Actinic Keratoses
Conditions
Brief summary
The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.
Detailed description
This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses
Interventions
PROCEDUREPhotodynamic therapy
Photodynamic therapy applied to actinic keratoses
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years * Have a t least 4 nonhypertrophic AK lesions on the body * The subjects are in good health * The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator
Exclusion criteria
* Subjects who are pregnant or lactating * Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis * Subjects with use of photosensitizing drugs within 1 week of study start * Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry * Subjects with systemic steroid therapy within 4 weeks before study entry * Subjects who received previous treatment of target AKs * Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry * Subjects with prior history of hypersensitivity reactions to lidocaine * Subjects who are unable to understand the protocol or to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual assessment of lesions | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Patient subjective assessment and Safety | 4 weeks |
Countries
United States
Outcome results
None listed