Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Pharmaceutical Solutions

All Drugs and Chemicals

Dermatologic Agents

Aminolevulinic Acid

Photosensitizing Agents

Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments

Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.

Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments

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

Topical Solution Vehicle

10 J/cm2 blue light delivered at 10 mW/cm2

BLU-U

Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Cryotherapy

Stuart Marcus, MD, PhD

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.

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light

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 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

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 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 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

Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.

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 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 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

Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.

Normalized based on number of lesions present at Baseline

Subject satisfaction score

1. = Excellent (very satisfied)
2. = Good (moderately satisfied)
3. = Fair (slightly satisfied)
4. = Poor (not satisfied at all) Unknown

Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).

Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first

DUSA Pharmaceuticals, Inc.

Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments

Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2

Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.

ALA X2

Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments

Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2

Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.

ALA X3

Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.

Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2

Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.

VEH-PDT

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Fitzpatrick Skin Type staging:

Skin Type I - Burns easily, never tans Skin Type II - Burns easily, tans minimally Skin Type III - Burns moderately, tans gradually Skin Type IV - Burns minimally, tans well Skin Type V - Rarely burns, tans profusely

Skin Type

Anna Houlihan

Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.

Total Number of AKs in Treatment Area

Analysis population consisted of observed data; ie. subjects with data at Week 4.

Proportion of Subjects With 0 AKs

Subject Satisfaction Score

Analysis population consisted of observed data; ie. subjects with data at Week 12.

Analysis population consisted of observed data only.

Analysis population consisted of observed data only

Recurrence Rate

Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.

Duration of Response

Hyperpigmentation

Hypopigmentation

Erythema

Edema

Stinging/Burning

Scaling & Dryness

Oozing/Vesiculation/Crusting

Cryotherapy followed by 2 aminolevulinic acid + blue light (BLU-U) treatments

Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2

Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments

Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2

Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.

Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.

Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2

Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.

Spots Global Cancer Trial Database for Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

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Study Description

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