Post Market Study Using The Elite IQ Device

NCT04807205 | Completed Results FDA Device

• 1 other identifier: CYN20-ELITEIQ-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Removal; Pseudo Folliculitis Barbae; Benign Vascular Lesion; Pigmented Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS)

  60 day (+/- 30 days) post last treatment

• Subject Satisfaction

  60 day (+/- 30 days) post last treatment

Study Arms (1)

Elite IQ Laser

EXPERIMENTAL

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

Interventions

RF Non-Invasive Treatment DEVICE

Self-controlled single-arm group using the Elite IQ device

Elite IQ Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Scripps Clinic Carmel Valley

San Diego, California, 92130, United States

Location

Related Publications (1)

• 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.

  PMID: 31896400 RESULT

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

(978) 256-4200

Study Officials

• Jennifer Civiok

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 19, 2021
• Study Start: March 26, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: June 12, 2024
• Results First Posted: June 15, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)