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A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP (NCT03024060)

The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.
  • Drug: ALA
    20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
    • Levulan Kerastick
    • Aminolevulinic Acid
  • Drug: Vehicle
    Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
    • Topical Solution Vehicle
  • Device: IBL 20 mW
    10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
    • Investigational Blue Light
  • Device: IBL 10 mW
    10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
    • Investigational Blue Light
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp
Exclusion Criteria:
  • Pregnancy
  • grade 3 and/or atypical >1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area
  • 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 active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area
  • 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 of initiation of treatment.
  • Curettage or Cryotherapy within 2 weeks of initiation of treatment
  • Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
  • Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
  • use of systemic retinoid therapy within 6 months of initiation of treatment.

7 locations

United States (7)
  • Therapeutics Clinical Research
    not yet recruiting
    San Diego, California, United States, 92123
  • Altman Dermatology Associates
    not yet recruiting
    Arlington Heights, Illinois, United States, 60005
  • Shideler Clinical Research Center
    not yet recruiting
    Carmel, Indiana, United States, 46032
  • The Indiana Clinical Trials Center, PC
    not yet recruiting
    Plainfield, Indiana, United States, 46168
  • Minnesota Clinical Study Center
    not yet recruiting
    Fridley, Minnesota, United States, 55432
  • DermResearch, Inc.
    not yet recruiting
    Austin, Texas, United States, 78759
  • Virginia Clinical Research, Inc.
    not yet recruiting
    Norfolk, Virginia, United States, 23507
Status:
not yet recruiting
Type:
Interventional
Phase:
Start:
28 February, 2017
Updated:
06 February, 2017
Participants:
135
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