Post-Procedural Biotech Cellulose Mask

NCT06065332 | Completed

• 1 other identifier: Velez
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

• Temperature

  Change in skin temperature

  30 minutes after the procedure

Study Arms (2)

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

EXPERIMENTAL

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

Other: Velez Intense Hydration Mask® (biotech cellulose face mask)

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

EXPERIMENTAL

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

Other: Velez Intense Hydration Mask® (biotech cellulose face mask)

Interventions

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

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siperstein Dermatology: lead

Study Sites (1)

Siperstein Dermatology Group

Boynton Beach, Florida, 33472, United States

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robyn D Siperstein, MD

  Siperstein Dermatology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The blind evaluator were not aware which side of the face received the mask
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 3, 2023
• Study Start: November 7, 2022
• Primary Completion: December 9, 2022
• Study Completion: March 2, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)