Dermal Cooling System for Cryotherapy of Common Skin Conditions

NCT03282994 | Completed FDA Device

• 1 other identifier: R2-17-003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of procedure related adverse events

  less than 12 months

Study Arms (1)

Treatment with cryotherapy

EXPERIMENTAL

Dermal Cooling System

Device: Dermal Cooling System

Interventions

Dermal Cooling System DEVICE

Cryotherapy

Treatment with cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• R2 Dermatology: lead

Study Sites (3)

Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, 85255, United States

Location

Zel Skin and Laser Specialists

Edina, Minnesota, 55424, United States

Location

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Study Officials

• Kristine Tatsutani, PhD

  R2 Dermatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: July 19, 2017
• Primary Completion: November 17, 2018
• Study Completion: November 17, 2018
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)