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Improvement of Wrinkles/Elastosis and/or PigmentationNCT02032771

Impact of M22 Synergistic Sequential Treatment (SST)

A study testing M22 IPL and ResurFX in people with Improvement of Wrinkles/Elastosis and/or Pigmentation, run by Lumenis Be Ltd. at 2 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

Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of 3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their facial skin appearance. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
What is being tested?
M22 IPL and ResurFX
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesin 2 countries
Study dates
Jan 2014to Feb 2016
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 I-V;
  • Having suitable facial areas with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 to be treated;
  • Having suitable facial areas with mild to moderate age/sun-related facial pigmentation
  • 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 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
  • Heavy smoker (>1 pack of cigarettes a day)
  • 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 in treated area.
  • 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, 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 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;
  • 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

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Knight Dermatology Institute

    Orlando, Florida, 32801

Other trials in United States

Germany1 site

  • Study site

    Konz, Rhineland-Palatinate, 54329

Other trials in Germany

About this study

Official title: Impact of M22 Synergistic Sequential Treatment (SST) Using Intense Pulsed Light and Fractional Non-ablative Photothermolysis on Skin Texture

Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of 3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their facial skin appearance.

Hypothesis: The SST will improve the appearance of the wrinkles/elastosis and/or pigmentation by at least 1 on the FES scale or ≥50% in category scale at 3 months follow-ups in at least 50% of the study population.

Being tested
M22 IPL and ResurFX

What participants receive

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

  • M22 IPL and ResurFXDevice

    The procedure will include an intense pulse light (M22 IPL) treatment followed by fractional non-ablative (M22 ResurFX) treatment.

Study groups in NCT02032771
Study groupRoleWhat they receive
M22 IPL and ResurFXExperimentalThe procedure will include an intense pulse light (IPL) treatment followed by fractional non-ablative (FNA) treatment.
Receives: Device: M22 IPL and ResurFX

What is being measured

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

  1. Percentage of Participants with ≥ 50% improvement in Fitzpatrick Elastosis Scale (FES)

    Skin improvement by Fitzpatrick Elastosis Scale (FES) or category scale at 3 months based on before/after photos

    Measured: 3 months following 3rd treatment

Secondary outcomes (6)

  1. Percentage of Participants with ≥ 50% improvement in Fitzpatrick Elastosis Scale (FES)

    Overall skin improvement at 1 and 6 months by subject and investigator evaluation compared to baseline using the category global aesthetic improvement (GAI) scale

    Measured: 1 and 6 months following 3rd treatment

  2. Change in erythema/ edema/ purpura and the response intensity

    Immediate response (erythema, edema, purpura, etc.) of the skin will be assessed within 20-30 min post treatment by a 5 level scale: (0) None / (1) Trace / (2) Mild / (3) Moderate / (4) Severe.

    Measured: Following treatments- Baseline, 4, 8 weeks

  3. Downtime in days

    Downtime defined as the period of time following the procedure during which the subject felt unable/unwilling to go out in public due to edema and / or erythema.

    Measured: Following treatment- baseline, 4, 8 weeks

  4. Subject Comfort using a Pain Visual Analogue Scale (VAS)

    Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain".

    Measured: Following treatment- baseline, 4, 8 weeks

  5. Subject subjective assessment of improvement using categorical improvement scales

    Subject subjective opinion of improvement and satisfaction with the treatment using the global aesthetic improvement (GAI) scale and pigment Improvement score.

    Measured: Following treatments- 4, 8 weeks and 1, 3 and 6 months follow up

  6. Number of Participants with Adverse Events

    Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events.

    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.

  1. First posted10 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032771
Sponsor's protocol ID
LUM-ABU-M22-IPL&ResurFX-13-02
Status last verified
Sep 2016
First submitted
6 Jan 2014
Last updated
16 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Knight JM, Kautz G. Sequential facial skin rejuvenation with intense pulsed light and non-ablative fractionated laser resurfacing in fitzpatrick skin type II-IV patients: A prospective multicenter analysis. Lasers Surg Med. 2019 Feb;51(2):141-149. doi: 10.1002/lsm.23007. Epub 2018 Aug 8.

    PubMed 30091207

Questions about this trial

What is this clinical trial studying?

A study testing M22 IPL and ResurFX in people with Improvement of Wrinkles/Elastosis and/or Pigmentation, run by Lumenis Be Ltd. at 2 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 29 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 16 Sep 2016. 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, Germany. 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?

Percentage of Participants with ≥ 50% improvement in Fitzpatrick Elastosis Scale (FES) (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 NCT02032771, which also lists 1 linked publication.

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 16 Sep 2016.

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