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

R2 Dermatology

Status

Enrolling

Conditions

Skin Lesion

Treatments

Device: Dermal Cooling System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05270512

R2-21-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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.