The Trio Laser Module for Hair Removal Treatment | NCT04599751

Studies
The Trio Laser Module for Hair Removal Treatment

NCT04599751

Sponsor

Alma Lasers

Status

Completed

Last Update Posted

Nov 17, 2021Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Hair Removal Treatment

Interventions

Hair removal treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2020Actual

Primary Completion Date

Oct 7, 2021Actual

Completion Date

Nov 16, 2021Actual

First Submitted Date

Oct 11, 2020

First Submission Date that Met QC Criteria

Oct 18, 2020

First Posted Date

Oct 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2021

Last Update Posted Date

Nov 17, 2021Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hair removal treatment	Experimental	Trio laser module (Alma Lasers)	Device: Hair removal treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hair removal treatment	Device	Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).	Hair removal treatment

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Gold, MD	Tennessee Clinical Research Center	Principal Investigator
Edwardo Weiss, MD	Skin Care Research, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skin Care Research, LLC		Hollywood	Florida	33021	United States
Tennessee Clinical Research Center

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 2, 2022			Dec 1, 2022	5
Dec 6, 2022