Actinic Cheilitis Clinical Trial
Official title:
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.
The study will consist of a screening visit, up to three scheduled treatments, and two
scheduled office visits. There can be a three-day window period for each scheduled visit in
order to accommodate the subject's schedule and unforeseen scheduling conflicts.
1. Visit 1 (Screening): Subjects can be screened for the study up to two weeks before Visit
2 (Baseline). During screening, the study will be reviewed, written informed consent
obtained, and eligibility confirmed. If applicable, the washout from prohibited
medications or treatments will be determined at this visit.
2. Visit 2 (Baseline): Following signed, written informed consent and confirmation of
eligibility, all subjects will have their lips photographed. Medical history,
dermatologic exam, urine pregnancy test (if applicable), review of concomitant
medications, clinical evaluations, and tolerability assessments will be performed at
this visit. Study medication application to clean skin will be followed by a 90 minute
incubation period under occlusion. Subsequently, patients will be exposed to blue light
therapy for 16 minutes and 40 seconds. Post-therapy assessments will be performed
afterwards, as well as education on appropriate sun protection methods.
3. Visits 3-4: Subjects will return every six weeks for up to two additional treatments.
Treatment will be discontinued once the patient has achieved clinical clearance.
Tolerability assessments, study medication application, blue light therapy, post-therapy
assessments, and photographs will be performed.
4. Visit 5-6 (End of Study): Subjects will return 12 and 24 weeks after the last treatment
for clinical evaluations, tolerability assessments, and photographs.
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