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. · 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.
Exclusion Criteria:
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 |
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Folliculitis
Cynosure, Inc.