Temperature Change, BodyNCT06065332
Post-Procedural Biotech Cellulose Mask
A study testing Velez Intense Hydration Mask® (biotech cellulose face mask) in people with Temperature Change, Body, run by Siperstein Dermatology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Velez Intense Hydration Mask® (biotech cellulose face mask)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Siperstein Dermatology Group
Boynton Beach, Florida, 33472
About this study
Official title: Randomized Split-Face Study Using a Post-Procedural Biotech Cellulose Mask to Improve Patient Comfort & Downtime
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.
Read the 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
- Being tested
- Velez Intense Hydration Mask® (biotech cellulose face mask)
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Velez Intense Hydration Mask® (biotech cellulose face mask) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Change in skin temperature
Measured: 30 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start7 Nov 2022
- Primary completion9 Dec 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siperstein Dermatology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robyn D Siperstein, MD, Principal investigator, Siperstein Dermatology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065332
- Sponsor's protocol ID
- Velez
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Split-Face Study Using a Post-Procedural Biotech Cellulose Mask to Improve Patient Comfort & Downtime
- ClinicalTrials.gov ID
- NCT06065332
- Acronym / sponsor ID
- Velez
- Conditions
- Temperature Change, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Siperstein DermatologyUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Velez Intense Hydration Mask® (biotech cellulose face mask) Right Side | Experimental | 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 right side of the face |
| Velez Intense Hydration Mask® (biotech cellulose face mask) Left Side | Experimental | 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 |
Who may qualify
- Ages
- 22 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Velez Intense Hydration Mask® (biotech cellulose face mask)Application to one randomized side half of a Velez Intense Hydration Mask® (biotech cellulose face mask) | Other | Velez Intense Hydration Mask® (biotech cellulose face mask) Left Side, Velez Intense Hydration Mask® (biotech cellulose face mask) Right Side |
Primary outcome
Temperature
Time frame: 30 minutes after the procedure
Change in skin temperature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn D Siperstein, MD principal investigator
Siperstein Dermatology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Velez Intense Hydration Mask® (biotech cellulose face mask) in people with Temperature Change, Body, run by Siperstein Dermatology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: 30 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.