Actively Recruiting
Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma
Led by Benev Company, Inc. · Updated on 2024-05-16
90
Participants Needed
3
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and sign informed consent
- Healthy females 19 years and older
- Fitzpatrick skin types I through VI
- Diagnosed with melasma
- Willing to have radiofrequency microneedling treatment and follow treatment and follow-up schedules
- Willing to limit sun exposure and use sunscreen on treatment area every day during the study
- Agree to have photographs taken of the treatment area
- Willing to avoid using topical corticosteroids or retinoids during the study
- Agree to undergo the procedure on the treatment area
- Not pregnant or lactating and either post-menopausal, surgically sterilized, or using birth control at least 1 month before enrollment
- Willing to apply sunscreen once daily in the morning and every 2 hours thereafter
You will not qualify if you...
- Participation in another clinical trial involving drugs or devices on the treatment area within 3 months before or during this study
- Cosmetic treatments to the target area within 3 months before the study, including laser/light procedures, neuromodulators, facial peels, lightening creams, or facial surgery
- Use of fillers in the treatment area within 3 months before or during the study
- Use of prescription topicals on the treatment area within 1 month before treatment or topical agents causing sensitivity within 1 week before treatment
- Significant skin or inflammatory conditions in the treatment area before treatment, such as open wounds, hidradenitis, rash, infection, or dermatitis
- Pregnant, breastfeeding, or planning pregnancy
- Significant concurrent illnesses like diabetes, immune deficiencies, or use of immunosuppressive medications
- Use of medications causing sensitivity to light or hypersensitivity to light exposure
- History of keloid scarring, hypertrophic scarring, abnormal wound healing, or tendency to bruise
- History of skin cancers in the treatment area unless treated with no recurrence within 6 months
- History of epidermal or dermal disorders affecting collagen or microvascularity
- Skin conditions interfering with treatment as judged by the investigator
- Connective tissue diseases like lupus or scleroderma
- History of heat-stimulated diseases such as recurrent herpes simplex or shingles unless on prophylactic treatment
- Excessive tanning or inability to avoid tanning during the study
- Excessive facial hair in the treatment area that interferes with treatment
- Physical or mental conditions making participation unsafe or compliance difficult
- A 6-month washout required for recent changes in contraceptive use, recent delivery, or breastfeeding to reduce hormonal effects on melasma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Scripps Health
La Jolla, California, United States, 92037
Actively Recruiting
2
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, United States, 28207
Actively Recruiting
3
Refresh Dermatology
Houston, Texas, United States, 77081
Completed
Research Team
J
Jamie Solorsa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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