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Post Market Study Using The Elite IQ Device

Primary Purpose

Hair Removal, Pseudo Folliculitis Barbae, Benign Vascular Lesion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RF Non-Invasive Treatment
Sponsored by
Cynosure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hair Removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Clinic Carmel Valley

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elite IQ Laser

Arm Description

The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 11, 2021
Last Updated
May 22, 2023
Sponsor
Cynosure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04807205
Brief Title
Post Market Study Using The Elite IQ Device
Official Title
Post Market Study Using The Elite IQ Device
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Removal, Pseudo Folliculitis Barbae, Benign Vascular Lesion, Pigmented Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elite IQ Laser
Arm Type
Experimental
Arm Description
The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
Intervention Type
Device
Intervention Name(s)
RF Non-Invasive Treatment
Intervention Description
Self-controlled single-arm group using the Elite IQ device
Primary Outcome Measure Information:
Title
Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up.
Description
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.
Time Frame
60 day (+/- 30 days) post last treatment
Secondary Outcome Measure Information:
Title
Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS)
Description
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.
Time Frame
60 day (+/- 30 days) post last treatment
Title
Subject Satisfaction
Description
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.
Time Frame
60 day (+/- 30 days) post last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Civiok
Organizational Affiliation
Cynosure, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Clinic Carmel Valley
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31896400
Citation
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.
Results Reference
result

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Post Market Study Using The Elite IQ Device

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