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COMPLETEDPHASE2

Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick

A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions

NCT02281136•DUSA Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 6 Grade 1/2 AKs on one upper extremity AND
•At least 12 Grade 1/2 AKs on the OTHER 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
•Body Mass Index (BMI) \> 32.0 kg/m2
•skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
•significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
•tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
•a history of lead poisoning or a history of a significant exposure to lead or a screening lead level above 6μg/dl
•tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
•positive drug screen at Screening
+12 more criteria

Locations (3)

Therapeutics Clinical Research

San Diego, California, United States

Shideler Clinical Research Center

Carmel, Indiana, United States

DermResearch, Inc.

Austin, Texas, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

April 1, 2015

Completion Date

April 1, 2015

Last Updated

January 13, 2017

Enrollment

ACTUAL participants

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid (ALA)

DRUG

BLU-U

DEVICE

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Keratosis, Actinic

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COMPLETEDNA

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Keratosis, Actinic

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COMPLETEDPHASE2

Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

NCT01458587

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: January 13, 2017Data 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.

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