Temperature Change, Body Clinical Trial
Official title:
Randomized Split-Face Study Using a Post-Procedural Biotech Cellulose Mask to Improve Patient Comfort & Downtime
NCT number | NCT06065332 |
Other study ID # | Velez |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 7, 2022 |
Est. completion date | March 2, 2023 |
Verified date | September 2023 |
Source | Siperstein Dermatology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: There are many post-procedural treatments touted to improve comfort and decrease downtime, but very few prospective randomized studies. Aims: To analyze the safety and efficacy of a post-procedural biotech cellulose mask Patients/Method: Fifteen patients undergoing either a microneedling with radiofrequency (n=5), non-ablative fractional (n=5), or full erbium;YAG resurfacing (n=5) treatment were randomized to receive a Velez biotech cellulose mask on one side of the face for 30 minutes after the procedure and for two hours a day until healed. Canfield Visia photos and thermal photographs were taken 30 minutes after the procedure and daily until healed. The investigator and blind evaluators reviewed the photos and subjects answered daily questionnaires.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 2, 2023 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patients willing to undergo a cosmetic procedure - Patients willing to apply a mask for 30 minutes after the procedure and daily - Patients willing to return to the office to take photos daily and allow use of photos in publication Exclusion Criteria: - History of auto-immune conditions - History of keloids - History of severe anaphylactic reactions - Patients taking either anti-coagulants, chemotherapy, immunosuppressive agents, immunomodulatory agents, diuretics, antihistamines, or anti-inflammatory two weeks before or during planned treatments - Patients who are pregnant or nursing. |
Country | Name | City | State |
---|---|---|---|
United States | Siperstein Dermatology Group | Boynton Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Siperstein Dermatology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Temperature | Change in skin temperature | 30 minutes after the procedure |
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