Skin Lesion
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEDermal Cooling System
Controlled localized cooling may be applied to lesions using the Dermal Cooling System.
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in appearance in the treated area as determined by the Physician Global Assessment (PGA). | up to 3 months | Investigator assessment using Physician Global Assessment (PGA); graded from 4 (very much improved) to 0 (worse). |
| Incidence of treatment-emergent adverse events | Up to 12 months | The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events. |
Countries
United States
Outcome results
None listed