Post-Procedural Biotech Cellulose Mask

NCT ID: NCT06065332

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2023-03-02

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.

Conditions

Temperature Change, Body

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Velez Intense Hydration Mask® (biotech cellulose face mask) Right Side

For 30 minutes after an aesthetic procedure, a Velez Intense Hydration Mask® (biotech cellulose face mask) was applied to the right side of the face

Group Type: EXPERIMENTAL

Velez Intense Hydration Mask® (biotech cellulose face mask)

Intervention Type: OTHER

Application to one randomized side half of a Velez Intense Hydration Mask® (biotech cellulose face mask)

Velez Intense Hydration Mask® (biotech cellulose face mask) Left Side

For 30 minutes after an aesthetic procedure, a Velez Intense Hydration Mask® (biotech cellulose face mask) was applied to the left side of the face

Group Type: EXPERIMENTAL

Velez Intense Hydration Mask® (biotech cellulose face mask)

Intervention Type: OTHER

Application to one randomized side half of a Velez Intense Hydration Mask® (biotech cellulose face mask)

Interventions

Velez Intense Hydration Mask® (biotech cellulose face mask)

Application to one randomized side half of a Velez Intense Hydration Mask® (biotech cellulose face mask)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Siperstein Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robyn D Siperstein, MD

Role: PRINCIPAL_INVESTIGATOR

Siperstein Dermatology Group

Locations

Siperstein Dermatology Group

Boynton Beach, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Velez

Identifier Type: -

Identifier Source: org_study_id