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

November 24, 2011
December 7, 2011
March 2011
December 2011   (final data collection date for primary outcome measure)
Number of actinic keratoses 3 months after treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01481155 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Actinic Keratosis
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01481155
PDT vs. CO2
Not Provided
Dr. Nina Scola, Ruhr University of Bochum
Ruhr University of Bochum
Not Provided
Not Provided
Ruhr University of Bochum
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP