Evaluation of Broadband Light Treatment for Pigmented Skin Lesions (NCT05750914) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Broadband Light Treatment for Pigmented Skin Lesions
United States15 participantsStarted 2022-09-01
Plain-language summary
Evaluation of safety and efficacy of Broadband light treatment
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male or female, 18 years or older
* Fitzpatrick skin type I-IV
* Has visible signs of moderate to severe skin pigmentation
* Willing to not use any other procedure(s) in the treatment area during the study, such as laser- or light-based treatment, non-light-based device treatment such as radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler, chemical peel, or surgical procedure
* Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study. (applicable to female subjects only)
* Willing to have very limited sun exposure and use an approved sunscreen of SPF 30 or higher on the treatment area every day for the duration of the study, including the follow-up period
* Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes
* Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period
* Subject must be able to read, understand and sign Informed Consent Form
* Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions
Exclusion Criteria:
* Fitzpatrick skin type V-VI
* Participation in a clinical trial of another dev…