Seborrheic Dermatitis

Here’s an article from Dermatology Times on a new rosacea treatment,
Finacea.

Topical azelaic acid 15 percent gel (Finacea) is more effective than
metronidazole gel 0.75 percent for improving erythema and reducing
inflammatory lesion counts in patients with mild to moderate
papulopustular facial rosacea, according to the results of a
multicenter, double-blind, randomized, parallel comparative trial.

The study enrolled 251 patients who were randomly allocated to twice-
daily treatment for 15 weeks with one of the two study medications.
By week 8, the two treatment groups had similar and statistically
significant reductions from baseline in erythema severity and numbers
of papules and pustules. However, as the study continued and patients
returned at weeks 12 and 15, it was noted that the effects of

metronidazole gel peaked and reached a plateau at week 8.

In contrast, patients using the new formulation of azelaic acid
benefited with progressive improvement throughout the study. At the
last visit, azelaic acid 15 percent gel was significantly more
effective than metronidazole 0.75 percent gel, while the two topical
medications were both well tolerated, reported lead investigator Boni
E. Elewski, M.D., professor of dermatology, University of Alabama,
Birmingham.

The active comparison trial enrolled men and women ages 18 to 83
years having between 10 and 50 facial pustules or papules and
persistent erythema. To be eligible for participation, patients could
have telangiectasia, but those with rhinophyma or ocular rosacea were
excluded.

Mean patient age was in the late 40s, and the average patient had
rosacea for eight years prior to enrollment. Patients were washed of
existing topical or systemic medications and used no other anti-
rosacea treatments during the study.

Mean baseline inflammatory lesion counts for patients in the
metronidazole and azelaic acid groups were 19 and 18, respectively.
Mean counts decreased to 7.7 in the metronidazole group at week 8 and
remained relatively unchanged thereafter with values of 7.9 at week
12 and 7.6 at week 15. In the azelaic acid group, mean lesion counts
decreased to 7.0 at week 8 and continued to fall, reaching 5.9 at
week 13, and 4.5 at week 15.

Approximately 47 percent of participants in both groups were judged
by the investigators to have achieved improvement in erythema
severity at week 8. The analysis of data from week 15, however,
showed a significant benefit favoring azelaic acid gel, which was
associated with erythema severity improvement in 61 percent of
patients versus 45 percent for metronidazole gel.

Telangiectases were not noticeably improved with either topical
treatment modality. That finding was not really surprising, Dr.
Elewski said, although she hypothesized that azelaic acid might offer
an advantage for preventing telangiectasia.

"If persistent and recurrent flushing is a trigger for the
development of telangiectasia, perhaps this formulation of azelaic
acid gel, working via its impressive effects on erythema, might limit
the appearance of new superficial vessels," Dr. Elewski said.

Negative Effects Minimal
Both study medications were well tolerated, and none of the patients
at Dr. Elewski’s center withdrew their participation because of
adverse events. Local stinging upon drug application was the most
commonly reported side effect for the azelaic acid group, but it was
generally transient, barely perceptible, and even less marked than
that which has been associated with use of azelaic acid 20 percent
cream. That latter difference may be explained by the fact that the
gel preparation is less acidic than the cream, Dr. Elewski observed.

The gel formulation is also distinguished from azelaic acid cream by
better bioavailability. In vitro studies performed using the Franz
cell model have shown azelaic acid in the gel formulation achieves
eightfold greater skin penetration compared with a cream formulation,
presumably because a higher percentage of drug is dissolved in the
gel.

"Clinicians should realize that azelaic acid 20 percent cream and
this new 15 percent gel preparation are distinctly different
products," Dr. Elewski said.

As some clinical trial participants sought to continue azelaic acid
treatment once the study was completed and because the drug they had
used was not yet on the market, Dr. Elewski began prescribing azelaic
acid 20 percent cream as an alternative. The experience of those
patients showed the cream was somewhat helpful, but overall the
patients were not as satisfied as they had been when being treated
with the new 15 percent gel, Dr. Elewski noted.

"I was loathe to tell these patients they would have to stop azelaic
acid after the trials ended, and I began to use the azelaic acid
cream 20 percent concomitantly with other available products, such as
topical metronidazole, with some good success. However, I believe
azelaic acid 15 percent gel can stand alone as excellent monotherapy
for rosacea, and it is a particularly good alternative for patients
who are frustrated with older medications," Dr. Elewski said.

Finacea is a product of Berlex. Dr. Elewski is a consultant for
Berlex.

This entry was posted on Saturday, June 12th, 2004 at 12:51 pm and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.