Post Market Study Using The Elite IQ Device

This is a prospective, open label, single-center clinical study to collect safety and efficacy data on the Elite iQ workstation. The intended use of the Elite iQ device used in this study is for the treatment of hair removal, pseudo folliculitis barbae, and benign vascular and pigmented lesions.

Study Overview

• Status: Completed
• Conditions: Hair Removal; Pseudo Folliculitis Barbae; Benign Vascular Lesion; Pigmented Lesions
• Intervention / Treatment: Device: RF Non-Invasive Treatment

Detailed Description

Up to 20 subjects will be enrolled at up to 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments on multiple areas of the body such as, but not limited to, the face, legs, and arms. All subjects will be required to return a follow-up visit at 30 - 90 days after the final treatment in each treatment area.

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

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92130
      • Scripps Clinic Carmel Valley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A healthy male or female 18 years of age or older.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

• The subject is hypersensitive to light in the near infrared wavelength region
• The subject has sun-damaged skin (treatment contraindicated with Alex laser only)
• The subject had recent unprotected sun exposure (for Alex laser within four weeks of treatment; for Nd:YAG laser within one week of treatment), including the use of tanning beds or tanning products, such as creams, lotions and sprays
• The subject is taking medication which is known to increase sensitivity to sunlight
• The subject has seizure disorders triggered by light
• The subject is taking anticoagulants
• The subject is taking or have taken oral isotretinoin, such as Accutane®, within the last six months
• The subject is taking medication that alters the wound-healing response
• The subject has a history of healing problems or history of keloid formation
• The subject has an active localized or systemic infection, or an open wound in area being treated
• The subject has a significant systemic illness or an illness localized in area being treated
• The subject has a history of skin cancer or suspicious lesions
• The subject has an autoimmune disease
• The subject is receiving or have received gold therapy
• The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

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: Elite IQ Laser; The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.	Device: RF Non-Invasive Treatment; Self-controlled single-arm group using the Elite IQ device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up.	Blind identification of pre-treatment images vs. 60 day follow up images. It is performed by independent reviewers. The outcome will be reported as a percentage of photographs identified correctly.	60 day (+/- 30 days) post last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS)	Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 60 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." This is the count of the number of subjects who the physician graded a 3 or higher.	60 day (+/- 30 days) post last treatment
Subject Satisfaction	Subject satisfaction rates at the 60 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied. This is the count of the number of subjects who graded themselves a 4 or higher.	60 day (+/- 30 days) post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Jennifer Civiok, Cynosure, Inc.

Publications and helpful links

General Publications

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): March 2, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Folliculitis
• Other Study ID Numbers: CYN20-ELITEIQ-02

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.: Yes