Evaluation of a New Dermal Cryotherapy System

September 11, 2018 updated by: R2 Dermatology
A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 65819
        • Center of Dermatology and Laser Surgery
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Florida
      • Miami, Florida, United States, 33133
        • Bowes Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin pigmentation changes
Time Frame: 90 days
Changes in pigmentation graded using a 7-point standardized scale
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R2 Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2015

Primary Completion (Actual)

March 20, 2018

Study Completion (Actual)

June 12, 2018

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • R2-15-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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