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A Photodynamic Therapy for Treatment of Actinic Keratoses

Northwestern University logo

Northwestern University

Status

Completed

Conditions

Actinic Keratoses

Treatments

Procedure: Photodynamic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00558688
STU00000312

Details and patient eligibility

About

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.

Full 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

Enrollment

20 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

20 participants in 2 patient groups

1
Experimental group
Description:
Light Therapy
Treatment:
Procedure: Photodynamic therapy
2
Experimental group
Description:
Light Therapy
Treatment:
Procedure: Photodynamic therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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