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

Information source: DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Actinic Keratosis

Intervention: Broad Area ALA 1-hour incubation (Drug); Broad Area ALA 2 hour incubation (Drug); broad area ALA 3-hour incubation (Drug); Spot ALA 2 hour incubation (Drug); Vehicle PDT (Drug); Blue Light Treatment (Device)

Phase: Phase 2

Status: Completed

Sponsored by: DUSA Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Stuart Marcus, MD, PhD, Study Director, Affiliation: DUSA Pharmaceuticals, Inc.

Summary

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.

Clinical Details

Official title: A Phase II Study of Photodynamic Therapy With LEVULANŽ Topical Solution + Blue Light Versus LEVULANŽ 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Complete Clearance Rate

Secondary outcome:

Complete Clearance Rate

Complete Clearance Rate

Complete Clearance Rate

Partial Clearance Rate

Partial Clearance Rate

Partial Clearance Rate

Partial Clearance Rate

AK Clearance Rate

AK Clearance Rate

AK Clearance Rate

AK Clearance Rate

Subject Satisfaction Score

Hyperpigmentation at Baseline

Hyperpigmentation at Visit 2

Hyperpigmentation at Visit 3

Hyperpigmentation at Visit 4

Hyperpigmentation at Visit 5

Hyperpigmentation at Visit 6

Hyperpigmentation at Visit 7

Hypopigmentation at Baseline

Hypopigmentation at Visit 2

Hypopigmentation at Visit 3

Hypopigmentation at Visit 4

Hypopigmentation at Visit 5

Hypopigmentation at Visit 6

Hypopigmentation at Visit 7

Erythema at Baseline

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

Erythema at Visit 7

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 6-20 Grade 1/2 AKs on the face or scalp

- a history of AK therapy within the treatment area at least twice in the two years

prior to study entry Exclusion Criteria:

- Pregnancy

- Grade 3 AKs or atypical AKs (e. g., AK > 1 cm2 in size) within the Treatment Area

- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated

skin cancers within the Treatment Area

- plans to be exposed to artificial tanning devices or excessive sunlight during the

trial

- Subject is immunosuppressed

- unsuccessful outcome from previous ALA-PDT therapy

- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or

photodermatosis

- skin pathology or condition which could interfere with the evaluation of the test

product or requires the use of interfering topical or systemic therapy

- skin pathology or condition that could interfere with the evaluation of the test

product or requires the use of interfering topical or systemic therapy

- any condition which would make it unsafe for the subject to participate in this

research study

- currently enrolled in an investigational drug or device study

- has received an investigational drug or been treated with an investigational device

within 30 days prior to the initiation of treatment

- known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl

alcohol, laureth 4, polyethylene glycol)

- Subject has;

- an active herpes simplex infection OR

- a history of 2 or more outbreaks within the past 12 months, in the Treatment

Area

- use of the following topical preparations on the extremities to be treated:

- Keratolytics including urea (greater than 5%), alpha hydroxyacids [e. g.glycolic

acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.

- Cryotherapy within 2 weeks of initiation of treatment

- Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks

of initiation of treatment.

- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU,

diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.

- Two or more ALA PDT treatments in the past 6 months

- use of systemic retinoid therapy within 6 months of initiation of treatment.

Locations and Contacts

UCSD Dermatology Perlman Ambulatory Clinic, La Jolla, California 92037, United States

Dermatology Research Associates, Los Angeles, California 90045, United States

Therapeutics Clinical Research, San Diego, California 92123, United States

Northwest Clinical Trials, Inc., Boise, Idaho 83704, United States

Altman Dermatology Associates, Arlington Heights, Illinois 60005, United States

The Indiana Clinical Trials Center, PC, Plainfield, Indiana 46168, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Dermatology Research Center of Cincinnati, Cincinnati, Ohio 45220, United States

Oregon Medical Research Center, PC, Portland, Oregon 97223, United States

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States

DermResearch, Inc., Austin, Texas 78759, United States

Suzanne Bruce and Associates, P.A.,The Center for Skin Research, Houston, Texas 77056, United States

Virginia Clinical Research Inc, Norfolk, Virginia 23507, United States

Additional Information

Starting date: December 2011
Last updated: November 26, 2013

Page last updated: August 23, 2015

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