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
| Type | Name | Description |
|---|---|---|
| OTHER | Cutaneous Effects of Cryogen Spray Cooling | Cutaneous 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.