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Completed

NCT Number: NCT00558688

A Photodynamic Therapy for Treatment of Actinic Keratoses

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photodynamic Therapy

Procedure

Photodynamic therapy applied to actinic keratoses

Primary outcomes

  1. Visual assessment of lesions

    Time frame: 4 weeks

Secondary outcomes

  1. Patient subjective assessment and Safety

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 15, 2007
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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