MelasmaNCT06415435
Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma
A study testing Radiofrequency Microneedling in people with Melasma, run by Benev Company, Inc. at 3 sites in United States.
Trial summary
Microneedling radiofrequency technology has been shown in clinical studies to improve skin quality, tone, pigment, and to treat various skin conditions related to aging. The purpose of this study is to evaluate efficacy and safety of Sylfrim X device for the treatment of melasma. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Radiofrequency Microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2023to 1 Oct 2024
- 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be able to read, understand and sign informed consent form.
- Healthy females, 19 and older
- Fitzpatrick I-VI
- Has melasma
- Willing to have RF microneedling treatment and able to adhere to treatments, follow up schedule, and post-treatment instructions
- Willing to have limited sun exposure and use sunscreen on treatment area everyday for duration of study
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- Willing to have photographs taken of treatment area and agree to use of photographs
- Willing to refrain from using topical corticosteroids, or retinoids
- Agree to undergo procedure in treatment area during study
- Females: not pregnant, or lactating and is either post-menopausal, surgically sterilized, or using birth control at least 1 month prior to enrollment
- Willing to wear sunscreen and apply once daily in morning and every 2 hours
Who cannot join
- Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser/light procedures, and those used for general aesthetic correction, neuromodulators, facial peel, lightening creams, or facial surgery.
- Any fillers within 3 months prior to enrollment or during the study.
- Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
- . Pregnant and/or breastfeeding or planning to become pregnant.
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- Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
- Any use of any medication that is known to increase sensitivity to light or hypersensitivity to light exposure according to the Investigator's discretion.
- History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
- If you have a history of squamous cell carcinoma or melanoma in the treatment area, this includes basal cell carcinoma unless: basal cell carcinoma was treated or excised with no evidence of reoccurrence within the past 6 months prior to screening. Squamous cell carcinoma in situ, which has been treated or excised without evidence or reoccurrence within the past 6 months prior to screening.
- . History of epidermal or dermal disorders (particularly if involving collagen or micro vascularity), including collagen vascular disease or vasculitis disorders.
- A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- Sponsor: VIOL Version 1, 25APR2022 Protocol: VIOL-MEL-2022 Page 18 of 47
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
- Excessive facial hair in the area to be treated (beards, sideburns, and/or mustache,) that would interfere with diagnosis, assessment, and treatment.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.
- To reduce potential effects of hormonal changes in melasma, a 6-month washout period is required for female subjects who have recently stopped or started contraceptive use, have recently delivered an infant, or have stopped breastfeeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207
Razia Ludin, 704-973-3687, raziaL@carolinaskin.com
Gilly Munavalli, MD
- Completed
Refresh Dermatology
Houston, Texas, 77081
- Recruiting
Scripps Health
La Jolla, California, 92037
Joy Biggers, 858-554-5273, biggers.joy@scrippshealth.org
Victor Ross, MD
About this study
Official title: A Multi-Center, Open-Label, Prospective Study of the Sylfirm X Device for the Treatment of Melasma
Microneedling radiofrequency technology has been shown in clinical studies to improve skin quality, tone, pigment, and to treat various skin conditions related to aging.
The purpose of this study is to evaluate efficacy and safety of Sylfrim X device for the treatment of melasma.
- Conditions
- Melasma
- Being tested
- Radiofrequency Microneedling
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency MicroneedlingDevice
Sylfirm X radiofrequency microneedling device
| Study group | Role | What they receive |
|---|---|---|
| Sylfirm X Treatment with Sunscreen | Experimental | Not described Receives: Device: Radiofrequency Microneedling |
| No Treatment, Sunscreen Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100%
Success criteria: 80% accuracy in identifying the baseline photo from post-treatment photos.
Measured: 28 days
Secondary outcomes (3)
Change in Modified Melasma Area and Severity Index (mMASI) scale measured by investigator (range 0-24), a lower score indicating clearer skin.
The Modified Melasma Area and Severity Index scale will be utilized to grade melasma severity. Success criteria: improvement by 1 point, ie. at least 1 point lower than baseline.
Measured: 28 days
Percentage of subjects with an increase in satisfaction level assessed from Melasma Quality of Life questionnaire (MELQoL) after treatment compared to baseline
MELQoL is a questionnaire on a scale of 0 to 7 on how the patients feel about skin appearance, skin condition, embarrassment about skin condition, etc.
Measured: 28 days
Statistical improvement of investigator Global Aesthetic Improvement Scale (GAIS)
Success criteria: On a scale of -1 (skin got worse) to 3 (skin very much improved), incidence of subject improvement was statistically significant.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 May 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies 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
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benev Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415435
- Sponsor's protocol ID
- VIOL-MEL-2022
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Prospective Study of the Sylfirm X Device for the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT06415435
- Acronym / sponsor ID
- VIOL-MEL-2022
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Benev Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 May 2024 (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.
Microneedling radiofrequency technology has been shown in clinical studies to improve skin quality, tone, pigment, and to treat various skin conditions related to aging.
The purpose of this study is to evaluate efficacy and safety of Sylfrim X device for the treatment of melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sylfirm X Treatment with Sunscreen | Experimental | Device: Radiofrequency Microneedling |
| No Treatment, Sunscreen Only | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject must be able to read, understand and sign informed consent form.
- Healthy females, 19 and older
- Fitzpatrick I-VI
- Has melasma
- Willing to have RF microneedling treatment and able to adhere to treatments, follow up schedule, and post-treatment instructions
Key exclusion criteria (19 listed)
- Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser/light procedures, and those used for general aesthetic correction, neuromodulators, facial peel, lightening creams, or facial surgery.
- Any fillers within 3 months prior to enrollment or during the study.
- Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
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 |
|---|---|---|
| Radiofrequency MicroneedlingSylfirm X radiofrequency microneedling device | Device | Sylfirm X Treatment with Sunscreen |
Primary outcome
Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100%
Time frame: 28 days
Success criteria: 80% accuracy in identifying the baseline photo from post-treatment photos.
3 secondary outcomes
Change in Modified Melasma Area and Severity Index (mMASI) scale measured by investigator (range 0-24), a lower score indicating clearer skin.
Time frame: 28 days
Percentage of subjects with an increase in satisfaction level assessed from Melasma Quality of Life questionnaire (MELQoL) after treatment compared to baseline
Time frame: 28 days
Statistical improvement of investigator Global Aesthetic Improvement Scale (GAIS)
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Microneedling in people with Melasma, run by Benev Company, Inc. at 3 sites 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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Solorsa (9494572222 ext. 206, jamie@benev.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100% (time frame: 28 days). 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 16 May 2024.