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Levulan Kerastick (Aminolevulinic Acid Hydrochloride) - Summary

 
 



SUMMARY

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for Topical Solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone. 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 (PDT) Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.


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NEWS HIGHLIGHTS

Media Articles Related to Levulan Kerastick (Aminolevulinic Acid)

Keratosis Pilaris
Source: MedicineNet adapalene Specialty [2015.02.23]
Title: Keratosis Pilaris
Category: Diseases and Conditions
Created: 8/4/2008 12:00:00 AM
Last Editorial Review: 2/23/2015 12:00:00 AM

Picture of Actinic Keratosis (Solar Keratosis)
Source: MedicineNet Actinic Keratosis Specialty [2014.12.08]
Title: Picture of Actinic Keratosis (Solar Keratosis)
Category: Images
Created: 11/12/2009 9:03:00 AM
Last Editorial Review: 12/8/2014 12:00:00 AM

Understanding Actinic Keratosis
Source: MedicineNet Actinic Keratosis Specialty [2014.12.01]
Title: Understanding Actinic Keratosis
Category: Doctor's Views
Created: 9/18/2008 12:00:00 AM
Last Editorial Review: 12/1/2014 12:00:00 AM

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Published Studies Related to Levulan Kerastick (Aminolevulinic Acid)

5-aminolevulinic acid, a precursor of heme, reduces both fasting and postprandial glucose levels in mildly hyperglycemic subjects. [2013]
hyperglycemic adults... CONCLUSION: An oral intake of ALA would be a novel approach to prevent type 2

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.

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Clinical Trials Related to Levulan Kerastick (Aminolevulinic Acid)

The Use of 5-aminolevulinic Acid (ALA) as an Intraoperative Tumor Marker for Resection of Pediatric Central Nervous System (CNS) Tumors [Not yet recruiting]
Surgery is the cornerstone treatment of most pediatric CNS tumors, including astrocytomas, ependymomas, medulloblastomas, and many other pathologies. In most pediatric CNS tumors, the aim of surgery is maximal tumor resection, while preserving neurological function. Extent of tumor residual has been shown to be a major prognostic factor for progression free survival (PFS), and survival in several malignant and low-grade tumors such as medulloblastomas, ependymomas, and astrocytic tumors. 5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of various cancers. Following oral admission, during surgery, the tumor tissue is illuminated by blue light. Tumor cells tend to metabolize 5-ALA to a porphyrin named protoporhyrin IX (PpIX). PpIX reacts with the blue light and emits a pinky color (- fluorescence). This enables the surgeon to better identify tumor cells and perform a more extensive resection. Over recent years, many studies have proven the efficacy using 5-ALA for resecting various intracranial and spinal tumors, thus achieving a better tumor control. In the suggested study, we propose using the same technique for various pediatric central nervous system tumors. We will focus on the correlation between various pathologies and the fluorescence, trying to deduce the role of 5-ALA in resection of specific pathologies. Also, we will study the safety of 5-ALA use in the pediatric population.

Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis [Not yet recruiting]
To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.

Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood [Completed]
PURPOSE: The purpose of this investigation is to determine if a relationship exists between the administration of a dietary supplement containing 5-ALA and sleep and mood. HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one study involving test mice, researchers found that the regular administration of 5-ALA appeared to raise serotonin levels in the brain. One hypothesis is by increasing serotonin levels, 5-ALA may contribute to improvements with sleep, along with additional improvements in mood, calmness, irritability and coping abilities. 5-ALA may also support hormonal regulation, including melatonin, in the pineal gland and corticosteroid regulation in the adrenal glands. Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism of cells, such that its own circadian rhythms are better defined. 5-ALA may support neuronal function and assistance with "mental energy" needed to deal with stress in daily life, producing better feelings of "coping", "less irritability" and lowering an individual's feelings of "fatigue", all of which may contribute to a reduction of "pessimism" regarding the ability to deal with daily tasks. DESIGN: This will be a double-blinded, randomized parallel-group comparison study. SAMPLE: 40 participants will be randomized to the following 2 study groups for each outcome

variable (Sleep and Mood): Control Group - 20 participants and Intervention Group - 20

participants. A table of random numbers will be used to assign the participants.

A Study of the Specificity and Sensitivity of 5-ALA Fluorescence in Malignant Brain Tumors [Withdrawn]
Extent of resection is a very important prognostic factor affecting survival in individuals diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma tumor cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts at total resection. The investigators propose to identify the borders of malignant gliomas intraoperatively using oral 5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and thereby provide an opportunity for more complete tumor resection. When exogenous 5-ALA is provided at increased concentration the tumor cells will become fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively and facilitates complete resection. The following data will be collected:

- Dose-limiting toxicity data

- Tumor fluorescence assessed by neurosurgeon (0 to +++) in three distinct areas of

fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence)

- Tumor density from biopsies obtained by the neurosurgeon in the same three distinct

areas of fluorescence and assessed by neuropathology (Solid tumor, Tumor mixed infiltrating normal brain, No tumor)

- Neurosurgeon's intra-operative estimate of residual tumor

- Neuroradiologist's estimate of post-operative residual tumor on MRI

- Time to progression by MRI

- Survival (time to progression, one year survival rate and total survival

This trial will evaluate:

- The toxicity of a single dose of oral 5-ALA given pre-operatively.

- The sensitivity and specificity of 5-ALA - Protoporphyrin IX (Pp IX) as an

intraoperative fluorescent detection agent and aid for resection of tumor tissue remaining in the walls of the resection cavity of primary and recurrent malignant brain tumors.

- The relationship of the neurosurgeon's estimate of the extent of malignant glioma

resection (as guided by tumor fluorescence) to the actual extent of resection determined by post-operative imaging.

- The time-to-progression, one year survival rate and total survival as a function of the

extent of resection. Following completion of the phase 1 portion of this trial, an additional 15 subjects will be entered at the recommended phase 2 dose level in order to further define the above parameters at the recommended phase 2 dose level.

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

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Page last updated: 2015-02-23

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