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

Purpose

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).

Condition	Intervention
Actinic Keratosis	Drug: 5-ALA plus Blu-Light Drug: 5-FU, Imiquimod or treatment with cryotherapy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

Resource links provided by NLM:

Genetics Home Reference related topics: hystrix-like ichthyosis with deafness lamellar ichthyosis nonbullous congenital ichthyosiform erythroderma

Drug Information available for: Fluorouracil Aminolevulinic acid Aminolevulinic acid hydrochloride Imiquimod

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Actinic keratosis /incomplete therapy and reoccurence [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation) [ Time Frame: 2 months -18 months of the follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).	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.
Experimental: 2 5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.	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.

Arms

Assigned Interventions

Experimental: 1

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

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.

Experimental: 2

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814528

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Maria Tsoukas, MD

University of Chicago

More Information

No publications provided

Responsible Party:	Maria Tsoukas, MD - Assistant Professor of Dermatology, The University of Chicago
ClinicalTrials.gov Identifier:	NCT00814528 History of Changes
Other Study ID Numbers:	15725A
Study First Received:	December 23, 2008
Last Updated:	April 20, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

actinic keratosis
skin lesions
5-ALA
AK
Blu-Light

Additional relevant MeSH terms:

Ichthyosis
Keratosis
Keratosis, Actinic
Keratoacanthoma
Skin Diseases
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Aminolevulinic Acid

Imiquimod
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors
Antineoplastic Agents
Interferon Inducers

ClinicalTrials.gov processed this record on May 16, 2013