Post Market Study Using The Elite IQ Device (NCT04807205) | Clinical Trial Compass
CompletedNot Applicable
Post Market Study Using The Elite IQ Device
United States20 participantsStarted 2021-03-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 suspi…
What they're measuring
1
Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up.
Timeframe: 60 day (+/- 30 days) post last treatment