Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

The University of Chicago

Status: Withdrawn

Conditions: Actinic Keratosis

Treatments: Drug: 5-ALA plus Blu-Light; Drug: 5-FU, Imiquimod or treatment with cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00814528

15725A

Details and patient eligibility

About

The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-95 years old
• Diagnosied with actinic keratoses.

Exclusion criteria

• Patients who have had Isotretinoin therapy less that 1 year prior to screening.
• Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
• History of porphyria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Description:

Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).

Treatment:

Drug: 5-ALA plus Blu-Light

2

Experimental group

Description:

5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.

Treatment:

Drug: 5-FU, Imiquimod or treatment with cryotherapy