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

Skin Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270512
• Other study ID #: R2-21-001
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: R2 Dermatology
• Contact: Dennell A Vargas
• Phone: 5104152038
• Email: dvargas[@]r2technologies.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

2. Subject has a skin condition amenable to cryosurgical treatment including, for example, 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 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 area for the duration of the 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 during the study.

Exclusion Criteria:

1. 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

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 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.

Related Conditions & MeSH terms

• Skin Diseases
• Skin Lesion

Intervention

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

Locations

Country	Name	City	State
United States	Dermatology, Laser and Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	West Coast Research	Dublin	California
United States	Oak Dermatology	Naperville	Illinois
United States	Skin Search of Rochester, Inc.	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
R2 Dermatology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 3 months
Primary	Incidence of treatment-emergent adverse events	The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.	Up to 12 months