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

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

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis; Acne; Wrinkle; Pigmented Lesions; Pseudofolliculitis Barbae; Unwanted Hair; Vascular Lesion
• Intervention / Treatment: Device: GentleMax Pro Plus

• Study Type: Interventional
• Enrollment (Actual): 77
• 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

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, 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
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 sun tan 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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.	Device: GentleMax Pro Plus; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Time	Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal	8 Months
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.	14 Months
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.	7 Months
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.	7 Months
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.	7 Months
Acne Counts	Measured by improvement of acne counts from baseline compared to follow-ups. A lower score post treatment(s) indicates a better outcome.	5 Months
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.	9 Months
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.	9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 Months
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.	24 Months
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	8 Months

Collaborators and Investigators

• Sponsor: Candela Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: GMP19002, phase II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: N/A, no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes