Dermal Cryotherapy for Treatment of Pigmented Lesions

NCT ID: NCT02848742

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 377 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-03-31

Brief Summary

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

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.

Conditions

Pigmented Skin Lesion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dermal Cooling System

Intervention Type: DEVICE

Dermal cryotherapy

Interventions

Dermal Cooling System

Dermal cryotherapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

R2 Dermatology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristine Tatsutani, PhD

Role: STUDY_DIRECTOR

R2 Dermatology, Inc.

Locations

Diablo Clinical Research

Walnut Creek, California, United States

Arbutus Laser Centre

Vancouver, British Columbia, Canada

Countries

United States; Canada

Other Identifiers

R2-16-001

Identifier Type: -

Identifier Source: org_study_id