Supplement to Aesthetic Buyers Guide® • July/August 2004 Levulan Photodynamic Therapy Offers
Effective Acne Treatment Alternative

The rapidly increasing interest in Levulan Dr.Anderson’s original exposure to the novel com- pound was as an investigator for skin cancer. “When Pharmaceuticals, Inc. (Wilmington, Mass.) to ALA enters the skin, it becomes metabolized. The skin treat acne and other medical conditions can largely be cells turn it into a photosensitizer called porphyrin.
traced back to the efforts of Rox Anderson, M.D., Earlier, we had conducted a study showing that seba- research director of photomedicine at the Wellman ceous glands were the most active part of the skin for Center, Massachusetts General Hospital, Boston. “I producing porphyrins. Sebaceous glands are the root think light-activated drugs are extremely powerful,” Dr.
Anderson said. “The use of topical 5-aminolevulinic acid “Although there are many different treatments for
(ALA) is one of the early examples of what I expect to acne, we have no cures,” observed Dr. Anderson. “We real- become a growing number of diverse drugs in the near ly need a cure, something that has a very long-term effect future. I believe we are near the beginning of this cycle and treats the activity of the sebaceous gland. Drugs It was four years ago, at
“This is great
news because it
has a long lasting
effect. There was
a strong effectiveness
against even severe acne.”
- Rox Anderson, M.D.
different doses. In the study, we were able to demon- Yoshiyasu Itoh, M.D., Ph.D. “Those results were similar strate that treatment inactivates the bacteria in the to ours,” Dr. Anderson conveyed. “However, back in hair follicles that is part of the reason people develop 2000, ALA was not approved for anything. It was an acne. But much more exciting is that we were able to experimental drug. Since then, the drug is on its way to show that at high doses, treatment actually shuts down being embraced by the aesthetic community. ALA is now the sebaceous gland in the skin. This is great news FDA approved for the treatment of actinic keratoses.
because it has a long lasting effect. There was a strong Because the drug is approved, physicians can actually effectiveness against even severe acne.” order it and many have begun off-label use to treat Medical Insight, Inc.® • 27796 Soller Mission Viejo, CA 92692 • (949) 830-5409 • Facsimile: (949) 830-8944 •
acne. I’m also optimistic about the recent work of look- There is a kind of clinical creativity going on. ALA PDT ing at different light sources to activate ALA. The poten- actually treats a number of aspects of chronic sunlight tial to use flashlamps, which are very fast treatment injury to the skin. But I don’t ever expect ALA to be able sources, with ALA to treat acne is certainly exciting.” to remove blood vessels. PDT therapy really is meant to As a physician, Dr. Anderson considers himself be used synergistically with lasers and other modalities somewhere in the middle when it comes to implement- ing a wide range of applications for new technologies. “I Overall, Dr. Anderson believes that the use of
Levulan PDT will continue to grow. “I think it will be
“Because Levulan PDT has shown that it
useful for acne and other follicular disorders of the skin.
My guess is that it will be used in two different modes.
can be very effective in treating acne,
One is a low dose maintenance mode. I can even imag- physicians are now starting to incorporate
ine combining ALA with sunscreens and letting the sundo the work for you. This would be a totally different this therapy creatively into their practices.”
approach. The other mode would be a high dose, office- like to undertake experiments and come up with new based procedure. I predict this approach will someday approaches to things. But it takes awhile before we real- be used for severe acne. I also believe ALA has the ly understand where it fits into the whole picture.
potential to be as effective as oral retinoids. So ALA will Because Levulan PDT has shown that it can be very likely become a very popular approach. But I don’t think effective in treating acne, physicians are now starting to we will see ALA replacing our use of creams, topical incorporate this therapy creatively into their practices.
retinoids, antibiotics and benzoyl peroxide.” Clinical Roundtable: Levulan PDT Acne Tx
Editors Note: For this news article, we inter-
“We needed an aggressive treatment
viewed a select group of leading researchers to for acne patients who
elicit their views and clinical experience regard- did not feel comfort-
ing the use of Levulan PDT to treat acne.
able taking antibiotics
or Accutane.”
Why did you add Levulan to your
- Dore Gilbert, M.D.
practice for the treatment of acne?
