Benign Vascular Lesion, Hair Removal, Pigmented Lesions, Pseudo Folliculitis Barbae
Conditions
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.
Interventions
Self-controlled single-arm group using the Elite IQ device
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS) | 60 day (+/- 30 days) post last treatment | 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 | 60 day (+/- 30 days) post last treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Elite IQ Laser The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Elite IQ Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type I | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type II | 7 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type III | 8 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type IV | 2 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type V | 2 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type VI | 1 Participants |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
Population: Three subjects had an extra treatment area treated, and were graded for each separate treatment area, so the total number of treatment areas graded was 23 (23 photos were analyzed). Each photo was graded by 3 individual graders, for a total of 69 photos being analyzed. The average percentage of photographs identified correctly of these 3 graders is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 % of photos correctly identified | Standard Deviation 0.05 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elite IQ Laser | Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS) | 20 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elite IQ Laser | Subject Satisfaction | 20 Participants |