Back to resultsClinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
Primary Purpose
Pseudofolliculitis Barbae, Unwanted Hair, Pigmented Lesions
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GentleMax Pro Plus
Sponsored by
About this trial
This is an interventional treatment trial for Pseudofolliculitis Barbae
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age or older
- Willingness to provide signed, informed consent to participate in the study
- Presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1
- 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
Exclusion Criteria:
- 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 sun tan 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
- 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
Sites / Locations
- Candela Institute of Excellence
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
All study subjects are to receive treatment with GentleMax Pro Plus device. Subjects will be scheduled to receive as little as one (1) and up to eight (8) treatments with the GentleMax Pro Plus™ Laser System. Up to 2 follow-ups will occur.
Outcomes
Primary Outcome Measures
Treatment Time
Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal
Hair Count Assessments
Improvement in hair clearance quantified by hair counts taken within a portion of the treatment area and percent reduction by assessments of digital photos taken at Baseline compared to follow-ups.
Global Aesthetic Improvement Score
Improvement in the appearance of wrinkles, benign pigmented lesions, and/or vascular lesions from baseline to follow-up(s) via the Investigator Global Aesthetic Improvement Score (IGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Fitzpatrick Wrinkle and Elastosis Score
Improvement in the appearance of wrinkles from baseline to follow-up(s) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale whereas 1 = fine wrinkles and mild elastosis and 9 = deep wrinkles and severe elastosis. A lower score post treatment(s) indicates a better outcome.
Pigment Improvement Score
Improvement in BPLs from baseline to follow-ups via the Investigator Pigment Improvement Score (PIS) whereas 0 = no improvement and 4 = excellent response. A higher score post treatment(s) indicates a better outcome.
Acne Counts
Measured by improvement of acne counts from baseline compared to follow-ups. A lower score post treatment(s) indicates a better outcome.
Onychomycosis Score
Improvement in the appearance of nails from Baseline to follow-up(s) via the Scoring Clinical Index of Onychomycosis (SCIO Index) which ranges from 0 to 30 whereas 0 indicates lesser degree of onychomycosis and 30 indicates higher degree of onychomycosis. A lower score post treatment(s) indicates a better outcome.
Onychomycosis Score
Improvement in the appearance of nails from Baseline to follow-up(s) via the Onychomycosis Improvement Scale whereas 1 = completely cleared and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Secondary Outcome Measures
Subject Satisfaction Score
Overall subject satisfaction with study treatments per treatment indication as measured by Subject Satisfaction Scale whereas 1 = not satisfied and 5 = very satisfied. A higher score post treatment(s) indicates a better outcome.
Subject Global Aesthetic Improvement Score
Overall subject improvement with study treatments per treatment indication as measured by Subject Global Aesthetic Improvement Score (SGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Subject Pain
Measurement of Subject Pain Assessment post-treatment for all subjects, using an 11-point pain Numerical Rating Scale where 0=no pain, 10=extreme pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04993066
Brief Title
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
Official Title
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
April 22, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Candela Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of acne.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudofolliculitis Barbae, Unwanted Hair, Pigmented Lesions, Vascular Lesion, Onychomycosis, Wrinkle, Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
All study subjects are to receive treatment with GentleMax Pro Plus device. Subjects will be scheduled to receive as little as one (1) and up to eight (8) treatments with the GentleMax Pro Plus™ Laser System. Up to 2 follow-ups will occur.
Intervention Type
Device
Intervention Name(s)
GentleMax Pro Plus
Intervention Description
The GentleMax Pro Plus laser system to be used in this study received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) under K201111 on May 26, 2020
Primary Outcome Measure Information:
Title
Treatment Time
Description
Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal
Time Frame
8 Months
Title
Hair Count Assessments
Description
Improvement in hair clearance quantified by hair counts taken within a portion of the treatment area and percent reduction by assessments of digital photos taken at Baseline compared to follow-ups.
Time Frame
14 Months
Title
Global Aesthetic Improvement Score
Description
Improvement in the appearance of wrinkles, benign pigmented lesions, and/or vascular lesions from baseline to follow-up(s) via the Investigator Global Aesthetic Improvement Score (IGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Time Frame
7 Months
Title
Fitzpatrick Wrinkle and Elastosis Score
Description
Improvement in the appearance of wrinkles from baseline to follow-up(s) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale whereas 1 = fine wrinkles and mild elastosis and 9 = deep wrinkles and severe elastosis. A lower score post treatment(s) indicates a better outcome.
Time Frame
7 Months
Title
Pigment Improvement Score
Description
Improvement in BPLs from baseline to follow-ups via the Investigator Pigment Improvement Score (PIS) whereas 0 = no improvement and 4 = excellent response. A higher score post treatment(s) indicates a better outcome.
Time Frame
7 Months
Title
Acne Counts
Description
Measured by improvement of acne counts from baseline compared to follow-ups. A lower score post treatment(s) indicates a better outcome.
Time Frame
5 Months
Title
Onychomycosis Score
Description
Improvement in the appearance of nails from Baseline to follow-up(s) via the Scoring Clinical Index of Onychomycosis (SCIO Index) which ranges from 0 to 30 whereas 0 indicates lesser degree of onychomycosis and 30 indicates higher degree of onychomycosis. A lower score post treatment(s) indicates a better outcome.
Time Frame
9 Months
Title
Onychomycosis Score
Description
Improvement in the appearance of nails from Baseline to follow-up(s) via the Onychomycosis Improvement Scale whereas 1 = completely cleared and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Subject Satisfaction Score
Description
Overall subject satisfaction with study treatments per treatment indication as measured by Subject Satisfaction Scale whereas 1 = not satisfied and 5 = very satisfied. A higher score post treatment(s) indicates a better outcome.
Time Frame
24 Months
Title
Subject Global Aesthetic Improvement Score
Description
Overall subject improvement with study treatments per treatment indication as measured by Subject Global Aesthetic Improvement Score (SGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Time Frame
24 Months
Title
Subject Pain
Description
Measurement of Subject Pain Assessment post-treatment for all subjects, using an 11-point pain Numerical Rating Scale where 0=no pain, 10=extreme pain
Time Frame
8 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age or older
Willingness to provide signed, informed consent to participate in the study
Presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1
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
Exclusion Criteria:
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 sun tan 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
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
Facility Information:
Facility Name
Candela Institute of Excellence
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
N/A, no plan to share IPD
Learn more about this trial
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
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