Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Aminolevulinic Acid; Topical Solution Vehicle; BLU-U; Cryotherapy
Intervention description: 20% ALA applied to face for one hour prior to 10 J/cm2 blue light; Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light; 10 J/cm2 blue light delivered at 10 mW/cm2; Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis

Summary:

      The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and
      effective in the treatment of actinic keratoses (AK) on the face, following treatment with
      liquid nitrogen cryotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Four to fifteen AKs on the face

          -  histologically confirmed presence of abnormal architecture and satellite atypical
             keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged
             skin adjacent to AKs

          -  at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck
             area within the past five years

        Exclusion Criteria:

          -  Pregnancy

          -  history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or
             photodermatosis

          -  lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated
             skin cancers within the Treatment Area

          -  skin pathology or condition which could interfere with the evaluation of the test
             product or requires the use of interfering topical or systemic therapy

          -  Subject is immunosuppressed

          -  unsuccessful outcome from previous ALA-PDT therapy

          -  currently enrolled in an investigational drug or device study

          -  has received an investigational drug or been treated with an investigational device
             within 30 days prior to the initiation of treatment

          -  known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl
             alcohol, laureth 4, polyethylene glycol)

          -  has an active herpes simplex infection OR a history of 2 or more outbreaks within the
             past 12 months, on the face

          -  use of the following topical preparations on the extremity to be treated:

               -  Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic
                  acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within
                  2 days

               -  Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks

               -  Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels,
                  5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical
                  treatments for AK within 8 weeks

          -  use of systemic retinoid therapy within 6 months