Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of ā¦ (NCT03944278) | Clinical Trial Compass
CompletedNot Applicable
Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions
United States15 participantsStarted 2019-04-12
Plain-language summary
Evaluate the Thulium laser device for skin resurfacing procedures, or as a treatment for pigmented lesions (age or sun spots) or dyschromia; or cutaneous lesions such as, but not limited to, actinic keratosis, melasma, fine rhytides; or as a method of improving skin tone and skin texture
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Female or Male, 18 years and older
ā. Fitzpatrick Skin Type I-VI
ā. Subject has visible signs of moderate sun-damages and/or aging facial skin with visible areas of fine rhytides, pigmentation, and erythema or telangiectasia.
ā. Desires non-ablative photo-revitalization of the skin.
ā. Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period.
ā. Subject must be able to read, understand and sign the Informed Consent Form.
ā. Must be willing and able to adhere to the treatment and follow-up schedule and post- treatment care instructions.
ā. Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
Exclusion criteria
ā. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
ā. Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
ā. Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.