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 Safety and Efficacy of Trio Diode Laser Module for Hair Removal Treatment in All Skin Types
Sponsor study identifier
interventional
37
1 country
2
Study Start
October 7, 2020
Actual (reported)Primary Completion
October 7, 2021
Actual (reported)Study Completion
November 16, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 16, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2020
Actual (reported)October 11, 2020
Actual (reported)October 23, 2020
Actual (reported)October 7, 2021
Actual (reported)November 16, 2021
Actual (reported)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
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
Trio laser module (Alma Lasers)
Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Skin Care Research, LLC
Hollywood, Florida, 33021, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Michael Gold, MD
Tennessee Clinical Research Center
Edwardo Weiss, MD
Skin Care Research, LLC
37 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2020
First Posted
October 23, 2020
Study Start
October 7, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 7, 2021
Actual (reported)Study Completion
November 16, 2021
Actual (reported)Last Updated
November 17, 2021
Record last verified: 2021-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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