An interventional study of Velez Intense Hydration Mask® (biotech cellulose face mask) in Temperature Change, Body, sponsored by Siperstein Dermatology. Completed at 1 site in United States. Open to participants aged 22 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Siperstein Dermatology · Not applicable, Interventional, and Treatment
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.
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.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →Siperstein Dermatology is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Application to one randomized side half of a Velez Intense Hydration Mask® (biotech cellulose face mask)
Temperature
Change in skin temperature
Time frame: 30 minutes after the procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Siperstein Dermatology