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

NCT04993066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-11-14

No results posted yet for this study

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.

Conditions

  • Pseudofolliculitis Barbae
  • Unwanted Hair
  • Pigmented Lesions
  • Vascular Lesion
  • Onychomycosis
  • Wrinkle
  • Acne

Interventions

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

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
2020-11-12
Primary Completion
2022-05-31
Completion
2023-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04993066 on ClinicalTrials.gov