Skin Lesion
Conditions
Brief summary
Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.
Detailed 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.
Interventions
DEVICEDermal Cooling System
Cryotherapy
Sponsors
R2 Dermatology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in appearance in the treatment area | 3-months | Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of procedure related adverse events | less than 12 months | • Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events |
Countries
United States
Outcome results
None listed