: LUM-ABU-M22-13-01
Conditions: Improvement of Wrinkles/Elastosis as Well as General Skin Tone
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Lumenis Be Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 12 Sep 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 II-V will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects.

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

Study design

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

Arm	Type	Receives
ResurFX treatment	Experimental	Device: M22 ResurFXFractional Non Ablative (NA) treatment on one side of the face with the M22 ResurFX module
M22 ResurFX and QS treatment	Experimental	Device: M22 ResurFX and QSFractional NA treatment with the M22 ResurFX followed by Q-Switched (QS) laser treatment (SST) on one side of the face

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Able to read, understand and provide written Informed Consent;
Healthy adult, male or female, 30-65 years of age with Fitzpatrick-Goldman skin type II-V;
Having suitable facial areas with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 to be treated;
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 (such as an intrauterine device, birth control pills, condom with spermicidal, Nova ring, partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.

Key exclusion criteria (30 listed)

Skin type I, 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 ResurFXFractional NA treatment (ResurFX) on one side of the face	Device	ResurFX treatment
M22 ResurFX and QSFractional NA treatment followed by QS laser treatment (SST) on one side of the face	Device	M22 ResurFX and QS treatment

Primary outcome

Improvement
Time frame: 3 months following 3rd treatment
Investigator subjective evaluation of the extent of wrinkles/elastosis as well as general skin tone improvement of each side of the face at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification and by percentage category scales

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 treatments- Baseline, 4, 8 weeks
Downtime
Time frame: Following treatment- baseline, 4, 8 weeks
Improvement by subject
Time frame: 1, 3 and 6 months follow up
Comfort
Time frame: Following treatment- baseline, 4, 8 weeks
Biopsies
Time frame: Immediately post 1st treatment or at 1, 3 or 6 month post last treatment
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 Jan 2017.

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.

Girish (Gilly) Munavalli, MD principal investigator

Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC

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

Questions about this trial

What is this clinical trial studying?

A study testing M22 ResurFX and M22 ResurFX and QS in people with Improvement of Wrinkles/Elastosis as Well as General Skin Tone, run by Lumenis Be Ltd. 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 30 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 Jan 2017. 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?

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 NCT01940445.

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 Jan 2017.