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

Phase 4

Completed

Conditions: Actinic Cheilitis

Interventions: Drug: aminolevulinic acid hydrochloride
Procedure: Photodynamic therapy with blue light

Registration Number: NCT02409732

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Change in Clearance From Baseline	Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)	Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.

Secondary Outcome Measures

Name	Time	Method
Average Change in Participant Reported Pain	Baseline to Week 36	Subject reported pain before, during and after blue light illumination was documented using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable). The maximum change in pain is 10 for each occurrence (pain before compared to during treatment and pain during compared to after treatment). This is multiplied by the number of subjects and then divided by the number of treatments to generate the range. The summation of the change between subject reported pain prior to compared to during blue light treatment was divided by the total number of treatments to obtain the average value. The summation of the change between subject reported pain during compared to after blue light treatment was divided by the total number of treatments to obtain the average value.
Average Change in Local Skin Reactions to Blue Light Treatment	Baseline to Week 36	Assessments of swelling, erythema, and flaking/scaling were conducted after each treatment and two days post-treatment using a five-point ordinal scale (0: none to 4: severe). The average change in swelling, erythema and flaking/scaling after each treatment and two days post treatment were divided by the 50 total treatments to obtain the average value.
The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation	Baseline to Week 36	Assessments of vesiculation/pustulation, erosion/ulceration, and crusting were conducted immediately after each blue light treatment using a five-point ordinal scale (0: none to 4: severe). The presence or absence of hyperpigmentation in the treatment area was also documented after each treatment visit. The total number of participants who developed a local skin reaction is documented.
Number of Participants With Adverse Events	Baseline to Week 36	Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions.