DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (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: Keratosis, Actinic

Intervention: Aminolevulinic Acid PDT (ALA) (Drug); Vehicle PDT (VEH) (Drug)

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 PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Clinical Details

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

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

Primary outcome: Lesion Clearance Rate

Secondary outcome:

Lesion Clearance Rate

Complete Clearance Rate

Complete Clearance Rate

Partial Clearance Rate

Partial Clearance Rate

Subject Satisfaction Score

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

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

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

Eligibility

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

Criteria:

Inclusion Criteria:

- At least 4 Grade 1/2 AKs on each upper extremity

Exclusion Criteria:

- Pregnancy

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

photodermatosis

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

skin cancers within the Treatment Area

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

product or requires the use of interfering topical or systemic therapy

- Subject is immunosuppressed

- unsuccessful outcome from previous ALA-PDT therapy

- 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)

- 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

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

Park Avenue Dermatology, PA, Orange Park, Florida 32073, United States

DermResearch, Inc, Austin, Texas 78759, United States

Additional Information

Starting date: November 2011
Last updated: March 12, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017