Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
18 Years
N/A
Both
Actinic Keratosis
Trial Information
Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Number of actinic keratoses 3 months after treatment
Outcome Time Frame:
3 months
Safety Issue:
No
Authority:
Germany: Ethics Commission
Study ID:
PDT vs. CO2
NCT ID:
NCT01481155
Start Date:
March 2011
Completion Date:
Related Keywords:
- Actinic Keratosis
- actinic keratosis
- field cancerisation
- Keratosis
- Keratosis, Actinic
- Ichthyosis
- Keratoacanthoma
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