Dermal Cryotherapy for Treatment of Pigmented Lesions

Evaluation of a New Dermal Cryotherapy System for the Treatment of Benign Pigmented Lesions

Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions.

Study Overview

• Status: Completed
• Conditions: Pigmented Skin Lesion
• Intervention / Treatment: Device: Dermal Cooling System

Detailed Description

This study is a prospective, non-randomized, multi-center study of the Dermal Cooling System to verify that the device causes a reduction in pigmentation in benign pigmented lesions, and to determine at what parameters the device is most effective.

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6J 1Z6
      • Arbutus Laser Centre
• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects > 18 years of age.
2. Subject has one or more benign pigmented lesions (e.g., solar lentigines, melasma, freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment
3. Subject is willing to have up to 40 treatment sites and/or an area up to 8 square inches treated depending on the size and nature of the lesions identified.
4. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
5. Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated areas for the duration of the study, including the follow-up period, if requested.
6. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
2. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
3. Scars or tattoos in the location of the treatment sites
4. History of vitiligo, eczema, or psoriasis in the area of treatment
5. History of melanoma
6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
7. History of abnormal wound healing or abnormal scarring
8. Inability or unwillingness to comply with the study requirements.
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 unacceptable risk to the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment with cryotherapy device; To include subjects with one or more benign pigmented lesions who are willing to have the pigmented skin exposed to cooling with the Dermal Cooling System.	Device: Dermal Cooling System; Dermal cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pigmentation in treated lesions	Changes in pigmentation graded using a 4-point standardized scale	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of device- or procedure-related adverse events	Side effects, discomfort assessments both during treatment and follow-up	0 to 12 months

Collaborators and Investigators

• Sponsor: R2 Dermatology

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: R2-16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No