Photodamage Clinical Trial
Official title:
Laser 360iQ: Optimal Light-laser Combination Therapy for the Improvement of Skin Color, Tone, Texture and Laxity.
To assess the safety and efficacy of light-laser combination therapy for the improvement of skin color, tone, texture and laxity
This is a prospective study to test the safety and efficacy of a three different light and
laser handpieces for the improvement of skin color, tone, texture and laxity. All subjects
will receive up to four treatments, administered in intervals of 28 +/- 2 days. Each full
face treatment duration will be approximately 60 minutes. The initial power and number of
passes parameters shall be set according to the clinical indication and skin type of the
subject treated. The treatment area will be cleaned and photographed before each treatment.
Photographs will be taken at baseline, prior to each treatment and during each follow-up
visit. Before the initiation of the first treatment each subject will undergo clinical
evaluation.
Clinical improvement will be assessed by the investigator from the visual appearance of the
treated area and from the fixed magnification clinical photographs according to the following
scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement,
3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored
by clinical evaluation of erythema, edema, and burns. Treatments and results will be
documented in a Case Report Form at each treatment session and follow-up session (1 month and
3 months after the last treatment). In case of adverse side effects and symptoms other than
erythema or edema appear during or following a treatment, the next treatment may be skipped
by two weeks or treatment parameters reduced until symptoms resolve. If adverse side effects
are observed, the investigator should provide the subject with the proper care and remedy and
will document it in the Case Report Form.
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