After the surgical excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment.

Subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours. At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals). Lastly, they will be asked to fill out a satisfaction survey.

Squamous Cell Carcinoma

Intervention group subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours.

Levulan Kerastick

At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals).

blue light source

Participants will be asked to fill out a satisfaction survey.

participant satisfaction survey

Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ

After the excision, investigators will collect patient satisfaction data. Investigators will also review the final pathology report for presence or absence of the tumor.

The subjects will be monitored for any side effects, such as erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after treatment.

Rhode Island Hospital

DUSA Pharmaceuticals, Inc.

Treatment 1 will include microneedling performed prior to ALA application to their right face and ALA application only to the left face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds).

Treatment 2 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds).

Treatment 3 will include microneedling performed prior to ALA application to their right face and ALA application only to the left side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds).

Treatment 4 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds).

Actinic Keratoses

Aminolevulinic Acid (ALA)

Environ Cosmetic Roller

BLU-U IIlluminator

Dermatology, Laser & Vein Specialists of the Carolinas

Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times

A Randomized, Evaluator-blinded, Bilateral Comparison of the Treatment of Facial Actinic Keratoses Using Combination Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Different Incubation Times

Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)

Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)

Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)

Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)

ALA 1000 Seconds

ALA 500 Seconds

Vehicle 1000 Seconds

Vehicle 500 Seconds

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Edema

Erythema

Fitzpatrick Skin Type

Hyperpigmentation

Hypopigmentation

Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions)

Investigator Global Assessment of Acne Severity

Oozing/vesiculation.crusting

Scaling and Dryness

Stinging/Burning

Number of Inflammatory Lesions

Change in Inflammatory Lesion Counts Relative to Baseline

Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.

Investigator Global Assessment of Acne Severity Successes

Percent Change in Inflammatory Lesion Counts Relative to Baseline

Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all)

Subject Satisfaction Score

change in lesion counts compared to baseline

Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.
0 Clear skin with no inflam or non-inflam lesions
Almost clear; rare non-inflam lesions with no more than a few small inflam lesions
Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)
Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule
Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules

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 48 Hours After PDT #1

Hyperpigmentation at Visit 3 (Week 3)

Hyperpigmentation at Visit 5 (Week 6)

Hyperpigmentation at Visit 7 (Week 9)

Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)

Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)

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 48 Hours Post PDT #1

Hypopigmentation at Visit 3 (Week 3)

Hypopigmentation at Visit 5 (Week 6)

Hypopigmentation at Visit 7 (Week 9)

Hypopigmentation at Visit 9 (3 Weeks After Final PDT)

Hypopigmentation at Visit 10 (6 Weeks After Final PDT)

After solution application, prior to light treatment
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 at Baseline (Pre-light)

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 at Baseline - Post Light Treatment

Erythema 48 Hours After PDT #1

Erythema at Visit 3 (Week 3 - Pre Study Drug Application)

Erythema at Visit 3 (Week 3 - Pre-light)

Erythema at Visit 3 (Week 3 - Post Light Treatment)

Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)

Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)

Erythema at Visit 5 (Week 6 - Post Light Treatment)

Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)

Erythema at Visit 7 (Week 9 - Pre Light Treatment)

Erythema at Visit 7 (Week 9 - Post Light Treatment)

Erythema 3 Weeks After Final PDT

Erythema 6 Weeks After Final PDT

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 at Baseline - Pre Light Treatment

Edema at Baseline - Post Light Treatment

Edema 48 Hours After PDT #1

Edema at Visit 3 (Week 3 - Before Study Drug Application)

Edema at Visit 3 (Week 3 - Before Light Treatment)

Edema at Visit 3 (Week 3 - Post Light Treatment)

Edema at Visit 5 (Week 6 - Before Study Drug Application)

Edema at Visit 5 (Week 6 - Pre Light Treatment)

Edema at Visit 5 (Week 6 - Post Light Treatment)

Edema at Visit 7 (Week 9 - Before Study Drug Application)

Edema at Visit 7 (Week 9 - Prior to Light Treatment)

Edema at Visit 7 (Week 9 - Post Light Treatment)

Edema 3 Weeks After Final PDT

Edema 6 Weeks After Final PDT

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 at Baseline - Before Light Treatment

Stinging/Burning at Baseline - During Light

Stinging/Burning at Baseline - Post Light Treatment

Stinging/Burning 48 Hours Post PDT #1

Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)

Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)

Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)

Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)

Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)

Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)

Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)

Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)

Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)

Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)

Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)

Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)

Stinging/Burning at Visit 9 (3 Weeks After Final PDT)

Stinging/Burning at Visit 10 (6 Weeks After Final PDT)

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 48 Hours After PDT #1

Scaling and Dryness at Visit 3 (Week 3)

Scaling and Dryness at Visit 5 (Week 6)

Scaling and Dryness at Visit 7 (Week 9)

Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)

Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)

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 48 Hours After PDT #1

Oozing/Vesiculation/Crusting at Visit 3 (Week 3)

Oozing/Vesiculation/Crusting at Visit 5 (Week 6)

Oozing/Vesiculation/Crusting at Visit 7 (Week 9)

Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)

Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)

Overall Study

Anna Houlihan

Acne Vulgaris

Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.

aminolevulinic acid HCL (ALA)

Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.

Vehicle (VEH)

Burke Pharmaceutical Research

Therapeutics Clinical Research

Cherry Creek Research, Inc.

Kenneth R. Beer, M.D. P.A.

Gwinnett Clinical Research Center, Inc.

Laser and Skin Surger Center of Indiana

Derm Research PLLC

Minnesota Clinical Study Center

Downstate Med Ctr

Penn State Milton S. Hershey Medical Center

Tennessee Clinical Research Center

Derm Research Inc

Baylor Research Institute

Dermatology Research Center, Inc.

Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne

A Randomized, Evaluator-blinded, Parallel Group Light Dose Ranging Study of Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Levulan Topical Solution Vehicle + Blue Light on Moderate to Severe Facial Acne Vulgaris