Daylight Photodynamic Therapy for Actinic Keratosis
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Aminolevulinic Acid Topical 20% Topical Solution; BLU-U blue light phototherapy illuminator
Intervention description: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).; Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized (1:1:1), single-blind controlled trial with parallel group design
Masking: Single (Investigator)
Masking description: This is a single-blinded study, as the subject cannot be blinded to treatment. Disease assessments and aminolevulinic acid (ALA) application will be performed by the blinded investigator. History, concomitant medications, randomization, light exposure, symptom assessment, and Skindex-16 will be administered by the unblinded study coordinator.
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratoses; photodynamic therapy; aminolevulinic acid; precancerous skin lesion

Summary:

      This is a randomized, single-blind controlled trial with parallel group design to determine
      whether daylight photodynamic therapy (PDT) affords a reduction in treatment symptoms of
      pain, burning, and pruritus as measured by 1) symptom level during the treatment period and
      2) pain at the end of treatment exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults at least 18 years old.

          -  Subjects must be able to read, sign, and understand the informed consent

          -  Subjects have at least 4 and no more than 20 clinically typical, visible actinic
             keratoses in the target treatment area on the face or scalp.

          -  Subject must be willing to forego any other treatments for AK in the treatment area on
             the face or scalp, during the study period, and for 14 days prior to screening;
             including cryotherapy, topical 5-fluorouracil, imiquimod, and ingenol mebutate.

          -  Subjects who have previously received PDT must undergo at least an 8-week washout
             period prior to enrollment in study.

          -  Subject must be willing and able to participate in the study and to comply with all
             study requirements including concomitant medication and other treatment restrictions,
             and telephone interview.

          -  If subject is a female of childbearing potential she must have a negative urine
             pregnancy test result prior to study treatment initiation and must agree to use an
             approved method of birth control while enrolled in the study. Women who are pregnant,
             lactating, or planning to become pregnant during the study period are excluded from
             the study.

        Exclusion Criteria:

          -  Subjects with any dermatologic disease in the treatment area that may be exacerbated
             by the treatment proposed or that might impair the evaluation of AKs.

          -  Subjects who are currently participating in another clinical study or have completed
             another clinical study with an investigational drug or device on the study area within
             30 days prior to study treatment initiation.

          -  Subjects with any medical condition that, in the opinion of the investigator, makes
             the patient unsuitable for the trial.