An interventional study of Dermal Cooling System in Skin Lesion, sponsored by R2 Dermatology. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by R2 Dermatology · Not applicable, Interventional, and Treatment
Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.
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.
Exclusion Criteria:
Dermal Cooling System
Device: Dermal Cooling System
Cryotherapy
Improvement in appearance in the treatment area
Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).
Time frame: 3-months
Incidence of procedure related adverse events
• Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events
Time frame: less than 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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R2 Dermatology