Skin Laxity
Conditions
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.
Interventions
DEVICEDermal Cooling System
Treatment with dermal cooling system.
Sponsors
R2 Dermatology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histologic evaluation of treated skin | 1-180 days | Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access device or procedure-related adverse events | 1 - 180 days | Assess adverse events and side effects. |
Countries
United States
Outcome results
None listed