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

NCT ID: NCT04975243

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2023-09-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unwanted Fine Facial Hair

Up to three (3) treatments with GentleMax Pro/ GentleMax Pro Plus TM for Laser Hair Removal

Group Type: EXPERIMENTAL

GentleMax Pro Plus 755nm and 1064nm laser system

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Candela Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Candela Institute of Excellence

Marlborough, Massachusetts, United States

Countries

United States

Other Identifiers

GMP20001

Identifier Type: -

Identifier Source: org_study_id