Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: ALA; Topical Solution Vehicle; IBL 10 mW; Microneedle lesion preparation; IBL 20 mW
Intervention description: 20% ALA applied to face prior to light treatment; Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment; 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds; Microneedling of all visible/palpable AK lesions prior to solution application.; 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
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: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis

Summary:

      The purpose of this study is to determine the viability of microneedle lesion preparation
      (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis
      (AK) field on the face.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Four to eight AKs on the face

        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

          -  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

               -  Curettage or Cryotherapy within 2 weeks of initiation of treatment

               -  Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks

               -  Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5
                  fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments
                  for AK within 8 weeks

          -  use of systemic retinoid therapy within 6 months