Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro™/GentleMax Pro Plus™

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Unwanted Fine Facial Hair
• Intervention / Treatment: Device: GentleMax Pro Plus 755nm and 1064nm laser system

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Marlborough, Massachusetts, United States, 01752
      • Candela Institute of Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. At least 18 years of age or older
2. Willingness to provide signed, informed consent to participate in the study
3. Presence of unwanted hair of desired characteristics and treatment location to be evaluated in this study
4. Willingness to adhere to study treatment and follow-up schedule
5. Willingness to adhere to post-treatment care instructions
6. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
7. 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:

1. Pregnant, planning pregnancy during the study, or breast feeding
2. Blonde, grey, or white hair in subjects seeking hair removal
3. Tattooed skin in the intended treatment area
4. Active suntan in the intended treatment area
5. History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
6. History of melanoma
7. History of vitiligo in the intended treatment area
8. History of keloid or hypertrophic scar formation
9. History of Melasma in the intended treatment area or per Investigator's discretion
10. Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment
11. Open wound or infection in the intended treatment area
12. History of light induced seizure disorders
13. 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
14. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Unwanted Fine Facial Hair; Up to three (3) treatments with GentleMax Pro/ GentleMax Pro Plus TM for Laser Hair Removal	Device: GentleMax Pro Plus 755nm and 1064nm laser system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in hair removal/ hair clearance	Improvement in hair removal/ hair clearance quantified by hair counts taken within a portion of the treatment area	12 Months
Incidence, severity, and relatedness of adverse events	Analysis of the incidence, severity, and relatedness of adverse events to study treatment.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Pain Assessment	Measurement of Subject Pain Assessment post-treatment for all subjects, using an 11-point Numerical Rating Scale (0=no pain, 10=extreme pain)	6 months

Collaborators and Investigators

• Sponsor: Candela Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2021
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Laser Hair Removal
• Other Study ID Numbers: GMP20001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No