Back to resultsDermal Cryotherapy in Patients Undergoing Abdominoplasty
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dermal Cooling System
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity
Eligibility Criteria
Inclusion Criteria:
- 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. -
Exclusion Criteria:
- 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.
Sites / Locations
- Kaufman Plastic Surgery
- Fremont Plastic Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with cryotherapy
Arm Description
Treatment with dermal cooling system.
Outcomes
Primary Outcome Measures
Histologic evaluation of treated skin
Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments.
Secondary Outcome Measures
Access device or procedure-related adverse events
Assess adverse events and side effects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02763306
Brief Title
Dermal Cryotherapy in Patients Undergoing Abdominoplasty
Official Title
Dermal Cryotherapy in Patients Undergoing Abdominoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R2 Dermatology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with cryotherapy
Arm Type
Experimental
Arm Description
Treatment with dermal cooling system.
Intervention Type
Device
Intervention Name(s)
Dermal Cooling System
Intervention Description
Treatment with dermal cooling system.
Primary Outcome Measure Information:
Title
Histologic evaluation of treated skin
Description
Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments.
Time Frame
1-180 days
Secondary Outcome Measure Information:
Title
Access device or procedure-related adverse events
Description
Assess adverse events and side effects.
Time Frame
1 - 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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. -
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kaufman, MD
Organizational Affiliation
Kaufman Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaufman Plastic Surgery
City
Folsom
State/Province
California
ZIP/Postal Code
95638
Country
United States
Facility Name
Fremont Plastic Surgery
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dermal Cryotherapy in Patients Undergoing Abdominoplasty
We'll reach out to this number within 24 hrs