Back to resultsComparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
Primary Purpose
Actinic Keratosis
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ablative CO2 laser therapy
photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring actinic keratosis, field cancerisation
Eligibility 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
Sites / Locations
- Department of Dermatology, Venereology and Allergology, Ruhr University
Outcomes
Primary Outcome Measures
Number of actinic keratoses 3 months after treatment
Secondary Outcome Measures
Histologic features
Epidermal thickness in optical coherence tomography
Full Information
NCT ID
NCT01481155
First Posted
November 24, 2011
Last Updated
December 7, 2011
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT01481155
Brief Title
Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
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 Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
actinic keratosis, field cancerisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ablative CO2 laser therapy
Intervention Description
CO2 laser therapy
Intervention Type
Procedure
Intervention Name(s)
photodynamic therapy
Intervention Description
Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²
Primary Outcome Measure Information:
Title
Number of actinic keratoses 3 months after treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Histologic features
Time Frame
1 month after therapy
Title
Epidermal thickness in optical coherence tomography
Time Frame
1 month after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Dermatology, Venereology and Allergology, Ruhr University
City
Bochum
ZIP/Postal Code
44791
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
We'll reach out to this number within 24 hrs