The Trio Laser Module for Hair Removal Treatment

NCT04599751 | Completed FDA Device

• 1 other identifier: ALM-Trio-20-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Hair Removal Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Investigator's assessment of the tolerability to the treatment using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").

  up to 24 weeks

• Subject's tolerability to the treatment, using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").

  up to 24 weeks

• Subject treatment related pain assessment, using VAS ( when "0" indicates "no pain" and "10" " worst possible 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)

  3 months after the last treatment

Study Arms (1)

Hair removal treatment

EXPERIMENTAL

Trio laser module (Alma Lasers)

Device: Hair removal treatment

Interventions

Hair removal treatment DEVICE

Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).

Hair removal treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alma Lasers: lead

Study Sites (2)

Skin Care Research, LLC

Hollywood, Florida, 33021, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Study Officials

• Michael Gold, MD

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Edwardo Weiss, MD

  Skin Care Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 23, 2020
• Study Start: October 7, 2020
• Primary Completion: October 7, 2021
• Study Completion: November 16, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

US (2)