Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma

NCT06415435 | Recruiting FDA Device

• 1 other identifier: VIOL-MEL-2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  28 days

• Percentage of subjects with an increase in satisfaction level assessed from Melasma Quality of Life questionnaire (MELQoL) after treatment compared to baseline

  28 days

• Statistical improvement of investigator Global Aesthetic Improvement Scale (GAIS)

  28 days

Study Arms (2)

Sylfirm X Treatment with Sunscreen

EXPERIMENTAL

Device: Radiofrequency Microneedling

No Treatment, Sunscreen Only

NO INTERVENTION

Interventions

Radiofrequency Microneedling DEVICE

Sylfirm X radiofrequency microneedling device

Sylfirm X Treatment with Sunscreen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Benev Company, Inc.: lead

Study Sites (3)

Scripps Health

La Jolla, California, 92037, United States

RECRUITING

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, 28207, United States

RECRUITING

Refresh Dermatology

Houston, Texas, 77081, United States

COMPLETED

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jamie Solorsa

CONTACT

9494572222; jamie@benev.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 16, 2024
• Study Start: May 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (3)