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COMPLETEDPHASE2

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light

NCT02239679•DUSA Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Four to fifteen AKs on the face
•histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
•at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years

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)
•has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
+5 more criteria

Locations (8)

UCSD Dermatology

San Diego, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Shideler Clinical Research Center

Carmel, Indiana, United States

Sadick Research Group

New York, New York, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Suzanne Bruce and Associates, P.A.,The Center for Skin Research

Houston, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

July 1, 2016

Completion Date

September 1, 2016

Last Updated

August 24, 2018

Enrollment

166

ACTUAL participants

Conditions

Actinic Keratosis

Interventions

Aminolevulinic Acid

DRUG

Topical Solution Vehicle

DRUG

BLU-U

DEVICE

Cryotherapy

PROCEDURE

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

NCT06778434

Actinic KeratosisImipramine+1 more

View study

RECRUITING

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

NCT06648447

Actinic Keratosis (AK)

View study

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: August 24, 2018Data 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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Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

Inclusion Criteria

Exclusion Criteria

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Trial to Investigate GZ21T in Healthy Volunteers

Indoor Daylight Photodynamic Therapy is an Effective, First-line Treatment for AK, But Its Feasibility is Limited by the Time Required for the Illumination (2 Hours). Our Objective Was to Evaluate the Efficacy of Idl-PDT With an Illumination Time of 1 Hour Versus 2 Hours in the Treatment of Scalp AK

Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis