CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
aminolevulinic aciddrug
Likely dose
20% topical aminolevulinic acid with 4-5 hour or 18-24 hour applicationAI-extracted
Key inclusion· 4
  • ✓Diagnosed with actinic keratoses
  • ✓Histologically proven superficial or nodular basal cell carcinoma (BCC)
  • ✓Histologically proven squamous cell carcinoma in situ (Bowen's disease)
  • ✓Histologically proven microinvasive squamous cell carcinoma
Key exclusion· 5
  • ✕Nodular BCC greater than 4 mm thick that will not be surgically removed
  • ✕Carcinoma with uncertain margins requiring Moh's surgery
  • ✕Known photosensitivity disease
  • ✕Porphyria or hypersensitivity to porphyrins

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

Search/NCT00002975
NCT00002975Phase 2Completed
CompareCT.gov

A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses

Roswell Park Cancer Institute·interventional·Posted Jan 27, 2003·Updated Oct 10, 2013

In Brief

A Phase 2 clinical trial evaluating aminolevulinic acid for Non-melanomatous Skin Cancer and Precancerous Condition. Completed, enrolled 180 participants across 1 site.

Detailed Summary

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-melanomatous Skin Cancer, Precancerous Condition
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartFeb 1, 1997
Primary CompletionApr 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 12.2 yearsPosted 23.4 years ago

Interventions

aminolevulinic aciddrug