Cutaneous Effects of Cryogen Spray Cooling (CSC)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Cryogen Spray Cooling spurt is applied to the skin surface immediately before laser exposure. As liquid cryogen rapidly evaporates, the superficial skin temperature is reduced as a result of supplying the latent heat of vaporization. Tetrafluoroethane, an environmentally compatible, non-toxic, non-flammable freon substitute, has been demonstrated in multiple studies to be a safe and effective cooling agent and is the only cryogenic compound currently approved for dermatologic use by the Food and Drug Administration.
Full description
The researcher can use laser treatment in combination with Cryogen Spray Cooling. The specific aim of this study is to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns that spurt durations of 100 ms or less will result in a very low incidence (less than 2%) of clinical skin effects (redness, blistering, local skin allergic reaction or skin discoloration) in any skin type.
Researchers can use Cryogen Spray Cooling to protect the skin epidermis during laser therapy to decrease treatment pain, allow safe treatment of darker skin types, and safe use of high laser fluences. Cryogen Spray Cooling with Tetrafluoroethane has been incorporated into many Food and Drug Administration approved, commercially available laser devices currently used for treatment of vascular lesions, hair removal and non-ablative skin rejuvenation.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult 18 years and older
Exclusion criteria
- Age <18
- History of cold sensitivity
- Inflammatory rash on the test site
Trial design
Primary purpose
Allocation
Interventional model
Masking
53 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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