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Evaluation of a New Dermal Cryotherapy System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02744794
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
R2 Dermatology

Brief Summary:
A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.

Condition or disease Intervention/treatment Phase
Skin Lightening Device: Dermal Cooling System Not Applicable

Detailed Description:
This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a New Dermal Cryotherapy System
Actual Study Start Date : April 27, 2015
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : June 12, 2018

Arm Intervention/treatment
Experimental: Treatment with cryotherapy
Treatment with dermal cooling system.
Device: Dermal Cooling System
Treatment with cryotherapy.




Primary Outcome Measures :
  1. Skin pigmentation changes [ Time Frame: 90 days ]
    Changes in pigmentation graded using a 7-point standardized scale


Secondary Outcome Measures :
  1. Evaluation of device- or procedure-related adverse events [ Time Frame: 0 to 12 months ]
    Side effects, discomfort assessments both during treatment and follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects > 18 years of age.
  2. Subject is willing to have up to 40 test sites treated on aesthetically discreet skin.
  3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
  4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

  1. Fitzpatrick skin type VI.
  2. Physician prescribed, medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
  3. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
  4. Dermatological conditions or scars in the location of the treatment sites
  5. History of melanoma, personal or first degree relative
  6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
  7. History of abnormal wound healing or abnormal scarring
  8. Inability or unwillingness to comply with study requirments.
  9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
  10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744794


Locations
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United States, California
Center of Dermatology and Laser Surgery
Sacramento, California, United States, 65819
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Florida
Bowes Dermatology
Miami, Florida, United States, 33133
Sponsors and Collaborators
R2 Dermatology
Investigators
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Study Director: Kristine Tatsutani, PhD R2 Dermatology, Inc.
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Responsible Party: R2 Dermatology
ClinicalTrials.gov Identifier: NCT02744794    
Other Study ID Numbers: R2-15-001
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No