We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Dr. Nina Scola, Ruhr University of Bochum.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01481155
First Posted: November 29, 2011
Last Update Posted: December 8, 2011
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.
Information provided by (Responsible Party):
Dr. Nina Scola, Ruhr University of Bochum
  Purpose
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 Intervention
Actinic Keratosis Procedure: ablative CO2 laser therapy Procedure: photodynamic therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Nina Scola, Ruhr University of Bochum:

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

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

Enrollment: 21
Study Start Date: March 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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
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.
  Eligibility

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 Submitted: November 24, 2011
First Posted: November 29, 2011
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