Dermal Cryotherapy in Patients Undergoing Abdominoplasty

A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.

Study Overview

• Status: Completed
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Dermal Cooling System

Detailed Description

This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Folsom, California, United States, 95638
      • Kaufman Plastic Surgery
    • Fremont, California, United States, 94538
      • Fremont Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects > 18 years of age.
2. Subjects eligible, consented, and scheduled for abdominoplasty.
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. Subject has medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., liposuction, mesotherapy, hydroquinone, corticosteroids, laser surgery).
2. Subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, Enbrel).
3. Subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
4. Subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline)
5. 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.
6. Subject is unable or unwilling to comply with the study requirements.
7. Subject has any dermatological conditions or scars (other than stretch marks) within the area of planned abdominoplasty excision that may interfere with the ability to obtain test sites for treatment or evaluation.
8. Subject has a history of abnormal wound healing or abnormal scarring.
9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
10. Patient is pregnant or intending to become pregnant within the next 6 months.
11. Patient is lactating or has been lactating in the past 9 months.
12. 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 patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with cryotherapy; Treatment with dermal cooling system.	Device: Dermal Cooling System; Treatment with dermal cooling system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic evaluation of treated skin	Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments.	1-180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access device or procedure-related adverse events	Assess adverse events and side effects.	1 - 180 days

Collaborators and Investigators

• Sponsor: R2 Dermatology
• Investigators: Principal Investigator: David Kaufman, MD, Kaufman Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: R2-15-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes