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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01481155

Enrollment

Registered

2011-11-29

Start date

2011-03-31

Completion date

Unknown

Last updated

2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

actinic keratosis, field cancerisation

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.

Interventions

PROCEDUREablative CO2 laser therapy

CO2 laser therapy

PROCEDUREphotodynamic therapy

Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of actinic keratoses 3 months after treatment	3 months

Secondary

Measure	Time frame
Histologic features	1 month after therapy
Epidermal thickness in optical coherence tomography	1 month after therapy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026