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

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00814528
• Other study ID #: 15725A
• Status: Withdrawn
• Phase: N/A
• Start date: November 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actinic keratosis /incomplete therapy and reoccurence		18 months
Secondary	Erythema	Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)	2 weeks post therapy