An interventional study of M22 ResurFX and M22 ResurFX and QS in Improvement of Wrinkles/Elastosis as Well as General Skin Tone, sponsored by Lumenis Be Ltd.. Completed at 1 site in United States. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-26.
Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment
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.
Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fractional Non Ablative (NA) treatment on one side of the face with the M22 ResurFX module
Device: M22 ResurFX
Fractional NA treatment with the M22 ResurFX followed by Q-Switched (QS) laser treatment (SST) on one side of the face
Device: M22 ResurFX and QS
Fractional NA treatment (ResurFX) on one side of the face
Fractional NA treatment followed by QS laser treatment (SST) on one side of the face
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
Time frame: 3 months following 3rd treatment
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Following treatment #1, 2 and 3 and all follow up visits
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Lumenis Be Ltd.