CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Aminolevulinic Aciddrug
Likely dose
Topical aminolevulinic acid followed by activation by ambient sunlightAI-extracted
Key inclusion· 3
  • ✓Clinical diagnosis of more than 10 actinic keratoses on head and neck
  • ✓Age 18 years or older
  • ✓Ability to understand and willingness to sign written informed consent
Key exclusion· 5
  • ✕Currently undergoing anti-neoplastic therapy for actinic keratoses including topical imiquimod, 5-fluorouracil, ingenol mebutate, diclofenac, retinoids, or oral acitretin
  • ✕History of allergic reactions to compounds similar in chemical or biologic composition to aminolevulinic acid
  • ✕Known photosensitivity disorder including porphyria, lupus, polymorphous light eruption, or immunobullous disease
  • ✕Taking photosensitizing medications including griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, or tetracyclines

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03327831
NCT03327831Phase 4Completed
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UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

University of California, Irvine·interventional·Posted Oct 31, 2017·Updated Jun 27, 2024

In Brief

A Phase 4 clinical trial evaluating Aminolevulinic Acid for Actinic Keratosis. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 31, 2017
Enrollment StartApr 1, 2015
Primary CompletionFeb 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago

Interventions

Aminolevulinic Aciddrug

Topical application followed by activation by ambient sunlight