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

Primary Purpose

Skin Lesion

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dermal Cooling System

About this trial

This is an interventional treatment trial for Skin Lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female subjects > 18 years of age.
Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
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 area for the duration of the study, including the follow-up period, if requested.
Subject has read and signed a written informed consent form.
Subject is willing to comply with adjuvant topical regimen, as applicable.
Subject agrees not to undergo any other procedure(s) in the treatment area during the study.

Exclusion Criteria:

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
Use of Accutane within the previous 6 months
History of melanoma
Subject is pregnant or intending to become pregnant during the study period
Subject is lactating or has been lactating in the past 6 months
Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
History of abnormal wound healing or abnormal scarring
Inability or unwillingness to comply with the study requirements.
Current enrollment in a clinical study of any other unapproved investigational drug or device.
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.

Sites / Locations

West Coast ResearchRecruiting
Oak DermatologyRecruiting
Skin Search of Rochester, Inc.Recruiting
Dermatology, Laser and Vein Specialists of the CarolinasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with Dermal Cooling System

Arm Description

Dermal Cooling System will be used in all eligible subjects.

Outcomes

Primary Outcome Measures

Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).

Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse).

Incidence of treatment-emergent adverse events

The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.

Secondary Outcome Measures

Full Information

NCT ID

NCT05270512

First Posted

February 25, 2022

Last Updated

August 28, 2023

Sponsor

R2 Dermatology

1. Study Identification

Unique Protocol Identification Number

NCT05270512

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 10, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

R2 Dermatology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Lesion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment with Dermal Cooling System

Arm Type

Experimental

Arm Description

Dermal Cooling System will be used in all eligible subjects.

Intervention Type

Device

Intervention Name(s)

Dermal Cooling System

Intervention Description

Controlled localized cooling may be applied to lesions using the Dermal Cooling System.

Primary Outcome Measure Information:

Title

Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).

Description

Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse).

Time Frame

up to 3 months

Title

Incidence of treatment-emergent adverse events

Description

The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects > 18 years of age. Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma. Subject is willing to have skin exposed to cooling with the Dermal Cooling System. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes. 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 area for the duration of the study, including the follow-up period, if requested. Subject has read and signed a written informed consent form. Subject is willing to comply with adjuvant topical regimen, as applicable. Subject agrees not to undergo any other procedure(s) in the treatment area during the study. Exclusion Criteria: 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 Use of Accutane within the previous 6 months History of melanoma Subject is pregnant or intending to become pregnant during the study period Subject is lactating or has been lactating in the past 6 months Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease. History of abnormal wound healing or abnormal scarring Inability or unwillingness to comply with the study requirements. Current enrollment in a clinical study of any other unapproved investigational drug or device. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dennell A Vargas

Phone

5104152038

dvargas@r2technologies.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristine Tatsutani, PhD

Organizational Affiliation

R2 Technologies

Official's Role

Study Director

Facility Information:

Facility Name

West Coast Research

City

Dublin

State/Province

California

ZIP/Postal Code

94568

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tim Davis

Phone

925-413-1451

tdavis@westcoastresearch.com

First Name & Middle Initial & Last Name & Degree

Alfred E Tan, MD

Facility Name

Oak Dermatology

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peri Todd, MS

Phone

630-931-0886

peri.todd@oakderm.com

First Name & Middle Initial & Last Name & Degree

Ashish C Bhatia, MD

Facility Name

Skin Search of Rochester, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denise Forster, BS

Phone

585-697-1818

dforster@dermrochester.com

First Name & Middle Initial & Last Name & Degree

Leslie Loss, MD

Facility Name

Dermatology, Laser and Vein Specialists of the Carolinas

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Razia Ludin, BSc

Phone

704-973-3687

RaziaL@carolinaskin.com

First Name & Middle Initial & Last Name & Degree

Girish Munavalli, MD

12. IPD Sharing Statement

Learn more about this trial

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

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