Post Market Study Using The Elite IQ Device

Not Applicable

Completed

Conditions: Benign Vascular Lesion
Hair Removal
Pseudo Folliculitis Barbae
Pigmented Lesions

Interventions: Device: RF Non-Invasive Treatment

Registration Number: NCT04807205

Lead Sponsor: Cynosure, Inc.

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elite IQ Laser	RF Non-Invasive Treatment	The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.

Primary Outcome Measures

Name	Time	Method
Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up.	60 day (+/- 30 days) post last treatment	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.

Secondary Outcome Measures

Name	Time	Method
Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS)	60 day (+/- 30 days) post last treatment	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.
Subject Satisfaction	60 day (+/- 30 days) post last treatment	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.