Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions

Last updated: November 19, 2024
Sponsor: R2 Dermatology
Overall Status: Completed

Phase

N/A

Condition

Skin Cancer

Pressure Ulcer

Treatment

Dermal Cooling System

Clinical Study ID

NCT05270512
R2-21-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects > 18 years of age.

  2. Subject has a skin condition amenable to cryosurgical treatment including, forexample, psoriasis, atopic dermatitis, acne, rosacea, and melasma.

  3. Subject is willing to have skin exposed to cooling with the Dermal Cooling System.

  4. Subject is willing to have digital photographs taken of the treatment area andagrees 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 usean approved sunscreen of SPF 50 or higher on the treated area for the duration ofthe study, including the follow-up period, if requested.

  6. Subject has read and signed a written informed consent form.

  7. Subject is willing to comply with adjuvant topical regimen, as applicable.

  8. Subject agrees not to undergo any other procedure(s) in the treatment area duringthe study.

Exclusion

Exclusion Criteria:

  1. Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous ormalignant lesions) in the location of the treatment sites that would, in theprofessional opinion of the investigator, potentially pose an increased risk to thesubject

  2. Use of Accutane within the previous 6 months

  3. History of melanoma

  4. Subject is pregnant or intending to become pregnant during the study period

  5. Subject is lactating or has been lactating in the past 6 months

  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 drugor device.

  10. Any other condition or laboratory value that would, in the professional opinion ofthe investigator, potentially affect response or participation in this clinicalstudy, or would pose an unacceptable risk to the subject.

Study Design

Total Participants: 88
Treatment Group(s): 1
Primary Treatment: Dermal Cooling System
Phase:
Study Start date:
December 10, 2021
Estimated Completion Date:
November 01, 2023

Study Description

This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.

Connect with a study center

  • West Coast Research

    Dublin, California 94568
    United States

    Site Not Available

  • Oak Dermatology

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Skin Search of Rochester, Inc.

    Rochester, New York 14623
    United States

    Site Not Available

  • Dermatology, Laser and Vein Specialists of the Carolinas

    Charlotte, North Carolina 28207
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.