Hair Removal TreatmentNCT04599751
The Trio Laser Module for Hair Removal Treatment
A study testing Hair removal treatment in people with Hair Removal Treatment, run by Alma Lasers at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Removal Treatment
- What is being tested?
- Hair removal treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2020to 16 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Skin Care Research, LLC
Hollywood, Florida, 33021
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
Official title: 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.
- Conditions
- Hair Removal Treatment
- Being tested
- Hair removal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair removal treatmentDevice
Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).
| Study group | Role | What they receive |
|---|---|---|
| Hair removal treatment | Experimental | Trio laser module (Alma Lasers) Receives: Device: Hair removal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hair count
Change in hair count, preformed by blinded evaluators, based on photographs taken at 3m FU visit compared to baseline
Measured: 3 month after the last treatment
Safety- Adverse events
Adverse events and serious AE reported at any time during the trial or follow-up
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start7 Oct 2020
- Primary completion7 Oct 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair Removal TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Gold, MD, Principal investigator, Tennessee Clinical Research CenterEdwardo Weiss, MD, Principal investigator, Skin Care Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599751
- Sponsor's protocol ID
- ALM-Trio-20-001
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2020
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Trio Diode Laser Module for Hair Removal Treatment in All Skin Types
- ClinicalTrials.gov ID
- NCT04599751
- Acronym / sponsor ID
- ALM-Trio-20-001
- Conditions
- Hair Removal Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Alma LasersIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hair removal treatment | Experimental | Device: Hair removal treatmentTrio laser module (Alma Lasers) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair removal treatmentAxilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers). | Device | Hair removal treatment |
Primary outcome
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
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
4 secondary outcomes
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
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
Subject treatment related pain assessment, using VAS ( when "0" indicates "no pain" and "10" " worst possible pain"
Time frame: 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)
Time frame: 3 months after the last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gold, MD principal investigator
Tennessee Clinical Research Center
Edwardo Weiss, MD principal investigator
Skin Care Research, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair removal treatment in people with Hair Removal Treatment, run by Alma Lasers at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hair count (time frame: 3 month after the last treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.