An interventional study of RF Non-Invasive Treatment in Hair Removal, Pseudo Folliculitis Barbae and Benign Vascular Lesion, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Cynosure, Inc. (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Treatment
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.
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.
Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.
First submitted before Cynosure, Inc. became part of Cynosure Lutronic, Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 60 day (+/- 30 days) post last treatment
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.
Time frame: 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.
Time frame: 60 day (+/- 30 days) post last treatment
| Milestone | Elite IQ Laser |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| % of photos correctly identified | Elite IQ Laser |
|---|---|
| Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up. | 94.2 ± .05 |
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.
| Participants | Elite IQ Laser |
|---|---|
| Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS) | 20 |
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.
| Participants | Elite IQ Laser |
|---|---|
| Subject Satisfaction | 20 |
Collected over All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Elite IQ Laser | 0/20 (0%) | 0/20 (0%) | 20/20 (100%) |
| Event | Elite IQ Laser |
|---|---|
| EdemaSkin and subcutaneous tissue disorders | 20/20 |
| ErythemaSkin and subcutaneous tissue disorders | 20/20 |
| CrustingSkin and subcutaneous tissue disorders | 4/20 |
| BlisteringSkin and subcutaneous tissue disorders | 2/20 |
| HyperpigmentationSkin and subcutaneous tissue disorders | 1/20 |
| HypopigmentationSkin and subcutaneous tissue disorders | 1/20 |
| Age, Categorical(Participants) | Elite IQ Laser |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Elite IQ Laser |
|---|---|
| Female | 17 |
| Male | 3 |
| Race/Ethnicity, Customized(Participants) | Elite IQ Laser |
|---|---|
| Caucasian | 14 |
| Hispanic | 3 |
| Asian | 2 |
| African American | 1 |
| FitzPatrick Skin Type(Participants) | Elite IQ Laser |
|---|---|
| Fitzpatrick Skin Type I | 0 |
| Fitzpatrick Skin Type II | 7 |
| Fitzpatrick Skin Type III | 8 |
| Fitzpatrick Skin Type IV | 2 |
| Fitzpatrick Skin Type V | 2 |
| Fitzpatrick Skin Type VI | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2021 to primary completion in Mar 2022, 11 months.
Results were first posted in Jun 2023, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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