Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro™/GentleMax Pro Plus™
NCT04975243 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-02-09
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.
Conditions
- Unwanted Fine Facial Hair
Interventions
- 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.
Sponsors & Collaborators
-
Candela Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-03-19
- Primary Completion
- 2022-11-30
- Completion
- 2023-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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