NCT00581568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1 pain

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

6.7 years

First QC Date

December 19, 2007

Last Update Submit

October 28, 2022

Conditions

Pain

Keywords

Skin cooling during laser treatment

Outcome Measures

Primary Outcomes (1)

  • Skin cooling during laser treatment

    Cryogen Spray Cooling spray cooling skin during laser treatment

    1 minute

Study Arms (1)

Effects of Cryogen Spray Cooling

EXPERIMENTAL

Cutaneous Effects of Cryogen Spray Cooling

Other: Cutaneous Effects of Cryogen Spray Cooling

Interventions

Cutaneous Effects of Cryogen Spray CoolingOTHER

Cutaneous Effects of Cryogen Spray Cooling

Also known as: CSC
Effects of Cryogen Spray Cooling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult 18 years and older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical and Surgical clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John S Nelson, M.D.,Ph.D

    Beckman Laser Institute

    STUDY CHAIR

  • Wangcun Jia, PhD

    Beckman Laser Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wangcun Jia, PhD., Research Scientist

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 27, 2007

Study Start

January 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)