Cutaneous Effects of Cryogen Spray Cooling

Phase 1

Completed

• Conditions: Pain
• Interventions: Other: Cutaneous Effects of Cryogen Spray Cooling

• Registration Number: NCT00581568
• Lead Sponsor: University of California, Irvine

Brief 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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Adult 18 years and older

Exclusion Criteria

• Age <18
• History of cold sensitivity
• Inflammatory rash on the test site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Effects of Cryogen Spray Cooling	Cutaneous Effects of Cryogen Spray Cooling	Cutaneous Effects of Cryogen Spray Cooling

Primary Outcome Measures

Name	Time	Method
Skin cooling during laser treatment	1 minute	Cryogen Spray Cooling spray cooling skin during laser treatment

Trial Locations

Locations (1)

Beckman Laser Institute Medical and Surgical clinic; 🇺🇸 Irvine, California, United States