A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal (NCT02635880) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal
United States32 participantsStarted 2015-09
Plain-language summary
To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for removal of benign pigmented lesions.
Who can participate
Age range18 Years – 65 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:
* Female or Male, 18 to 65 years of age (inclusive).
* Fitzpatrick Skin Type I - III (Appendix 3).
* Clinical diagnosis of benign pigmented lesions located on the hand, body or face.
* Presence of 5 or more benign pigmented lesions in the treatment area, ranging in diameter from 2 to 8 mm.
* Has not used any prescription or over-the-counter topical creams (such as hydroquinone, retinoids or corticosteroids) in the designated treatment area within 4 weeks of enrollment in the study and is willing to refrain from use for the duration of the study.
* Subject must be able to read, understand and sign the Informed Consent Form.
* Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
* Wiling to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and 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.
* Agree to not undergo any other procedure(s) for the treatment of BPL during the study.
* 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 stu…
What they're measuring
1
Percentage of Participants With Change of Treated Lesions
Timeframe: Baseline and 6 weeks post-final treatment