This study is being conducted to evaluate the safety and efficacy of a laser called the SR-1 Skin Treatment System, or SR-1 Laser, for the treatment of wrinkles and pigmented spots. Participants will be treated with the SR-1 Laser 3 or 4 times with each treatment spaced 4-6 weeks apart. The improvement in wrinkles and pigmented spots will be evaluated 1 and 3 months after the final treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
3-4 treatments at 4-6 week intervals
AVAVA, Inc.
Waltham, Massachusetts, United States
Improvement in facial wrinkles
A 1 point or greater reduction in facial wrinkle severity using the Fitzpatrick Wrinkle and Elastosis Scale (FWS), as assessed, and agreed upon by at least two of three blinded independent reviewers in at least 70% of subjects as determined with a side-by-side evaluation of baseline and post-treatment photographs. The FWS scores range from 1 to 9 with lower numbers representing less severe wrinkles.
Time frame: 3 months after the final treatment
Reduction of pigmentation in benign pigmented lesions (BPL)
If clinically identifiable BPL were present at baseline, a greater than 25% reduction in pigmentation of BPL (including, but not limited to, lentigos, solar lentigos, ephelides, and melasma) as assessed, and agreed upon, by at least two of three blinded independent reviewers in at least 50% of subjects as determined with a side-by-side evaluation of baseline and post-treatment photographs.
Time frame: 3 months after the final treatment
Subject satisfaction with the improvement in wrinkles
The percent of subjects satisfied with the improvement in fine lines and wrinkles in the treated areas will be assessed using a Likert scale with responses ranging from "very dissatisfied" to "very satisfied".
Time frame: 1 and 3 months after the final treatment
Subject satisfaction with the improvement in BPL
The percent of subjects satisfied with the improvement in BPL pigmentation will be assessed among subjects with clinically identifiable BPL present at baseline using a Likert scale with responses ranging from "very dissatisfied" to "very satisfied".
Time frame: 1 and 3 months after the final treatment
Tolerance of procedure
Subject tolerance of the procedure based on pain scores during treatment per the 1-10 Visual Analog Scale.
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Time frame: during treatment
Adverse Events
The incidence and severity of adverse events
Time frame: 3 months after the final treatment
Overall improvement
Rate of overall improvement in facial wrinkles and BPL in the treated area(s) as assessed by the investigator using the Global Aesthetic Improvement Scale (GAIS). Wrinkles and BPL will be considered together and one overall score will be created. Scores on the GAIS range from 0 to 4 which correspond to "worsening of conditions", "no improvement in conditions", "mild improvement in conditions", "moderate improvement in conditions", and "significant improvement in conditions".
Time frame: 1 and 3 months after the final treatment