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Keratosis, Actinic

Keratosis

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Aminolevulinic Acid

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VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Broad Area ALA 1-hour incubation

Broad Area ALA 2 hour incubation

broad area ALA 3-hour incubation

Spot ALA 2 hour incubation

Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Vehicle PDT

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

Blue Light Treatment

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 keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp

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

the proportion of subjects in each treatment group 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.

AK Clearance Rate (AKCR) for a subject is defined as:

100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]

0 = no improvement or worsening (not satisfied at all)

1. = slight improvement (slightly satisfied)
2. = moderate improvement (moderately satisfied)
3. = excellent improvement (very satisfied)

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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

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.

Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation

Broad Area ALA 1-hour

Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation

Broad Area ALA 2-hour

broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation

Broad Area ALA 3-hour

Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation

Spot ALA 2-hour

VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5

Broad Area ALA 1-hour + BLUE Light Treatment

Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5

Broad Area ALA 2-hour + BLUE Light Treatment

broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5

Broad Area ALA 3-hour + BLUE Light Treatment

Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5

Spot ALA 2-hour + BLUE Light Treatment

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

Vehicle (VEH) + BLUE Light Treatment

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Manager of Clinical Studies

Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.

Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.

broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.

Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

Vehicle + BLUE Light Treatment

Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data

Complete Clearance Rate

Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation,prior to BLUE light treatment at Visits 1 and 5.

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. . Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

Partial Clearance Rate

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group were randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

AK Clearance Rate

Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5

Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5

broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5

Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment, at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Vist 1 and Visit 5

broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5

Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5

VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5 . Subjects receiving VEH were considered a single treatment group.

Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

3 = excellent improvement (very satisfied)

2 = moderate improvement (moderately satisfied)

1 = slight improvement (slightly satisfied)

0 = no improvement or worsening (not satisfied at

Subject Satisfaction Score

Grade 0 - None

Grade 1 - Light

Grade 2 - Moderate/small

Grade 3 - Moderate/moderate

Hyperpigmentation at Baseline

Hyperpigmentation at Visit 2

Hyperpigmentation at Visit 3

Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

Hyperpigmentation at Visit 4

Hyperpigmentation at Visit 5

Hyperpigmentation at Visit 6

Grade 4 - Marked

Hyperpigmentation at Visit 7

Hypopigmentation at Baseline

Hypopigmentation at Visit 2

Hypopigmentation at Visit 3

Grade - None

Hypopigmentation at Visit 4

Hypopigmentation at Visit 5

Hypopigmentation at Visit 6

Hypopigmentation at Visit 7

Grade 1 - Minimal

Grade 2 Mild

Grade 3 - Moderate

Erythema at Baseline

Grade 4 - Severe

Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5

Erythema Post-Light Treatment

Erythema at Visit 2

Erythema at Visit 3

Erythema at Visit 4

Erythema at Visit 5 (Pre-drug)

Erythema at Visit 5 (Post-light)

Erythema at Visit 6

Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi

Erythema at Visit 7

Grade 2 - Mild

Edema at Baseline

Edema Post-Light Treatment

Edema at Visit 2

Edema at Visit 3

Edema at Visit 4

Edema at Visit 5 (Pre-drug)

Edema Post PDT #2

Edema at Week 12

Edema at Week 24

Grade 1 - MInimal

Grade 2 - Moderate

Grade 3 - Severe

Stinging/Burning at Baseline

Stinging/Burning During Light Treatment

Stinging/Burning Post Light-Treatment

Stinging/Burning at Visit 2

Stinging/Burning at Visit 3

Stinging/Burning at Visit 4

Stinging/Burning at Visit 5 (Pre-drug)

Stinging/Burning at Visit 5 During PDT#2

Stinging/Burning at Visit 5 Post PDT#2

Stinging/Burning at Visit 6

Stinging/Burning at Visit 7

Scaling and Dryness at Baseline

Scaling and Dryness at Visit 2

Scaling and Dryness at Visit 3

Scaling and Dryness at Visit 4

Scaling and Dryness at Visit 5

Scaling and Dryness at Visit 6

Scaling and Dryness at Visit 7

Oozing/Vesiculation/Crusting at Baseline

Oozing/Vesiculation/Crusting at Visit 2

Oozing/Vesiculation/Crusting at Visit 3

Oozing/Vesiculation/Crusting at Visit 4

Oozing/Vesiculation/Crusting at Visit 5

Oozing/Vesiculation/Crusting at Visit 6

Oozing/Vesiculation/Crusting at Visit 7

Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5

Vehicle (VEH) group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.

Vehicle (VEH) Photodynamic Therapy (PDT) : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)	NCT01475955	Actinic Keratos...	Broad Area ALA ... Broad Area ALA ... broad area ALA ... Spot ALA 2 hour... Vehicle PDT Blue Light Trea...	18 Years -	DUSA Pharmaceuticals, Inc.
Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)	NCT01475955	Actinic Keratos...	Broad Area ALA ... Broad Area ALA ... broad area ALA ... Spot ALA 2 hour... Vehicle PDT Blue Light Trea...	18 Years -	DUSA Pharmaceuticals, Inc.

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