Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2020-10-07
2021-11-16
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hair removal treatment
Trio laser module (Alma Lasers)
Hair removal treatment
Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).
Interventions
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Hair removal treatment
Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Alma Lasers
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Gold, MD
Role: PRINCIPAL_INVESTIGATOR
Tennessee Clinical Research Center
Edwardo Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Skin Care Research, LLC
Locations
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Skin Care Research, LLC
Hollywood, Florida, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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ALM-Trio-20-001
Identifier Type: -
Identifier Source: org_study_id