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OpenTrials
Completed

NCT Number: NCT04599751

The Trio Laser Module for Hair Removal Treatment

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skin Care Research, LLC, Hollywood, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hair removal treatment

Device

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

Primary outcomes

  1. Change in hair count

    Time frame: 3 month after the last treatment

    Change in hair count, preformed by blinded evaluators, based on photographs taken at 3m FU visit compared to baseline

  2. Safety- Adverse events

    Time frame: Through study completion, an average of 1 year

    Adverse events and serious AE reported at any time during the trial or follow-up

Secondary outcomes

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

    Time frame: up to 24 weeks

    The investigator will assess the treatment area and score treatment related side effects using a 5-point likert scale, before and after the treatment

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

    Time frame: up to 24 weeks

    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

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

    Time frame: up to 24 weeks

    Subjects will be requested to scale their treatment related pain

  4. Subject's satisfaction from the treatment, using a 5-point Likert scale (when "1" indicates very dissatisfied and "5" very satisfied)

    Time frame: 3 months after the last treatment

    Subjects will be requested to scale their satisfaction from the treatment

Sponsors and collaborators

Lead sponsor

Alma Lasers

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.