Phase 4 N=20 Treatment

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

Actinic Cheilitis

Bottom Line

View on ClinicalTrials.gov: NCT02409732 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Participants With a Change in Clearance From Baseline — 1; 1; 9; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: aminolevulinic acid hydrochloride (Drug); Photodynamic therapy with blue light (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dartmouth-Hitchcock Medical Center
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a Change in Clearance From Baseline	1; 1; 9; 4; 5	—
SECONDARY Average Change in Participant Reported Pain	2.86; -0.76	—
SECONDARY Average Change in Local Skin Reactions to Blue Light Treatment	0.72; 0.58; 1.82	—
SECONDARY The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation	2; 0; 4; 1	—
SECONDARY Number of Participants With Adverse Events	1; 1; 1; 1	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02409732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.