Dermal Cryotherapy for Treatment of Pigmented Lesions

NCT02848742 | Completed

• 1 other identifier: R2-16-001
• Study Type: interventional
• Target: 377
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Pigmented Skin Lesion

Outcome Measures

Primary Outcomes (1)

• Reduction of pigmentation in treated lesions

  Changes in pigmentation graded using a 4-point standardized scale

  90 days

Secondary Outcomes (1)

• Evaluation of device- or procedure-related adverse events

  0 to 12 months

Study Arms (1)

Treatment with cryotherapy device

EXPERIMENTAL

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

Interventions

Dermal Cooling System DEVICE

Dermal cryotherapy

Treatment with cryotherapy device

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 one or more benign pigmented lesions (e.g., solar lentigines, melasma, freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment
• 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.
• Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
• 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.
• Subject has read and signed a written informed consent form.

You may not qualify if:

• 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)
• 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
• Scars or tattoos in the location of the treatment sites
• History of vitiligo, eczema, or psoriasis in the area of treatment
• 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.
• 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 unacceptable risk to the subject.

Sponsors & Collaborators

• R2 Dermatology: lead

Study Sites (2)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Arbutus Laser Centre

Vancouver, British Columbia, V6J 1Z6, Canada

Location

Study Officials

• Kristine Tatsutani, PhD

  R2 Dermatology, Inc.

  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: July 26, 2016
• First Posted: July 28, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)