Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses

NCT ID: NCT01481155

Last Updated: 2011-12-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects.

Detailed Description

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Ablative laser therapy and photodynamic therapy are widely used and accepted therapeutic methods to treat multiple actinic keratoses, yet comparative studies are rare. The purpose of this study is to compare both treatments intraindividually with respect to treatment efficacy and side effects.

Conditions

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Actinic Keratosis

Keywords

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actinic keratosis field cancerisation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

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ablative CO2 laser therapy

CO2 laser therapy

Intervention Type PROCEDURE

photodynamic therapy

Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* men and women with clinical and histological diagnosed, symmetrical distributed actinic keratoses
* at least 2 actinic keratoses, on each of both treatment areas at least one
* Patients must be 18 years or older.

Exclusion Criteria

* Age 17 years or younger
* lack of patient's informed consent for any of the two treatments
* contraindication for Co2 therapy or for photodynamic therapy
* skin infection in the treatment area
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nina Scola

Dr. med. Nina Scola, consultant in Ruhr University of Bochum

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Dermatology, Venereology and Allergology, Ruhr University

Bochum, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PDT vs. CO2

Identifier Type: -

Identifier Source: org_study_id