Post-Procedural Biotech Cellulose Mask
Condition: Temperature Change, Body
MeSH terms: Body Temperature Changes
Study type: Interventional

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.
    

Intervention name(s): Velez Intense Hydration Mask® (biotech cellulose face mask)
Intervention type(s): Other
Intervention description(s): Application to one randomized side half of a Velez Intense Hydration Mask® (biotech cellulose face mask)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment