Clinical trial NCT03282994: Dermal Cooling System for Cryotherapy of Common Skin Conditions
Official title: Evaluation of the Dermal Cooling System for Cryotherapy of Common Skin Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Lead sponsor: R2 Dermatology
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in appearance in the treatment area
timeFrame: 3-months
Secondary outcomes:
measure: Incidence of procedure related adverse events
timeFrame: less than 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center
state: Arizona
city: Edina
country: United States
facility: Zel Skin and Laser Specialists
state: Minnesota
city: Charlotte
country: United States
facility: Dermatology, Laser and Vein Specialists of the Carolinas
state: North Carolina
Study officials:
affiliation: R2 Dermatology
name: Kristine Tatsutani, PhD
role: STUDY_DIRECTOR
References: