The study is aimed to assess the safety and efficacy of hair removal treatments, using the Trio Laser Module (Alma Lasers). The study will include 36 subjects that will undergo axilla and bikini line hair removal treatments. Safety and efficacy will be evaluated 3- months after the last treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).
Skin Care Research, LLC
Hollywood, Florida, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Change in hair count
Change in hair count, preformed by blinded evaluators, based on photographs taken at 3m FU visit compared to baseline
Time frame: 3 month after the last treatment
Safety- Adverse events
Adverse events and serious AE reported at any time during the trial or follow-up
Time frame: Through study completion, an average of 1 year
Investigator's assessment of the tolerability to the treatment using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").
The investigator will assess the treatment area and score treatment related side effects using a 5-point likert scale, before and after the treatment
Time frame: up to 24 weeks
Subject's tolerability to the treatment, using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").
Subjects will be requested to scale any sensation of stinging, tingling, itching and, burning using the 5-point Likert scale, before and after the treatment
Time frame: up to 24 weeks
Subject treatment related pain assessment, using VAS ( when "0" indicates "no pain" and "10" " worst possible pain"
Subjects will be requested to scale their treatment related pain
Time frame: up to 24 weeks
Subject's satisfaction from the treatment, using a 5-point Likert scale (when "1" indicates very dissatisfied and "5" very satisfied)
Subjects will be requested to scale their satisfaction from the treatment
Time frame: 3 months after the last treatment
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