Dermal Cryotherapy in Patients Undergoing Abdominoplasty

NCT02763306 | Completed FDA Device

• 1 other identifier: R2-15-002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Access device or procedure-related adverse events

  1 - 180 days

Study Arms (1)

Treatment with cryotherapy

EXPERIMENTAL

Treatment with dermal cooling system.

Device: Dermal Cooling System

Interventions

Dermal Cooling System DEVICE

Treatment with dermal cooling system.

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.
• Subjects eligible, consented, and scheduled for abdominoplasty.
• 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:

• 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).
• Subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, Enbrel).
• Subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
• Subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline)
• 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.
• Subject is unable or unwilling to comply with the study requirements.
• 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.
• Subject has a history of abnormal wound healing or abnormal scarring.
• Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Patient is pregnant or intending to become pregnant within the next 6 months.
• Patient is lactating or has been lactating in the past 9 months.
• 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.

Sponsors & Collaborators

• R2 Dermatology: lead

Study Sites (2)

Kaufman Plastic Surgery

Folsom, California, 95638, United States

Location

Fremont Plastic Surgery

Fremont, California, 94538, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• David Kaufman, MD

  Kaufman Plastic Surgery

  PRINCIPAL INVESTIGATOR

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 15, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)