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

NCT ID: NCT00814528

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-09-30

Brief Summary

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).

Conditions

Actinic Keratosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

5-ALA plus Blu-Light

Intervention Type: DRUG

20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.

2

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

Group Type: EXPERIMENTAL

5-FU, Imiquimod or treatment with cryotherapy

Intervention Type: DRUG

Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.

Interventions

5-ALA plus Blu-Light

20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.

Intervention Type: DRUG

5-FU, Imiquimod or treatment with cryotherapy

Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Tsoukas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

15725A

Identifier Type: -

Identifier Source: org_study_id