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Trial record 8 of 780 for:    ALA

MUSE Study of Levulan Kerastick

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by DUSA Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02281136
First received: October 30, 2014
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Keratosis, Actinic
Drug: Aminolevulinic Acid (ALA)
Device: BLU-U
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions

Resource links provided by NLM:


Further study details as provided by DUSA Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) for ALA [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Maximum observed plasma concentration (Cmax) for ALA over the 24 hour sampling time period based on actual values measured. Blood samples will taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.

  • Time at which Cmax is attained (Tmax) for ALA [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Time at which Cmax is attained (Tmax) 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.

  • Area under the plasma concentration versus time curve from time zero to time tlast (time of last observed quantifiable concentration; AUC0-tlast) and AUC0-∞ (if T1/2,z can be estimated) for ALA. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The area under the plasma concentration-time curve (AUC0-tlast) from time zero to the time of the last observed quantifiable plasma sample (tlast) will be calculated by the linear trapezoidal rule. The AUC from tlast to time infinity (AUCtlast-inf) will be calculated as the observed plasma concentration at tlast divided by the absolute value of slope (if t1/2,z can be determined). The total AUC from time zero to infinity (AUC0-inf) will be calculated as the sum of AUC0-tlast and AUCtlast-inf

  • The terminal exponential half-life (T1/2,z) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • Hyperpigmentation [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • Hyperpigmentation [ Time Frame: 24 hours after PDT ] [ Designated as safety issue: Yes ]
    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

  • Hyperpigmentation [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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

  • Hypopigmentation [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • Hypopigmentation [ Time Frame: 24 hours after PDT ] [ Designated as safety issue: Yes ]
    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

  • Hypopigmentation [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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

  • Erythema [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • Erythema [ Time Frame: 5 Minutes after PDT ] [ Designated as safety issue: Yes ]
    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

  • Erythema [ Time Frame: 24 hours after PDT ] [ Designated as safety issue: Yes ]
    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

  • Erythema [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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

  • Edema [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • Edema [ Time Frame: 5 Minutes after PDT ] [ Designated as safety issue: Yes ]
    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

  • Edema [ Time Frame: 24 hours after PDT ] [ Designated as safety issue: Yes ]
    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

  • Edema [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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

  • Stinging/Burning [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • Stinging/Burning [ Time Frame: During PDT ] [ Designated as safety issue: Yes ]
    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

  • Stinging/Burning [ Time Frame: 5 Minutes after PDT ] [ Designated as safety issue: Yes ]
    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

  • Stinging/Burning [ Time Frame: 24 hours after PDT ] [ Designated as safety issue: Yes ]
    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

  • Stinging/Burning [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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

  • Scaling and Dryness [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • Scaling and Dryness at Visit 4 [ Time Frame: 24 hours after PDT ] [ Designated as safety issue: Yes ]
    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

  • Scaling and Dryness [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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

  • OOZING/VESICULATION/CRUSTING [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • OOZING/VESICULATION/CRUSTING [ Time Frame: 24 hours after PDT ] [ Designated as safety issue: Yes ]
    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

  • OOZING/VESICULATION/CRUSTING [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 25
Study Start Date: December 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02281136

Contacts
Contact: Jim Berg 858-571-1800 ext 131 jberg@therapeuticsinc.com
Contact: Dan Piacquadio, MD 858-571-1800 ext 107 danp@therapeuticsinc.com

Locations
United States, California
Therapeutics Clinical Research Not yet recruiting
San Diego, California, United States, 92123
Contact: Kim Cruz    858-571-6800      
Principal Investigator: Neal Bhatia, MD         
United States, Indiana
Shideler Clinical Research Center Not yet recruiting
Carmel, Indiana, United States, 46032
Contact: Denise Rody    317-819-1268    drody@shideler.com   
Principal Investigator: Stephen Shideler, MD         
United States, Texas
DermResearch, Inc. Not yet recruiting
Austin, Texas, United States, 78759
Contact: Diana Garner    512-349-9889    dgarner@dermresearch.net   
Principal Investigator: Janet DuBois, MD         
Sponsors and Collaborators
DUSA Pharmaceuticals, Inc.
Investigators
Study Director: Stuart Marcus, MD, PhD DUSA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02281136     History of Changes
Other Study ID Numbers: CP0110
Study First Received: October 30, 2014
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DUSA Pharmaceuticals, Inc.:
Actinic keratosis

Additional relevant MeSH terms:
Aminolevulinic Acid
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014