Impact of M22 Synergistic Sequential Treatment (SST)
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|ClinicalTrials.gov Identifier: NCT02032771|
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : September 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Improvement of Wrinkles/Elastosis and/or Pigmentation||Device: M22 IPL and ResurFX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of M22 Synergistic Sequential Treatment (SST) Using Intense Pulsed Light and Fractional Non-ablative Photothermolysis on Skin Texture|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: M22 IPL and ResurFX
The procedure will include an intense pulse light (IPL) treatment followed by fractional non-ablative (FNA) treatment.
Device: M22 IPL and ResurFX
The procedure will include an intense pulse light (M22 IPL) treatment followed by fractional non-ablative (M22 ResurFX) treatment.
- Percentage of Participants with ≥ 50% improvement in Fitzpatrick Elastosis Scale (FES) [ Time Frame: 3 months following 3rd treatment ]Skin improvement by Fitzpatrick Elastosis Scale (FES) or category scale at 3 months based on before/after photos
- Percentage of Participants with ≥ 50% improvement in Fitzpatrick Elastosis Scale (FES) [ Time Frame: 1 and 6 months following 3rd treatment ]Overall skin improvement at 1 and 6 months by subject and investigator evaluation compared to baseline using the category global aesthetic improvement (GAI) scale
- Change in erythema/ edema/ purpura and the response intensity [ Time Frame: Following treatments- Baseline, 4, 8 weeks ]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.
- Downtime in days [ Time Frame: Following treatment- baseline, 4, 8 weeks ]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.
- Subject Comfort using a Pain Visual Analogue Scale (VAS) [ Time Frame: Following treatment- baseline, 4, 8 weeks ]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".
- Subject subjective assessment of improvement using categorical improvement scales [ Time Frame: Following treatments- 4, 8 weeks and 1, 3 and 6 months follow up ]Subject subjective opinion of improvement and satisfaction with the treatment using the global aesthetic improvement (GAI) scale and pigment Improvement score.
- Number of Participants with Adverse Events [ Time Frame: Following treatment #1, 2 and 3 and all follow up visits ]Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032771
|United States, Florida|
|Knight Dermatology Institute|
|Orlando, Florida, United States, 32801|
|Konz, Rhineland-Palatinate, Germany, 54329|