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 Information
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
Administrative Informations
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