Status:
COMPLETED
Dermal Cooling System for Cryotherapy of Common Skin Conditions
Lead Sponsor:
R2 Dermatology
Conditions:
Skin Lesion
Eligibility:
All Genders
18+ years
Phase:
NA
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 associate...
Eligibility Criteria
Inclusion
- Male or female subjects \> 18 years of age.
- Subject has benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.
- Subject is willing to have up to 40 test sites treated.
- Subject has read and signed a written informed consent form.
Exclusion
- Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).
- 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.
- History of melanoma.
- Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
- History of abnormal wound healing or abnormal scarring
- Inability or unwillingness to comply with the study requirements.
- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Subject is lactating.
- Current enrollment in a clinical study of any other unapproved investigational drug or device.
- 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.
Key Trial Info
Start Date :
July 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03282994
Start Date
July 19 2017
End Date
November 17 2018
Last Update
August 30 2023
Active Locations (3)
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1
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, United States, 85255
2
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424
3
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207