The Trio Laser Module for Hair Removal Treatment

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy of Trio Diode Laser Module for Hair Removal Treatment in All Skin Types

Conditions
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Hair Removal Treatment

Intervention / Treatment
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* Device: Hair removal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to undergo hair removal treatments at the Axilla and the Bikini line. Between 18 and 70 years of age. Reasonably good health, as defined by the Investigator. Agrees to avoid tanning during their participation in this study. Agrees to shave the treatment area prior to the treatment visit, according to the investigator's instructions. Subjects with dark brown hair. Eligible for treatment following a test spot without negative effects. Provided written Informed Consent and photo consent. Exclusion Criteria: History of laser hair removal in the treatment area. Pregnant, lactating or planning to get pregnant within the study period. Unwilling to use a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, if of childbearing age. History of photosensitivity or use of medication with photosensitizing properties. Active infection in the treatment area. History or evidence of any chronic or reoccurring skin disease or disorder affecting the treatment area. History of keloid scarring or hypertrophic scar formation. Tattoo in the treatment area. Subject has been tanning within the past 30 days. History of confounding cancerous or pre-cancerous skin lesions in the treatment area. History of connective, metabolic or atrophic skin disease. Subject has used prohibited therapies, oral prescription medication, or topical meds (steroids) on the treatment area within 30 days prior to enrollment. History of autoimmune disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hair removal treatment<br>Trio laser module (Alma Lasers) | Device: Hair removal treatment<br>* Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hair count | Change in hair count, preformed by blinded evaluators, based on photographs taken at 3m FU visit compared to baseline | 3 month after the last treatment | 
| Safety- Adverse events | Adverse events and serious AE reported at any time during the trial or follow-up | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 3 months after the last treatment |