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

Actinic Keratosis Clinical Trial

Official title:

Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01481155
• Other study ID #: PDT vs. CO2
• Status: Active, not recruiting
• Phase: N/A
• First received: November 24, 2011
• Last updated: December 7, 2011
• Start date: March 2011

Study information

• Verified date: December 2011
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Procedure:
• ablative CO2 laser therapy
CO2 laser therapy
• photodynamic therapy
Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²

Locations

Country	Name	City	State
Germany	Department of Dermatology, Venereology and Allergology, Ruhr University	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of actinic keratoses 3 months after treatment		3 months	No
Secondary	Histologic features		1 month after therapy	No
Secondary	Epidermal thickness in optical coherence tomography		1 month after therapy	No