Evaluation of a New Dermal Cryotherapy System

NCT02744794 | Completed

• 1 other identifier: R2-15-001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Skin Lightening

Outcome Measures

Primary Outcomes (1)

• Skin pigmentation changes

  Changes in pigmentation graded using a 7-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

EXPERIMENTAL

Treatment with dermal cooling system.

Device: Dermal Cooling System

Interventions

Dermal Cooling System DEVICE

Treatment with cryotherapy.

Treatment with cryotherapy

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 is willing to have up to 40 test sites treated on aesthetically discreet skin.
• Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
• Subject has read and signed a written informed consent form.

You may not qualify if:

• Fitzpatrick skin type VI.
• Physician prescribed, medical or surgical treatment 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
• Dermatological conditions or scars in the location of the treatment sites
• History of melanoma, personal or first degree relative
• 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 study requirments.
• 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 (3)

Center of Dermatology and Laser Surgery

Sacramento, California, 65819, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Bowes Dermatology

Miami, Florida, 33133, United States

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: April 18, 2016
• First Posted: April 20, 2016
• Study Start: April 27, 2015
• Primary Completion: March 20, 2018
• Study Completion: June 12, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)