VBeam Prima for Treatment of Photoaged Facial Skin (NCT03383705) | Clinical Trial Compass
UnknownNot Applicable
VBeam Prima for Treatment of Photoaged Facial Skin
United States20 participantsStarted 2017-11-15
Plain-language summary
This is an open-label, single-center study. Subjects in this study will receive up to four (4) facial treatments at 4-6 (±1) weeks interval, with the VBeam Prima device according to the study protocol. Subjects will return for follow-up (FU) visits at the clinic at 1 and 3 months following the last treatment.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Healthy Male or Female at least 18 years of age
✓. Photoaged facial skin with clinically visible background erythema, telangiectasia, or pigmented lesions
✓. Fitzpatrick Elastosis Score 2-9
✓. Fitzpatrick Skin Type I - VI
✓. Able to read, understand and sign the Informed Consent Form
✓. Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
✓. Willing to have limited sun exposure for the duration of the study, including the follow-up period
✓. Willing to have photographs taken of the treated area which will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications
Exclusion criteria
✕. Pregnant or planning to become pregnant during the study duration.
✕. Implant in the treated area (such as metal plates or screws) or an injected chemical substance.
✕. Known collagen (connective tissue) disorder, vascular disease (i.e. saphenous reflux), scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
✕. History of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
✕. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
✕. Undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
✕. Significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
✕. Infection or are suffering from a current or a history of significant skin conditions in the treated area and/or inflammatory skin conditions, including, but not limited to: photodermatoses, psoriasis, eczema, rash, severe open wound stage rosacea, open cuts or scrapes and active cold sores or herpes sores prior to study treatment or during the study treatment course.