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Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01458587•DUSA Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+6 more criteria

Locations (3)

Therapeutics Clinical Research

San Diego, California, United States

Park Avenue Dermatology, PA

Orange Park, Florida, United States

DermResearch, Inc

Austin, Texas, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

March 14, 2013

Enrollment

ACTUAL participants

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid PDT (ALA)

DRUG

Vehicle PDT (VEH)

DRUG

A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

NCT05279131

Keratosis, Actinic

View study

COMPLETEDNA

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

NCT02594644

Keratosis, Actinic

View study

COMPLETEDPHASE2

Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick

NCT02281136

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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