Levulan
Encyclopedia
Levulan photodynamic therapy
is a treatment method for certain skin
conditions developed by DUSA Pharmaceuticals
. The active ingredient is δ-aminolevulinic acid
(ALA).
(FDA) approval for actinic keratosis
was received in December 1999.
for 15 minutes. This generates reactive oxygen species in the skin that can lead to cell death. The treated areas are sensitive to light, and patients must protect themselves against bright sunshine
for up to 40 hours after treatment. Patients must stop using topical acne medicine and avoid steam rooms, hot showers, and generally protect the skin in every way possible for up to one week after treatment.
but this is an off-label use
, which means it is not approved by the FDA.
On October 2008 Dusa Pharmaceuticals announced that it was no longer developing Levulan for the treatment of acne after the phase II results failed to show statistically significant results.
In May 2007 the U.S. FDA granted Orphan Drug Designation for Levulan PDT for the treatment of esophageal dysplasia, a complication of Barrett's esophagus
.
Photodynamic therapy
Photodynamic therapy is used clinically to treat a wide range of medical conditions, including malignant cancers, and is recognised as a treatment strategy which is both minimally invasive and minimally toxic...
is a treatment method for certain skin
Skin
-Dermis:The dermis is the layer of skin beneath the epidermis that consists of connective tissue and cushions the body from stress and strain. The dermis is tightly connected to the epidermis by a basement membrane. It also harbors many Mechanoreceptors that provide the sense of touch and heat...
conditions developed by DUSA Pharmaceuticals
DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is pharmaceutical company based in Wilmington, Massachusetts that specializes in dermatology products. The major focus of the company includes medications used in the treatment of actinic keratoses and acne....
. The active ingredient is δ-aminolevulinic acid
D-Aminolevulinic acid
δ-Aminolevulinic acid is the first compound in the porphyrin synthesis pathway, the pathway that leads to heme in mammals and chlorophyll in plants....
(ALA).
Actinic keratosis
U.S. Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) approval for actinic keratosis
Actinic keratosis
Actinic keratosis is a premalignant condition of thick, scaly, or crusty patches of skin. It is more common in fair-skinned people. It is associated with those who are frequently exposed to the sun, as it is usually accompanied by solar damage...
was received in December 1999.
Treatment protocol
A 20% solution of ALA is applied to the lesions, and after a 6 hour wait to allow proper penetration of the skin, the treatment area is irradiated with blue lightLight
Light or visible light is electromagnetic radiation that is visible to the human eye, and is responsible for the sense of sight. Visible light has wavelength in a range from about 380 nanometres to about 740 nm, with a frequency range of about 405 THz to 790 THz...
for 15 minutes. This generates reactive oxygen species in the skin that can lead to cell death. The treated areas are sensitive to light, and patients must protect themselves against bright sunshine
Sunlight
Sunlight, in the broad sense, is the total frequency spectrum of electromagnetic radiation given off by the Sun. On Earth, sunlight is filtered through the Earth's atmosphere, and solar radiation is obvious as daylight when the Sun is above the horizon.When the direct solar radiation is not blocked...
for up to 40 hours after treatment. Patients must stop using topical acne medicine and avoid steam rooms, hot showers, and generally protect the skin in every way possible for up to one week after treatment.
Acne
Levulan is also prescribed for the treatment of acneAcne vulgaris
Acne vulgaris is a common human skin disease, characterized by areas of skin with seborrhea , comedones , papules , pustules , Nodules and possibly scarring...
but this is an off-label use
Off-label use
Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration...
, which means it is not approved by the FDA.
On October 2008 Dusa Pharmaceuticals announced that it was no longer developing Levulan for the treatment of acne after the phase II results failed to show statistically significant results.
Barrett's esophagus
A phase II trial was initiated in 2004.In May 2007 the U.S. FDA granted Orphan Drug Designation for Levulan PDT for the treatment of esophageal dysplasia, a complication of Barrett's esophagus
Barrett's esophagus
Barrett's esophagus refers to an abnormal change in the cells of the inferior portion of the esophagus. A positive diagnosis generally requires observing specific macroscopic and microscopic changes...
.