Clinical trial NCT06065332: Post-Procedural Biotech Cellulose Mask
Official title: Randomized Split-Face Study Using a Post-Procedural Biotech Cellulose Mask to Improve Patient Comfort & Downtime
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature Change, Body
Lead sponsor: Siperstein Dermatology
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A dual center study was performed at a private practice in Boynton Beach and Boca Raton Florida. The study was carried out in accordance with the ethical guidelines and principles of the 1975 Declaration of Helsinki and good clinical practice. The protocol was approved on May 12th, 2022, by Sterling IRB.

Study Design:

The clinical research coordinator and investigator recruited, enrolled, and assigned 15 subjects into 3 arms, each with 5 subjects over two months. The side assigned a biotech cellulose mask for each subject was determined by random sorting using a computer-generated sequence and written on a label adhered to the mask packaging so the patient could remember while at home.

Treatment:

Topical anesthetic cream (benzocaine 20%, lidocaine 10%, and tetracaine 6%) was applied to the face for 30 minutes and wiped off with 70% isopropyl alcohol in all three arms. Those in arm 1 received a non-ablative fractionated thulium treatment (Moxi; Sciton) those in arm 2 received a microneedling with radiofrequency treatment (Secret; Cutera), and those in arm 3 received a fully ablative erbium yttrium aluminum garnet (Er:YAG) laser resurfacing (Contour TRL; Sciton). Immediately after the procedure a biotech cellulose mask was applied (Hydration mask; Velez by Vesna) and left on for thirty minutes. Then digital photography using Canfield's imaging system and Flir's thermal camera was done. In addition, a subject questionnaire on satisfaction, erythema, edema, and pain levels after the procedure was completed. Patients used the typical post-care treatment on both sides of their face such as Vaseline for laser resurfacing and a hydrating serum for the NAFR and MRF. They were given additional half-sided masks to apply to the same assigned side of their face at home for at least two hours each day for the duration of the study. They returned to the office daily for questionnaires and photographs until deemed fully healed by the primary investigator signifying the end of the study. At all follow up visits, the primary investigator assessed the subject for any side effects and subjects were asked about side effects in questionnaires.

Eligibility criteria: 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.

Primary outcomes:
measure: Temperature
timeFrame: 30 minutes after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Siperstein Dermatology Group
state: Florida
Study officials:
affiliation: Siperstein Dermatology Group
name: Robyn D Siperstein, MD
role: PRINCIPAL_INVESTIGATOR
References: