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OpenTrials
Completed

NCT Number: NCT00581568

Cutaneous Effects of Cryogen Spray Cooling

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beckman Laser Institute Medical and Surgical clinic

Irvine, California, 92612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult 18 years and older

Exclusion criteria

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

Treatment and study plan

Cutaneous Effects of Cryogen Spray Cooling

Other

Cutaneous Effects of Cryogen Spray Cooling

Other names: CSC

Primary outcomes

  1. Skin cooling during laser treatment

    Time frame: 1 minute

    Cryogen Spray Cooling spray cooling skin during laser treatment

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Beckman Laser Institute University of California Irvine

Registry information

Acronym: CSC

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Dec 27, 2007
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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