Clinical Trials Directory

Trials / Completed

CompletedNCT00581568

Cutaneous Effects of Cryogen Spray Cooling

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
53 (actual)
Sponsor
University of California, Irvine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERCutaneous Effects of Cryogen Spray CoolingCutaneous Effects of Cryogen Spray Cooling

Timeline

Start date
2004-01-01
Primary completion
2010-09-01
Completion
2010-09-01
First posted
2007-12-27
Last updated
2022-11-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00581568. Inclusion in this directory is not an endorsement.