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

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: DUSA Pharmaceuticals, Inc.
• Treatments: Aminolevulinic Acid

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