Macrene Alexiades-Armenakas, M.D. – Following
Gerald Bock, M.D. – We had the BLU-U lamp (from
the discovery that ALA in combination with the long DUSA) available and wanted alternative options for our pulsed pulsed dye laser (LP PDL) was safe and effective in the treatment of actinic keratoses (Alexiades-Armenakas and Geronemus, Arch Derm, October 2003), Dore Gilbert, M.D. – We needed an aggressive treat-
we noted improvement in sebaceous hyperplasia and ment for acne patients who did not feel comfortable tak- acne rosacea as well. We followed this up with the first ing antibiotics or Accutane. Many patients don’t want to study on the treatment of acne using ALA with the LP take Accutane due to the numerous systemic side effects PDL vs. ALA PDL, which was published in abstract form – dryness, scaling, achy joints, the birth control pill and which I presented at ASLMS in 2003 (Alexiades- issue for women, and so on. If patients are given an Armenakas, et al, American Society for Laser Medicine option, they will usually choose a less complicated route.
and Surgery Abstracts, Anaheim, April 2003). It has In addition, a recent report in the Journal of the reproducibly shown to be effective in the treatment of American Medical Association (JAMA) implicates pro- both comedonal and inflammatory and cystic acne.
longed use of antibiotics with invasive breast cancer.
Until that study is proven to be a faulty study, I have anobligation to my patients, particularly my female “Studies seem to suggest that PDT
patients, to make them aware and allow them to choosewhich course of treatment they are most comfortable may hold the key. In my
with. Frankly, anytime there is an alternative to an experience, I’ve had
existing treatment that is riddled with as many side some wonderful results
effects as the current traditional acne regimens, I feelobligated to investigate it. As it turns out, Levulan and treating cystic acne
PDT are proving to be exceptional alternatives for treat- with Levulan PDT along
with either the pulsed dye laser or
Flor Mayoral, M.D. – There have been several reports
the BLU-U lamp.” - Mark Nestor, M.D., Ph.D.
that show ALA PDT to be effective. Even thoughAccutane has been the gold standard for the treatmentof severe acne, its cost, potential teratogenicity and theside effect of depression in rare patients have made gland. Also, when I heard that it was increasing the pro- some parents unwilling to allow their teenagers to take toporphyrin destruction of the bacteria, I realized that this medication Levulan provides me a viable treatment it had a dual effect. We initially began Levulan as a sec- ondary treatment in our practice. This was for peoplewho had already had two or three treatments of Mark Nestor, M.D., Ph.D. – Some standard treat-
Accutane and were frustrated. They did not want to deal ments for acne have significant limitations. For cystic with the side effects of the drug. We felt that the acne, in particular, the two treatments that are some- Levulan worked in a similar fashion to Accutane. We what effective are long-term oral antibiotics and also have a number of people in our practice who are Accutane. However, as mentioned, a recently published holistically committed and refuse any type of oral med- study indicates that long-term oral antibiotics may be ication, including antibiotics or Accutane. Yet, they have associated with breast cancer in women. Similarly, severe cystic scarring acne, and need advanced treat- Accutane is becoming harder and harder to prescribe.
ment beyond the traditional topical treatments.
So we have limited ability to treat cystic acne patients.
We also find that Levulan is a wonderful treatment Studies seem to suggest that PDT may hold the key. In for adult acne. Many of these patients have tried every my experience, I’ve had some wonderful results treating topical and oral medication, but remain frustrated. We cystic acne with Levulan PDT along with either the are now beginning to use Levulan as a frontline treat- ment for acne when anticipating prolonged treatmentwith either systemic antibiotics and/or Accutane. The Donald F. Richey, M.D. – I became very interested in
Levulan when I realized that its primary function wasto reduce the size and activity of the sebaceous oil How does Levulan fit into your acne
treatment regimens?

“We are now beginning to use
Dr. Alexiades-Armenakas – For patients who have
Levulan as a frontline
failed systemic antibiotics, topical treatments, and are treatment for acne
not candidates or are unwilling to take Accutane, laseroptions are recommended, including PDT.
when anticipating pro-
longed treatment with
Dr. Bock – We are still evaluating ALA PDT, but it
appears that the BLU-U lamp with Levulan is much
either systemic antibi-
more effective than the blue light alone.
otics and/or Accutane.”
- Donald F. Richey, M.D.
Dr. Gilbert – Levulan PDT has become the primary
treatment modality of choice for pustular or cystic acne.
