Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Actinic Keratosis Clinical Trial

Official title:

UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327831
• Other study ID #: 2015-1889
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2015
• Last updated: December 13, 2017
• Start date: April 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.

Description:

• Initial Visit:

• study inclusion criteria reviewed

• consent forms reviewed

• creation of facial map for actinic keratoses

• face cleansed with chlorhexidine soap

• light curettage of precancerous skin lesions

• application of topical aminolevulinic acid (ALA)

• application of sunscreen

• patient then spends 2 hours outdoors in a shaded area

• after treatment the patient is to remain indoors for 48 hours

• 3 month follow up visit

• facial map of actinic keratoses used to document treatment response

• 6 month follow up visit

• facial map of actinic keratoses used to document treatment response

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of >10 actinic keratoses on head and neck

• Age = 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study)

• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Patients currently undergoing anti-neoplastic therapy including but not limited to the following:

• Topical imiquimod

• Topical 5-fluorouracil

• Topical ingenol mebutate

• Topical diclofenac

• Topical retinoids

• Oral acitretin

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid

• Patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease.

• Patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines.

• pregnancy

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Aminolevulinic Acid
Topical application followed by activation by ambient sunlight

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the number of Actinic Keratoses	The the change in number of actinic keratoses at time 0 and 6 months treatment will be measured as the primary outcome	0, 3, and 6 months
Secondary	Adverse events	Measurement of crusting, erythema, edema, and pain	0, 3, and 6 months
Secondary	Lux Correlation	Ambient lux from sunlight is measured during treatment and will be analyzed to determine if it contributes to treatment efficacy	0, 3, and 6 months