Dermal Cooling System for Cryotherapy of Common Skin Conditions

R2 Dermatology

Status: Completed

Conditions: Skin Lesion

Treatments: Device: Dermal Cooling System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03282994

R2-17-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Treatment with cryotherapy

Experimental group

Description:

Dermal Cooling System

Treatment:

Device: Dermal Cooling System