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Dermal Cryotherapy for Treatment of Pigmented Lesions

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02848742
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : September 10, 2019
Information provided by (Responsible Party):
R2 Dermatology

Brief Summary:
Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions.

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

Detailed Description:
This study is a prospective, non-randomized, multi-center study of the Dermal Cooling System to verify that the device causes a reduction in pigmentation in benign pigmented lesions, and to determine at what parameters the device is most effective.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a New Dermal Cryotherapy System for the Treatment of Benign Pigmented Lesions
Study Start Date : June 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment with cryotherapy device
To include subjects with one or more benign pigmented lesions who are willing to have the pigmented skin exposed to cooling with the Dermal Cooling System.
Device: Dermal Cooling System
Dermal cryotherapy

Primary Outcome Measures :
  1. Reduction of pigmentation in treated lesions [ Time Frame: 90 days ]
    Changes in pigmentation graded using a 4-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

Inclusion Criteria:

  1. Male or female subjects > 18 years of age.
  2. Subject has one or more benign pigmented lesions (e.g., solar lentigines, melasma, freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment
  3. Subject is willing to have up to 40 treatment sites and/or an area up to 8 square inches treated depending on the size and nature of the lesions identified.
  4. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
  5. Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated areas for the duration of the study, including the follow-up period, if requested.
  6. Subject has read and signed a written informed consent form.

Exclusion Criteria:

  1. Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
  2. 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
  3. Scars or tattoos in the location of the treatment sites
  4. History of vitiligo, eczema, or psoriasis in the area of treatment
  5. History of melanoma
  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 the study requirements.
  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 identifier (NCT number): NCT02848742

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Contact: Kristine Tatsutani, PhD 1-844-372-3376
Contact: Dennell Vargas 925-378-4416

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United States, California
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Charlette Vargas    925-930-7267   
Principal Investigator: Leonard Chuck, MD, PhD         
Canada, British Columbia
Arbutus Laser Centre Recruiting
Vancouver, British Columbia, Canada, V6J 1Z6
Contact: Jen Wasilenchuk    604-731-5512   
Principal Investigator: Gerald Boey, MD         
Sponsors and Collaborators
R2 Dermatology
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Study Director: Kristine Tatsutani, PhD R2 Dermatology, Inc.

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Responsible Party: R2 Dermatology Identifier: NCT02848742     History of Changes
Other Study ID Numbers: R2-16-001
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Pathologic Processes