Clinical trial NCT02409732: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Cheilitis
Keywords: Actinic cheilitis
Photodynamic therapy
Levulan
Blue light
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: DUSA Pharmaceuticals, Inc.
First posted: 2015-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With a Change in Clearance From Baseline
timeFrame: Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)
Secondary outcomes:
measure: Average Change in Participant Reported Pain
timeFrame: Baseline to Week 36
measure: Average Change in Local Skin Reactions to Blue Light Treatment
timeFrame: Baseline to Week 36
measure: The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
timeFrame: Baseline to Week 36
measure: Number of Participants With Adverse Events
timeFrame: Baseline to Week 36
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Michael S Chapman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ribeiro CF, Souza FH, Jordao JM, Haendchen LC, Mesquita L, Schmitt JV, Faucz LL. Photodynamic therapy in actinic cheilitis: clinical and anatomopathological evaluation of 19 patients. An Bras Dermatol. 2012 May-Jun;87(3):418-23. doi: 10.1590/s0365-05962012000300011.
citation: Zaiac M, Clement A. Treatment of actinic cheilitis by photodynamic therapy with 5-aminolevulinic acid and blue light activation. J Drugs Dermatol. 2011 Nov;10(11):1240-5.