If patients have mild acne, then I am inclined to use theBLU-U lamp by itself.
Dr. Mayoral – Levulan is a great alternative for those
who have failed Accutane and also for those patients
who fail treatments because of non-compliance. It is simple, effective and has minimal side effects.
Dr. Nestor – We use Levulan to treat moderate-to-
severe nodular papular and papular cystic acne, typi-
cally three sessions. We can use Levulan in combination
with BLU-U light alone or in combination with topicals.
Dr. Richey – Levulan is increasingly becoming the pri-
mary a line of defense in our practice for treating acne.
dermabrasion, then the Levulan Kerastick is applied.
What light sources and treatment pro-
We allow the Levulan to incubate for approximately 45 tocol do you typically use?
minutes. The patients that are receiving the BLU-U willbe exposed to this light source for 12 minutes. For Dr. Alexiades-Armenakas – The
patients receiving treatment with the Vbeam, we use the following settings: two passes with 50% overlap, a 10 mm spot size, and a 6 ms pulse duration at 7 J/cm2.
inflammatory acne and the BLU-Ulamp for comedonal, each following Dr. Nestor – The most common treatment protocol is
about three sessions, roughly three weeks apart, usingLevulan anywhere from 30 minute to 60 minutes after Macrene Alexiades-
Dr. Bock – We do an acetone
microdermabrasion. This is followed by pulsed dye laser Armenakas, M.D.
at low fluence and nonpurpuric doses. We especially use on for at least one hour. The BLU-U light exposure is the BLU-U lamp in darker skinned individuals because between 8 and 20 minutes. Most of the time we use 15 the pulsed dye laser may have more of a problem get- minutes of BLU-U light with Levulan.
ting through to the pigment. We can also substitute anIPL device, again at fairly low fluence, 24 to 26 J/cm2.
Dr. Gilbert – The light sources that we typically use for
Levulan PDT are the BLU-U and intense pulsed light
“The most common treatment protocol
(IPL). The blue light treatment begins with a very mild is about three sessions, roughly three
scrub with acetone. We then evenly apply the Levulan tothe affected areas of the face, neck or back. We allow weeks apart, using Levulan anywhere
approximately 30 minutes for incubation, and then from 30 minute to 60 minutes after
expose the patient to the BLU-U for eight minutes.
The IPL protocol is the same, except of course for microdermabrasion.”
the light source. We use 3.0, 6.0 IPL treatment with anenergy setting of 30 J/cm2. After we perform one pass Dr. Richey – For acne, we also use the BLU-U with
with the IPL, the patient sits for two to four minutes in Levulan. We start with a 30 minute incubation after the BLU-U in order to expose the area or areas to an an acetone scrub. We typically give the patient 12 min- additional wavelength of light. This also ensures cover- utes of actual light exposure. We plan on four sessions age of any areas that may have been missed by the IPL at one week intervals. We sometimes increase the drug incubation period, depending on the erythema thatdevelops after the treatments. We also sometimes use Dr. Mayoral – I use the BLU-U or the Vbeam laser for
IPL, but that is only for our patients undergoing pho- my acne patients. The patients will first have a micro- How do your patients respond? Please
have followed some patients close to two years who have summarize your clinical results and
remained clear. With three treatments, results are sim- observations.
ilar with Accutane. About 20% to 30% of patientsrequire more than three sessions.
Dr. Alexiades-Armenakas – Typically, they are all
cleared in two to four treatments, spaced three weeks
Dr. Richey – Our acne patients have responded very
satisfactorily. We have had a few minimal responders,and we have had some almost miraculous responders.
Dr. Bock – We have only treated a limited number of
Some of our patients are absolutely thrilled that they patients. But we have seen a spectacular result in one have been able to clear their cystic scarring acne adult male who was on continuous Accutane, antibiotics without having to take any type of systemic medica- and anti-inflammatory agents for two and a half years, tion or spend months and months using topical without clearing. He cleared dramatically after a single BLU-U lamp and Levulan treatment. He also remainedclear for a month, when he had a second treatment, andstill remains clear several weeks later.
“Levulan PDT could
Dr. Gilbert – Most of our patients have an immediate,
become a first line
minimal, erythematous reaction. Within two to twelve modality in the
hours, most patients will develop more erythema.
However, the amount of erythema is not predictable.
treatment of acne.”
