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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05270512
Other study ID # R2-21-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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