Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT02409732
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02409732
Study Brief:
Protocol Section:
NCT02409732