Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Phase 4

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Aminolevulinic Acid

• Registration Number: NCT03327831
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-10-23
• Primary Completion: 2017-02
• Study Completion: 2017-07
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Results First Submitted: 2018-10-30
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Results First Posted: 2024-06-27
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aminolevulinic Acid with daylight photodynamic therapy arm	Aminolevulinic Acid	This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted.

Primary Outcome Measures

Name	Time	Method
Percent Change in the Number of Actinic Keratoses	0 (baseline) and 6 months	Percent change in number of actinic keratoses at 6 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	2 days	Number of participants with adverse events such as crusting, erythema, edema, or pain

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States