Dermal Cooling System for Cryotherapy of Common Skin Conditions

Skin Lesion Clinical Trial

Official title:

Evaluation of the Dermal Cooling System for Cryotherapy of Common Skin Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282994
• Other study ID #: R2-17-003
• Status: Completed
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: November 17, 2018

Study information

• Verified date: August 2023
• Source: R2 Dermatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 17, 2018
• Est. primary completion date: November 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Diseases
• Skin Lesion

Intervention

Device:
• Dermal Cooling System
Cryotherapy

Locations

Country	Name	City	State
United States	Dermatology, Laser and Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Zel Skin and Laser Specialists	Edina	Minnesota
United States	Clear Dermatology & Aesthetics Center	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
R2 Dermatology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3-months
Secondary	Incidence of procedure related adverse events	• Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events	less than 12 months