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Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick

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ClinicalTrials.gov Identifier: NCT02281136
Recruitment Status : Completed
First Posted : November 3, 2014
Results First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
DUSA Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.

Condition or disease Intervention/treatment Phase
Keratosis, Actinic Drug: Aminolevulinic Acid (ALA) Device: BLU-U Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions
Study Start Date : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015


Arm Intervention/treatment
Experimental: ALA
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Drug: Aminolevulinic Acid (ALA)
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Other Name: Levulan Kerastick

Device: BLU-U
10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
Other Name: Blue Light Photodynamic Therapy (PDT)




Primary Outcome Measures :
  1. Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA [ Time Frame: 1 day ]
    Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples wiere taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.

  2. Time at Which Cmax is Attained (Tmax) for ALA [ Time Frame: 1 day ]
    Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.

  3. AUCt [ Time Frame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose ]
    AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration

  4. The Terminal Exponential Half-life (T1/2,z) [ Time Frame: 1 day ]
    The terminal slope will be calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.


Secondary Outcome Measures :
  1. Hyperpigmentation [ Time Frame: Baseline ]
    HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

  2. Hyperpigmentation [ Time Frame: 24 hours after PDT ]
    HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

  3. Hyperpigmentation [ Time Frame: Week 4 ]
    HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

  4. Hypopigmentation [ Time Frame: Baseline ]
    HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

  5. Hypopigmentation [ Time Frame: 24 hours post PDT#1 ]
    HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

  6. Hypopigmentation [ Time Frame: Week 4 ]
    HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

  7. Erythema [ Time Frame: Baseline ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  8. Erythema [ Time Frame: 5 Minutes after PDT ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  9. Erythema [ Time Frame: 24 hours after PDT #1 ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  10. Erythema [ Time Frame: Week 4 ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  11. Edema [ Time Frame: Baseline ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  12. Edema [ Time Frame: 5 Minutes after PDT ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  13. Edema [ Time Frame: 24 hours after PDT #1 ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  14. Edema [ Time Frame: Week 4 ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  15. Stinging/Burning [ Time Frame: Baseline ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

  16. Stinging/Burning [ Time Frame: During PDT ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

  17. Stinging/Burning [ Time Frame: 5 Minutes after PDT ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

  18. Stinging/Burning [ Time Frame: 24 hours after PDT #1 ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

  19. Stinging/Burning [ Time Frame: Week 4 ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

  20. Scaling and Dryness [ Time Frame: Baseline ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  21. Scaling and Dryness [ Time Frame: 24 hours after PDT #1 ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  22. Scaling and Dryness [ Time Frame: Week 4 ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  23. OOZING/VESICULATION/CRUSTING [ Time Frame: Baseline ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  24. OOZING/VESICULATION/CRUSTING [ Time Frame: 24 hours after PDT #1 ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  25. OOZING/VESICULATION/CRUSTING [ Time Frame: Week 4 ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 6 Grade 1/2 AKs on one upper extremity AND
  • At least 12 Grade 1/2 AKs on the OTHER upper extremity

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
  • Body Mass Index (BMI) > 32.0 kg/m2
  • skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
  • significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
  • tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
  • a history of lead poisoning or a history of a significant exposure to lead or a screening lead level above 6μg/dl
  • tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
  • positive drug screen at Screening
  • Screening safety labs are clinically significant in the opinion of the investigator
  • major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
  • 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 Visit 2 (Baseline)
  • known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
  • use of the following topical preparations on the extremities 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
    • Cryotherapy within 2 weeks of initiation of treatment
    • Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
    • Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281136


Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
DUSA Pharmaceuticals, Inc.
Investigators
Study Director: Stuart Marcus, MD, PhD DUSA Pharmaceuticals, Inc.

Responsible Party: DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02281136     History of Changes
Other Study ID Numbers: CP0110
First Posted: November 3, 2014    Key Record Dates
Results First Posted: January 13, 2017
Last Update Posted: January 13, 2017
Last Verified: November 2016

Keywords provided by DUSA Pharmaceuticals, Inc.:
Actinic keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents