Clinical Trial: Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis

Brief Summary: To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.

Detailed Summary:

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 ninety 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.

Sponsor: Dartmouth-Hitchcock Medical Center

Current Primary Outcome: Clearance estimated as a percentage improvement from baseline [ Time Frame: 24 to 36 weeks ]

Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain [ Time Frame: 1 to 13 weeks ]
    Subject reported pain during and after blue light illumination using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable)
  • Local skin reactions [ Time Frame: 1 to 13 weeks ]
    Assessment of swelling, vesiculation/pustulation, erosion/ulceration, erythema, flaking/scaling, and crusting using a five-point ordinal scale (0: none to 4: severe) will be conducted after each treatment visit. The presence or absence of hyperpigmentation in the treatment area will also be documented after each treatment visit.
  • PDT reactions [ Time Frame: 1 to 13 weeks ]
    Other than those specified under local skin reactions.
  • Adverse events [ Time Frame: 24 to 36 weeks ]
    Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions.


Original Secondary Outcome: Same as current

Information By: Dartmouth-Hitchcock Medical Center

Dates:
Date Received: March 27, 2015
Date Started: April 2015
Date Completion: July 2017
Last Updated: May 12, 2017
Last Verified: May 2017