- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581568
Cutaneous Effects of Cryogen Spray Cooling (CSC)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Irvine, California, United States, 92612
- Beckman Laser Institute Medical and Surgical Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult 18 years and older
Exclusion Criteria:
- Age <18
- History of cold sensitivity
- Inflammatory rash on the test site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Effects of Cryogen Spray Cooling
Cutaneous Effects of Cryogen Spray Cooling
|
Cutaneous Effects of Cryogen Spray Cooling
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin cooling during laser treatment
Time Frame: 1 minute
|
Cryogen Spray Cooling spray cooling skin during laser treatment
|
1 minute
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: John S Nelson, M.D.,Ph.D, Beckman Laser Institute
- Principal Investigator: Wangcun Jia, PhD, Beckman Laser Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20033200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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