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A Photodynamic Therapy for Treatment of Actinic Keratoses


N/A
18 Years
90 Years
Not Enrolling
Both
Actinic Keratoses

Thank you

Trial Information

A Photodynamic Therapy for Treatment of Actinic Keratoses


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Visual assessment of lesions

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Murad Alam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

STU00000312

NCT ID:

NCT00558688

Start Date:

August 2007

Completion Date:

August 2009

Related Keywords:

  • Actinic Keratoses
  • Keratosis
  • Keratosis, Actinic

Name

Location

Northwestern University Department of Dermatology Chicago, Illinois  60611