Clinical trial NCT04599751: The Trio Laser Module for Hair Removal Treatment
Official title: The Safety and Efficacy of Trio Diode Laser Module for Hair Removal Treatment in All Skin Types
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Removal Treatment
Lead sponsor: Alma Lasers
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in hair count
timeFrame: 3 month after the last treatment
measure: Safety- Adverse events
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Investigator's assessment of the tolerability to the treatment using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").
timeFrame: up to 24 weeks
measure: Subject's tolerability to the treatment, using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").
timeFrame: up to 24 weeks
measure: Subject treatment related pain assessment, using VAS ( when "0" indicates "no pain" and "10" " worst possible pain"
timeFrame: up to 24 weeks
measure: Subject's satisfaction from the treatment, using a 5-point Likert scale (when "1" indicates very dissatisfied and "5" very satisfied)
timeFrame: 3 months after the last treatment
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
Study officials:
affiliation: Tennessee Clinical Research Center
name: Michael Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Care Research, LLC
name: Edwardo Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: