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Levulan Kerastick (Aminolevulinic Acid Hydrochloride) - Summary

 
 



SUMMARY

Levulan® Kerastick®
(aminolevulinic acid HCl) for Topical Solution, 20%
For Topical Use Only
Not for Opthalmic Use

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for Topical Solution, 20%, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone. Aminolevulinic acid HCl (ALA HCl) is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil.

The LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2, see table 2 for definition) of the face or scalp.


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NEWS HIGHLIGHTS

Media Articles Related to Levulan Kerastick (Aminolevulinic Acid)

Actinic Keratosis
Source: MedicineNet diclofenac Specialty [2013.12.20]
Title: Actinic Keratosis
Category: Diseases and Conditions
Created: 10/29/2001 12:05:00 PM
Last Editorial Review: 12/20/2013 12:00:00 AM

Keratosis Pilaris
Source: MedicineNet adapalene Specialty [2013.09.16]
Title: Keratosis Pilaris
Category: Diseases and Conditions
Created: 8/4/2008 12:00:00 AM
Last Editorial Review: 9/16/2013 12:00:00 AM

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Published Studies Related to Levulan Kerastick (Aminolevulinic Acid)

Intraoperative confocal microscopy in the visualization of 5-aminolevulinic acid fluorescence in low-grade gliomas. [2011.10]
OBJECT: Greater extent of resection (EOR) for patients with low-grade glioma (LGG) corresponds with improved clinical outcome, yet remains a central challenge to the neurosurgical oncologist. Although 5-aminolevulinic acid (5-ALA)-induced tumor fluorescence is a strategy that can improve EOR in gliomas, only glioblastomas routinely fluoresce following 5-ALA administration. Intraoperative confocal microscopy adapts conventional confocal technology to a handheld probe that provides real-time fluorescent imaging at up to 1000x magnification. The authors report a combined approach in which intraoperative confocal microscopy is used to visualize 5-ALA tumor fluorescence in LGGs during the course of microsurgical resection... CONCLUSIONS: Intraoperative confocal microscopy can visualize cellular 5-ALA-induced tumor fluorescence within LGGs and at the brain-tumor interface. To assess the clinical value of 5-ALA for high-grade gliomas in conjunction with neuronavigation, and for LGGs in combination with intraoperative confocal microscopy and neuronavigation, a Phase IIIa randomized placebo-controlled trial (BALANCE) is underway at the authors' institution.

A randomized, blinded, bilateral intraindividual, vehicle-controlled trial of the use of photodynamic therapy with 5-aminolevulinic Acid and blue light for the treatment of actinic keratoses of the upper extremities. [2011.09.01]
Background/Objective: Actinic keratoses (AKs) on the upper extremities are difficult to treat...

Effects of delta-aminolevulinic acid and vitamin C supplementation on iron status, production performance, blood characteristics and egg quality of laying hens. [2011.08]
An experiment was conducted to evaluate the effects of laying hen diets supplemented with delta-aminolevulinic acid (ALA) and vitamin C (VC) on productive performance, iron status and egg quality. A total of 252 Hy-line brown commercial laying hens were fed two levels of VC (0 and 500 mg/kg) and three levels of ALA (0, 5 and 10 mg/kg) in a 2 x 3 factorial arrangement from 57 to 63 weeks of age...

The effect of increasing fluence on the treatment of actinic keratosis and photodamage by photodynamic therapy with 5-aminolevulinic acid and intense pulsed light. [2011.06]
BACKGROUND AND OBJECTIVE: Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) and intense pulsed light (IPL) is a relatively new combination for the treatment of actinic keratosis (AK) and photodamage. The objective of this study was to determine the effect of increasing the fluence of IPL on the outcome of patients with these skin conditions... CONCLUSION: AK clearance, but not photorejuvenation, appears to improve with increasing fluence at the ALA PDT-IPL levels used in this study without serious adverse effects.

Detection and clinical outcome of urinary bladder cancer with 5-aminolevulinic acid-induced fluorescence cystoscopy : A multicenter randomized, double-blind, placebo-controlled trial. [2011.03.01]
BACKGROUND: The medical community lacks results from prospective controlled multicenter studies of the diagnostic efficacy of 5-aminolevulinic acid (5-ALA) cystoscopy on tumor recurrence in patients with superficial bladder tumors... CONCLUSIONS: In comparison to the placebo, 5-ALA cystoscopy did not increase the rates of recurrence-free or progression-free survival 12 months after tumor resection. Although more tumors per patient were detected in the 5-ALA group, the higher detection rate did not translate into differences in long-term outcome. Copyright (c) 2010 American Cancer Society.

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Clinical Trials Related to Levulan Kerastick (Aminolevulinic Acid)

Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK) [Recruiting]

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme [Recruiting]
The purpose of this study is to investigate the safety and performance of an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery. It is also being studied to determine if there are differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance imaging (MRI)

Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK) [Not yet recruiting]
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Fluorescence-guided Surgery for Low- and High-grade Gliomas [Recruiting]
Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat. Mounting evidence suggests that survival improves with greater tumor removal, yet being able do a complete removal can be difficult due to the tumor's infiltrating nature. 5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3 hours before surgery, is selectively taken up by glioma cells and causes a red/pink fluorescence (glow) under a blue light that allows tumor margins to be seen during the course of surgery. While this compound is used as a standard-of-care agent in Europe, it remains under testing by the Food and Drug Administration (FDA). A recent clinical trial in Germany, however, has demonstrated a significant improvement in the rate of complete resection for certain brain tumors (65% vs. 34%).

The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the special microscope during surgery will greatly lower the amount of tumor left behind.

Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery with 5-ALA given together with Gliadel wafer, followed by radiation therapy and temozolomide, in treating patients with primary glioblastoma.

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Page last updated: 2013-12-20

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