Dermal Cryotherapy for Treatment of Pigmented Lesions

Not Applicable

Completed

• Conditions: Pigmented Skin Lesion
• Interventions: Device: Dermal Cooling System

• Registration Number: NCT02848742
• Lead Sponsor: R2 Dermatology

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-28
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with cryotherapy device	Dermal Cooling System	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.

Primary Outcome Measures

Name	Time	Method
Reduction of pigmentation in treated lesions	90 days	Changes in pigmentation graded using a 4-point standardized scale

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Arbutus Laser Centre; 🇨🇦 Vancouver, British Columbia, Canada