A Photodynamic Therapy for Treatment of Actinic Keratoses

Not Applicable

Completed

• Conditions: Actinic Keratoses
• Interventions: Procedure: Photodynamic therapy

• Registration Number: NCT00558688
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.

Detailed Description

This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-15
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age greater than or equal to 18 years

• Have a t least 4 nonhypertrophic AK lesions on the body
• The subjects are in good health
• The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator

Exclusion Criteria

• Subjects who are pregnant or lactating
• Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
• Subjects with use of photosensitizing drugs within 1 week of study start
• Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
• Subjects with systemic steroid therapy within 4 weeks before study entry
• Subjects who received previous treatment of target AKs
• Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry
• Subjects with prior history of hypersensitivity reactions to lidocaine
• Subjects who are unable to understand the protocol or to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Photodynamic therapy	Light Therapy
2	Photodynamic therapy	Light Therapy

Primary Outcome Measures

Name	Time	Method
Visual assessment of lesions	4 weeks

Secondary Outcome Measures

Name	Time	Method
Patient subjective assessment and Safety	4 weeks

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States