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

Completed · Phase 4

Conditions studied: Actinic Cheilitis

In brief

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

Key facts

Study ID

NCT02409732

Run by

Dartmouth-Hitchcock Medical Center

People needed

24

Starts

2015-04-01

Expected to finish

2017-07-01

Last updated by the study team

2018-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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