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 PDT (ALA)

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

Vehicle PDT (VEH)

Stuart Marcus, MD, PhD

The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities

proportion of subjects with a count of zero lesions in the treatment area

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.

Subject satisfaction score

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

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

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

DUSA Pharmaceuticals, Inc.

ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.

Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.

Vehicle

Total

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Anna Houlihan

ALA application on one extremity occluded with plastic wrap during the incubation period.

ALA+OCC

ALA application on one extremity unoccluded during the incubation period.

ALA-OCC

Vehicle application on one extremity occluded with plastic wrap during the incubation period.

VEH+OCC

Vehicle application on one extremity unoccluded during the incubation period.

VEH-OCC

Lesion Clearance Rate

Complete Clearance Rate

Partial Clearance Rate

Very satisfied

Moderately satisfied

Slightly satisfied

Not satisfied

Subject Satisfaction Score

Grade 0 (none)

Grade 1 (light)

Grade 2 (moderate - small)

Grade 3 (moderate - moderate)

Hyperpigmentation at Baseline

Hyperpigmentation at Visit 3

Hyperpigmentation at Visit 4

Hyperpigmentation at Visit 5

Hypopigmentation at Baseline

Hypopigmentation at Visit 3

Hypopigmentation at Visit 4

Hypopigmentation at Visit 5

Grade 1 (minimal)

Grade 2 (mild)

Grade 3 (moderate)

Grade 4 (severe)

Erythema at Baseline

Erythema Post-Light Treatment

Erythema at Visit 3

Erythema at Visit 4

Erythema at Visit 5

Edema at Baseline

Edema Post-Light Treatment

Edema at Visit 3

Edema at Visit 4

Edema at Visit 5

Grade 1 (mild)

Grade 2 (moderate)

Grade 3 (severe)

Stinging/Burning at Baseline

Stinging/Burning During Light Treatment

Stinging/Burning Post Light Treatment

Stinging/Burning at Visit 3

Stinging/Burning at Visit 4

Stinging/Burning at Visit 5

Scaling and Dryness at Baseline

Scaling and Dryness at Visit 3

Scaling and Dryness at Visit 4

Scaling and Dryness at Visit 5

OOZING/VESICULATION/CRUSTING at Baseline

OOZING/VESICULATION/CRUSTING at Visit 3

OOZING/VESICULATION/CRUSTING at Visit 4

OOZING/VESICULATION/CRUSTING at Visit 5

Overall Study

Spots Global Cancer Trial Database for Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial