The Trio Laser Module for Hair Removal Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Hair Removal Treatment
• Intervention / Treatment: Device: Hair removal treatment

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Skin Care Research, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alma Lasers
• Investigators: Principal Investigator: Edwardo Weiss, MD, Skin Care Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): October 7, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: October 11, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ALM-Trio-20-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes