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

Brief Title

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

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 Description

      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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Number of Participants With a Change in Clearance From Baseline

Secondary Outcome

 Average Change in Participant Reported Pain

Condition

Actinic Cheilitis

Intervention

aminolevulinic acid hydrochloride

Study Arms / Comparison Groups

 PDT

Description:  PDT with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks for up to three treatments

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

24

Start Date

April 2015

Completion Date

July 2017

Primary Completion Date

July 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Must be able to understand and voluntarily sign an informed consent form

          -  Must be male or female ≥ 18 years of age at the time of consent

          -  Must be able to adhere to the study visit schedule and other protocol requirements

          -  Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy
             specimen or clinical presentation

        Exclusion Criteria:

          -  Inability to provide voluntarily consent or mentally incompetent

          -  Active herpes labialis lesions

          -  Subjects with any condition which places the subject at unacceptable risk if he/she
             were to participate in the study, or confounds the ability to interpret data from the
             study

          -  Subjects with any other skin condition that might affect the evaluation of the study
             disease

          -  Pregnant or breastfeeding female subjects

          -  Subjects who have used any investigational medication within one month prior to study
             entry

          -  Subjects who have been previously exposed to PDT and/or topical Levulan therapy for
             the treatment of actinic cheilitis

          -  Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5%
             fluorouracil) within three months of study entry

          -  Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six
             months of study entry

          -  Subjects who are currently using photosensitizing agents (e.g. thiazides,
             tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk
             of augmented photosensitivity

          -  Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards,
             construction workers, frequent sunbed users, etc.)

          -  Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity
             to porphyrins, or photodermatosis

          -  Subjects with a known hypersensitivity to Levulan

          -  Subjects who are immunocompromised
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael S Chapman, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02409732

Organization ID

D15043 28525

Responsible Party

Principal Investigator

Study Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

 DUSA Pharmaceuticals, Inc.

Study Sponsor

Michael S Chapman, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center

Verification Date

October 2018