Safety and Efficacy of the BTL-754 Device for Laser Skin Resurfacing Treatment of the Face (NCT06158438) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the BTL-754 Device for Laser Skin Resurfacing Treatment of the Face
Bulgaria56 participantsStarted 2023-11-16
Plain-language summary
This study will evaluate the clinical safety and the performance of the BTL-754 device (equipped with the 754-4 applicator) for reduction of facial wrinkles by the means of laser skin resurfacing treatment.
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* Healthy male or female subjects over 22 years of age seeking treatment for reduction of wrinkles.
* Presence of clearly visible wrinkles in the treated area when the face is relaxed as deemed appropriate by the Investigator.
* Subjects are willing to have polycarbonate eye shields placed for study treatment.
* Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form.
* Subjects are willing to maintain the usual skin care regimen during study participation with the exception when protocol specified ointments, moisturizers, and cleansers are required during the healing stage. Sunblock is required throughout the subject's participation in the study.
* Subjects are willing to abstain from other facial cosmetic procedures during the study; examples include, but are not limited to: laser or chemical resurfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial surgery, etc.
* Subjects are willing and able to comply with protocol requirements, including obtaining study-required digital photographs and assessments, post-care instructions, and returning for follow-up visits.
* Women of childbearing potential are required to use birth control measures.
Exclusion Criteria:
* Intolerance to anesthetic based agents
* Infectious disease
* Connective tissue disease
* Propensity for keloid formations
* Immunocompromised or compromised healing…
What they're measuring
1
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale