Evaluation of a New Dermal Cryotherapy System

Not Applicable

Completed

• Conditions: Skin Lightening

• Registration Number: NCT02744794
• Lead Sponsor: R2 Dermatology

Brief Summary

A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.

Detailed Description

This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.

Study Timeline

• Study Start: 2015-04-27
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-20
• Primary Completion: 2018-03-20
• Study Completion: 2018-06-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

1. Male or female subjects > 18 years of age.
2. Subject is willing to have up to 40 test sites treated on aesthetically discreet skin.
3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria

1. Fitzpatrick skin type VI.
2. Physician prescribed, medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
3. 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
4. Dermatological conditions or scars in the location of the treatment sites
5. History of melanoma, personal or first degree relative
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 study requirments.
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

Primary Outcome Measures

Name	Time	Method
Skin pigmentation changes	90 days	Changes in pigmentation graded using a 7-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 (3)

Center of Dermatology and Laser Surgery; 🇺🇸 Sacramento, California, United States

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

Bowes Dermatology; 🇺🇸 Miami, Florida, United States