We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01481155
Recruitment Status : Unknown
Verified December 2011 by Dr. Nina Scola, Ruhr University of Bochum.
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2011
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Actinic Keratosis Procedure: ablative CO2 laser therapy Procedure: photodynamic therapy

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
Study Start Date : March 2011
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: ablative CO2 laser therapy
    CO2 laser therapy
    Procedure: photodynamic therapy
    Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²

Outcome Measures

Primary Outcome Measures :
  1. Number of actinic keratoses 3 months after treatment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Histologic features [ Time Frame: 1 month after therapy ]
  2. Epidermal thickness in optical coherence tomography [ Time Frame: 1 month after therapy ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481155


Locations
Germany
Department of Dermatology, Venereology and Allergology, Ruhr University
Bochum, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
More Information

Responsible Party: Dr. Nina Scola, Dr. med. Nina Scola, consultant in Ruhr University of Bochum, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01481155     History of Changes
Other Study ID Numbers: PDT vs. CO2
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Dr. Nina Scola, Ruhr University of Bochum:
actinic keratosis
field cancerisation

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms