Unwanted Fine Facial HairNCT04975243
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro™/GentleMax Pro Plus™
A study testing GentleMax Pro Plus 755nm and 1064nm laser system in people with Unwanted Fine Facial Hair, run by Candela Corporation at 1 site in United States.
Trial summary
This clinical study is intended to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal while using short pulse durations to improve the efficacy of achieving permanent reduction of fine facial hairs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unwanted Fine Facial Hair
- What is being tested?
- GentleMax Pro Plus 755nm and 1064nm laser system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 30 Sep 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age or older
- Willingness to provide signed, informed consent to participate in the study
- Presence of unwanted hair of desired characteristics and treatment location to be evaluated in this study
- Willingness to adhere to study treatment and follow-up schedule
- Willingness to adhere to post-treatment care instructions
- Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
- Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study
Who cannot join
- Pregnant, planning pregnancy during the study, or breast feeding
- Blonde, grey, or white hair in subjects seeking hair removal
- Tattooed skin in the intended treatment area
- Active suntan in the intended treatment area
- History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
- History of melanoma
Show all 14Show fewer
- History of vitiligo in the intended treatment area
- History of keloid or hypertrophic scar formation
- History of Melasma in the intended treatment area or per Investigator's discretion
- Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment
- Open wound or infection in the intended treatment area
- History of light induced seizure disorders
- The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety
- Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Candela Institute of Excellence
Marlborough, Massachusetts, 01752
About this study
This clinical study is intended to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal while using short pulse durations to improve the efficacy of achieving permanent reduction of fine facial hairs.
Read the detailed description
Prospective, non-randomized, open label trial to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal with variable pulse durations and spot sizes.
Up to 30 subjects may be enrolled in this study at one (1) investigational site. Subjects having difficult to treat unwanted fine facial hairs having Fitzpatrick skin type (FST) I to VI are eligible for this study.
In order to have a diverse sample of study subjects, the following criteria was established to ensure a wide array of skin types and race and ethnicities for data analysis. At least 15 subjects must have FST III to V. The remaining subjects can include other FST, but must still have fine facial hairs where permanent hair reduction is difficult to achieve with 3 ms pulses.
Participants will receive four (4) laser hair removal treatment visits (with maximum interval of 10 weeks in between treatment visits) depending on the treatment area and three (3) follow up visits (1 month, 3 month, and 6 month after final treatment).
- Conditions
- Unwanted Fine Facial Hair
- Being tested
- GentleMax Pro Plus 755nm and 1064nm laser system
- Keywords
- Laser Hair Removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleMax Pro Plus 755nm and 1064nm laser systemDevice
The GentleMax Pro Plus is a 755nm and 1064nm laser system. The GentleMax Pro PlusTM is indicated for stable long-term or permanent hair reduction using varying spot sizes and fluences.
| Study group | Role | What they receive |
|---|---|---|
| Unwanted Fine Facial Hair | Experimental | Up to three (3) treatments with GentleMax Pro/ GentleMax Pro Plus TM for Laser Hair Removal Receives: Device: GentleMax Pro Plus 755nm and 1064nm laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in hair removal/ hair clearance
Improvement in hair removal/ hair clearance quantified by hair counts taken within a portion of the treatment area
Measured: 12 Months
Incidence, severity, and relatedness of adverse events
Analysis of the incidence, severity, and relatedness of adverse events to study treatment.
Measured: 12 Months
Secondary outcomes (3)
Laser Hair Removal improvement
Overall level of improvement in laser hair removal as measured by Investigator using a 5-point Global Aesthetic Improvement Scale (IGAIS) (1= Very Much Improved, 5= Worse)
Measured: 12 Months
Subject satisfaction with treatment results
Overall subject satisfaction with study treatments as measured using a 5- point Subject Satisfaction Scale (1= Not Satisfied, 5= Very Satisfied)
Measured: 12 Months
Subject satisfaction with treatment results
Overall subject satisfaction with study treatments as measured using a 5- point Subject Global Aesthetic Improvement Scale (SGAIS) (1= Very Much Improved, 5= Worse)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start19 Mar 2021
- Primary completion30 Nov 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unwanted Fine Facial HairStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975243
- Sponsor's protocol ID
- GMP20001
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro™/GentleMax Pro Plus™
- ClinicalTrials.gov ID
- NCT04975243
- Acronym / sponsor ID
- GMP20001
- Conditions
- Unwanted Fine Facial Hair
- Keywords
- Laser Hair Removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 23 Jul 2021 (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.
This clinical study is intended to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal while using short pulse durations to improve the efficacy of achieving permanent reduction of fine facial hairs.
Detailed description
Prospective, non-randomized, open label trial to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal with variable pulse durations and spot sizes.
Up to 30 subjects may be enrolled in this study at one (1) investigational site. Subjects having difficult to treat unwanted fine facial hairs having Fitzpatrick skin type (FST) I to VI are eligible for this study.
In order to have a diverse sample of study subjects, the following criteria was established to ensure a wide array of skin types and race and ethnicities for data analysis. At least 15 subjects must have FST III to V. The remaining subjects can include other FST, but must still have fine facial hairs where permanent hair reduction is difficult to achieve with 3 ms pulses.
Participants will receive four (4) laser hair removal treatment visits (with maximum interval of 10 weeks in between treatment visits) depending on the treatment area and three (3) follow up visits (1 month, 3 month, and 6 month after final treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unwanted Fine Facial Hair | Experimental | Device: GentleMax Pro Plus 755nm and 1064nm laser systemUp to three (3) treatments with GentleMax Pro/ GentleMax Pro Plus TM for Laser Hair Removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age or older
- Willingness to provide signed, informed consent to participate in the study
- Presence of unwanted hair of desired characteristics and treatment location to be evaluated in this study
- Willingness to adhere to study treatment and follow-up schedule
- Willingness to adhere to post-treatment care instructions
Key exclusion criteria (14 listed)
- Pregnant, planning pregnancy during the study, or breast feeding
- Blonde, grey, or white hair in subjects seeking hair removal
- Tattooed skin in the intended treatment area
- Active suntan in the intended treatment area
- History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
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 |
|---|---|---|
| GentleMax Pro Plus 755nm and 1064nm laser systemThe GentleMax Pro Plus is a 755nm and 1064nm laser system. The GentleMax Pro PlusTM is indicated for stable long-term or permanent hair reduction using varying spot sizes and fluences. | Device | Unwanted Fine Facial Hair |
Primary outcome
Improvement in hair removal/ hair clearance
Time frame: 12 Months
Improvement in hair removal/ hair clearance quantified by hair counts taken within a portion of the treatment area
Incidence, severity, and relatedness of adverse events
Time frame: 12 Months
Analysis of the incidence, severity, and relatedness of adverse events to study treatment.
3 secondary outcomes
Laser Hair Removal improvement
Time frame: 12 Months
Subject satisfaction with treatment results
Time frame: 12 Months
Subject satisfaction with treatment results
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleMax Pro Plus 755nm and 1064nm laser system in people with Unwanted Fine Facial Hair, run by Candela Corporation at 1 site 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Improvement in hair removal/ hair clearance (time frame: 12 Months). 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 9 Feb 2023.