Clinical trial NCT02763306: Dermal Cryotherapy in Patients Undergoing Abdominoplasty
Official title: Dermal Cryotherapy in Patients Undergoing Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lead sponsor: R2 Dermatology
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Histologic evaluation of treated skin
timeFrame: 1-180 days
Secondary outcomes:
measure: Access device or procedure-related adverse events
timeFrame: 1 - 180 days
Other outcomes:
Locations:
city: Folsom
country: United States
facility: Kaufman Plastic Surgery
state: California
city: Fremont
country: United States
facility: Fremont Plastic Surgery
state: California
Study officials:
affiliation: Kaufman Plastic Surgery
name: David Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References: