Hair RemovalNCT04807205
Post Market Study Using The Elite IQ Device
A study testing RF Non-Invasive Treatment in people with Hair Removal and Pseudo Folliculitis Barbae, run by Cynosure, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hair Removal, Pseudo Folliculitis Barbae, Benign Vascular Lesion
- What is being tested?
- RF Non-Invasive Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 2 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Clinic Carmel Valley
San Diego, California, 92130
About this study
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.
Read the 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.
- Being tested
- RF Non-Invasive Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF Non-Invasive TreatmentDevice
Self-controlled single-arm group using the Elite IQ device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RF Non-Invasive Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 day (+/- 30 days) post last treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 60 day (+/- 30 days) post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start26 Mar 2021
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hair RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Civiok, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807205
- Sponsor's protocol ID
- CYN20-ELITEIQ-02
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2021
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 31896400
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Study Using The Elite IQ Device
- ClinicalTrials.gov ID
- NCT04807205
- Acronym / sponsor ID
- CYN20-ELITEIQ-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elite IQ Laser | Experimental | Device: RF Non-Invasive TreatmentThe Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF Non-Invasive TreatmentSelf-controlled single-arm group using the Elite IQ device | Device | Elite IQ Laser |
Primary outcome
Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up.
Time frame: 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.
2 secondary outcomes
Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS)
Time frame: 60 day (+/- 30 days) post last treatment
Subject Satisfaction
Time frame: 60 day (+/- 30 days) post last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31896400Gupta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Civiok study director
Cynosure, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF Non-Invasive Treatment in people with Hair Removal and Pseudo Folliculitis Barbae, run by Cynosure, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up. (time frame: 60 day (+/- 30 days) post last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04807205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.