An interventional study of Dermal Cooling System in Skin Lesion, sponsored by R2 Dermatology. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by R2 Dermatology · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Dermal Cooling System will be used in all eligible subjects.
Device: Dermal Cooling System
Controlled localized cooling may be applied to lesions using the Dermal Cooling System.
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).
Time frame: up to 3 months
Incidence of treatment-emergent adverse events
The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.
Time frame: Up to 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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R2 Dermatology