Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Pharmaceutical Solutions

All Drugs and Chemicals

Dermatologic Agents

Aminolevulinic Acid

Photosensitizing Agents

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

Aminolevulinic Acid (ALA)

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

Topical Solution Vehicle

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

Blue Light Photodynamic Therapy Illuminator (BLU-U)

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 on the upper arms and hands

Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities

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 Grade 4 = Marked hypopigmentation involving moderate or large sized areas

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

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

proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100

Subject satisfaction score

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

DUSA Pharmaceuticals, Inc.

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

BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2

ALA-PDT

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 Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2

Vehicle

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Type I

Type II

Type III

Type IV

Type V

Type VI

Fitzpatrick Skin Type I - Always burns easily; never tans (sensitive) II - Always burns easily; tans minimally (sensitive) III - Burns moderately; tans gradually (light brown) (normal) IV - Burns minimally, always tans well (moderate brown) (normal) V - Rarely burns; tans profusely (dark brown) (insensitive) VI - Never burns; deeply pigmented (insensitive)

Skin Type

Total Number AK Lesions (Grade 1/2)

Anna Houlihan

A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.

Spots Global Cancer Trial Database for Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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