Some patients may have only a mild degree of erythe- - Gerald Bock, M.D.
ma, while others will have erythema followed by scalingfor another three to four days.
Our clinical results have been very encouraging with about an 80% success rate. After two to four treat- What role will Levulan PDT fill in the
ments, most patients are acne free, or have a significant treatment of acne versus systemic phar-
improvement in their acne condition for six months to maceuticals and topicals?
one year. However, some patients require maintenancetreatments after about six months. Maintenance treat- Dr. Bock – If our initial experience is borne out,
ments follow the same protocol as the initial treat- Levulan PDT could become a first line modality in the ments, but they are only done on an ‘as needed’ basis.
treatment of acne. Its low side effect profile combinedwith significant effectiveness could be very attractive.
Dr. Mayoral – My patients toler-
ate the BLU-U lamp and Levulan
Dr. Gilbert – In the future Levulan PDT will become
one of the mainstay treatments for pustular and cystic acne. I’m very excited about adding Levulan PDT to my practice. It is proving to be a great option for my patients who don’t wish to, or cannot, take Accutane or In addition, the process of Levulan PDT has numer- Flor Mayoral, M.D.
ous ancillary cosmetic benefits. For older patients, Levulan PDT therapy also treats actinic keratoses. The The Vbeam also renders a great response, although procedure can also diminish, if not eliminate, brown some patients complain of pain. I have seen a couple of spots and even overall pigmentation. It can tighten patients that became a little edematous for a couple of pores, prevent further acne scaring, and smooth existing days when I combine this laser with the ALA. This resolves quickly without any problem.
Dr. Mayoral – The use of Levulan PDT for the treat-
Dr. Nestor – Overall, about 60% of our patients realize
ment of acne has the potential for being very effective greater than 80% long-term reduction in their acne. We with less incidence of side effects than oral medications.
It could also be more economical for insurance compa-nies and patients.
Dr. Nestor – Topicals can be used with Levulan PDT
without a problem. The idea is to stay away from sys- temic medications when necessary. Levulan can alsobe used as augmentation for patients who are on sys-temic agents, but no responding well. Levulan PDTcan fit in anywhere because there are no systemic Almost everything we do as physicians is really combination therapy. Whether it is PDT or merelyBLU-U light, I have found that combination therapy with Accutane are multiple, and with further restric- works the best. For instance, the vitamin A related top- tions from the FDA, this is going to be a difficult treat- ical drug adapalene (Differin) is truly great for come- ment program to orchestrate. We also feel that for the donal acne, and can help enhance all treatments. In patient who takes oral antibiotics, the inherent prob- fact, we’re preparing to start a half-face study compar- lems of photosensitivity, yeast infections and the con- ing Differin and BLU-U together versus the BLU-U troversy over breast cancer must all be carefully lamp alone for mild to moderate acne.
weighed. I am thrilled that we can now offer an alter-native topical treatment for treating mild through Dr. Richey – I feel Levulan will be a very important
severe acne. Our patients have more choices, and we can part of acne treatment, and will be a very competitive customize our Levulan PDT treatments to their partic- product to systemic pharmaceuticals. The problems R O U N D T A B L E P A R T I C I P A N T S :
Macrene Alexiades-Armenakas, M.D., Ph.D.
Flor Mayoral, M.D.
A dermatologist in private practice in New York City
A dermatologist in private practice in Miami, Fla.
and a clinical instructor of dermatology at the
voice (305) 665-6166
Yale University School of Medicine.
fax (305) 662-4649
voice (212) 570-2067
fax (212) 861-7964

Mark Nestor, M.D., Ph.D.
A clinical associate professor of dermatology and

Gerald Bock, M.D.
dermatologic surgery at the University of Miami
A dermatologist in private practice in Stockton, Calif.
School of Medicine in Florida.
voice (209) 957-0720
voice (305) 933-6716
fax (209) 957-0801
fax (305) 933-3853
Dore Gilbert, M.D.
Donald F. Richey, M.D.
An associate clinical professor of dermatology at the
A cosmetic dermatologist in private practice in
University of California, Irvine. For the past 12 years,
Chico, Calif.
he has also served as chief of dermatology at
voice (530) 342-3686
HOAG Memorial Hospital in Newport Beach, Calif.
fax (530) 342-4199
voice (949) 718 1222
fax (949) 718 1220


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