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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
The procedure will include an intense pulse light (M22 IPL) treatment followed by fractional non-ablative (M22 ResurFX) treatment.
Knight Dermatology Institute
Orlando, Florida, United States
Unnamed facility
Konz, Rhineland-Palatinate, Germany
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
Time frame: 3 months following 3rd treatment
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
Time frame: 1 and 6 months following 3rd treatment
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.
Time frame: Following treatments- Baseline, 4, 8 weeks
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.
Time frame: Following treatment- baseline, 4, 8 weeks
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".
Time frame: Following treatment- baseline, 4, 8 weeks
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.
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Time frame: Following treatments- 4, 8 weeks and 1, 3 and 6 months follow up
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.
Time frame: Following treatment #1, 2 and 3 and all follow up visits