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Completed

NCT Number: NCT03327831

Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Irvine

Irvine, California, 92697-2400, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminolevulinic Acid

Drug

Topical application followed by activation by ambient sunlight

Other names: Kerastick

Primary outcomes

  1. Percent Change in the Number of Actinic Keratoses

    Time frame: 0 (baseline) and 6 months

    Percent change in number of actinic keratoses at 6 months

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 2 days

    Number of participants with adverse events such as crusting, erythema, edema, or pain

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2017
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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