The Trio Laser Module for Hair Removal Treatment

Completed · Not applicable

Conditions studied: Hair Removal Treatment

In brief

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.

Key facts

Study ID

NCT04599751

Run by

Alma Lasers

People needed

37

Starts

2020-10-07

Expected to finish

2021-11-16

Last updated by the study team

2021-11-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Skin Care Research, LLC — Hollywood, Florida, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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