A Photodynamic Therapy for Treatment of Actinic Keratoses

NCT ID: NCT00558688

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.

Detailed Description

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This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses

Conditions

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Actinic Keratoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Light Therapy

Group Type EXPERIMENTAL

Photodynamic therapy

Intervention Type PROCEDURE

Photodynamic therapy applied to actinic keratoses

2

Light Therapy

Group Type EXPERIMENTAL

Photodynamic therapy

Intervention Type PROCEDURE

Photodynamic therapy applied to actinic keratoses

Interventions

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Photodynamic therapy

Photodynamic therapy applied to actinic keratoses

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age greater than or equal to 18 years

* Have a t least 4 nonhypertrophic AK lesions on the body
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator

Exclusion Criteria

* Subjects who are pregnant or lactating
* Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
* Subjects with use of photosensitizing drugs within 1 week of study start
* Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
* Subjects with systemic steroid therapy within 4 weeks before study entry
* Subjects who received previous treatment of target AKs
* Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry
* Subjects with prior history of hypersensitivity reactions to lidocaine
* Subjects who are unable to understand the protocol or to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00000312

Identifier Type: -

Identifier Source: org_study_id