Dermal Cooling System for Cryotherapy of Common Skin Conditions

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

Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.

Study Overview

• Status: Completed
• Conditions: Skin Lesion
• Intervention / Treatment: Device: Dermal Cooling System

Detailed Description

The purpose of this study is to establish that controlled localized cooling with the Dermal Cooling System will elicit an improvement in the cosmetic appearance of benign superficial lesions associated with common skin conditions that are currently being treated with cryosurgical methods.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Clear Dermatology & Aesthetics Center
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin and Laser Specialists
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser and Vein Specialists of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female subjects > 18 years of age.
2. Subject has benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.
3. Subject is willing to have up to 40 test sites treated.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).
2. Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject.
3. History of melanoma.
4. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
5. History of abnormal wound healing or abnormal scarring
6. Inability or unwillingness to comply with the study requirements.
7. Subject is pregnant or planning to become pregnant while enrolled in the study.
8. Subject is lactating.
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 increased or unacceptable risk to the subject.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with cryotherapy; Dermal Cooling System	Device: Dermal Cooling System; Cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in appearance in the treatment area	Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of procedure related adverse events	• Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events	less than 12 months

Collaborators and Investigators

• Sponsor: R2 Dermatology
• Investigators: Study Director: Kristine Tatsutani, PhD, R2 Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): November 17, 2018
• Study Completion (Actual): November 17, 2018

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: R2-17-003

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
• Studies a U.S. FDA-regulated device product: Yes