The Trio Laser Module for Hair Removal Treatment

Alma Lasers

Status

Completed

Conditions

Hair Removal Treatment

Treatments

Device: Hair removal treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT04599751

ALM-Trio-20-001

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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