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

Not Applicable

• Conditions: Actinic Keratosis

• Registration Number: NCT01481155
• Lead Sponsor: Ruhr University of Bochum

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-24
• Study First Posted: 2011-11-29
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of actinic keratoses 3 months after treatment	3 months

Secondary Outcome Measures

Name	Time	Method
Histologic features	1 month after therapy
Epidermal thickness in optical coherence tomography	1 month after therapy

Trial Locations

Locations (1)

Department of Dermatology, Venereology and Allergology, Ruhr University; 🇩🇪 Bochum, Germany