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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Ruhr University of Bochum.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Nina Scola, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01481155
First received: November 24, 2011
Last updated: December 7, 2011
Last verified: December 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 Ruhr University of Bochum:

Primary Outcome Measures:
  • Number of actinic keratoses 3 months after treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histologic features [ Time Frame: 1 month after therapy ] [ Designated as safety issue: No ]
  • Epidermal thickness in optical coherence tomography [ Time Frame: 1 month after therapy ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481155

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

No publications provided

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
Study First Received: November 24, 2011
Last Updated: December 7, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
actinic keratosis
field cancerisation

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

ClinicalTrials.gov processed this record on July 24, 2014