Azelex
New Prescription Acne Treatment Now Available in U.S.
IRVINE, Calif., April 9, 1996
AZELEX(R) (azelaic acid cream) 20% topical cream,
the first new prescription drug indicated for mild-to-moderate inflammatory
acne vulgaris in 10 years, was introduced today by Allergan Herbert, one of the
skin care companies of Allergan, Inc.
"Noncompliance has been a major problem with acne treatment because prior
medications have not been designed with a woman's lifestyle and cosmetic
routine in mind," said Lenore S. Kakita, MD, assistant clinical professor
of dermatology, UCLA School of Medicine. "AZELEXcan be used under makeup,
moisturizers, sunscreens, and other topical medications because it has been
designed specifically with women in mind."
AZELEX is a completely new class of acne therapy, chemically different from all
currently available acne medications, including retinoids and alpha-hydroxy
acids. It is an azelaic acid cream made of a naturally occurring substance
found in wheat.
AZELEX is believed to work uniquely with dual modes of action -- antimicrobial
activity and normalization of keratinization (the process by which epithelial
cells mature as they move toward the skin surface and then slough off) -- which
attacks two of the major causes of acne.
The majority of patients start to see improvement in their acne within 4 weeks.
Excellent Efficacy and Safety
"In developing this new generation of acne therapy, the challenge was to
combine a high rate of efficacy with a low rate of side effects in a
formulation cosmetically acceptable to adult women," said Nicholas J.
Lowe, MD, FRCP, FACP, clinical professor of dermatology, UCLA School of
Medicine. "AZELEX" meets these criteria, providing women with a
significant new weapon to fight mild-to-moderate inflammatory acne and thus
enhance skin care."
A proven track record of efficacy and safety has been demonstrated in more than
6 years of European clinical experience and in two large- scale U.S. clinical
trials.
In two multicenter, double-blind studies of 545 people with inflammatory acne,
AZELEX was significantly more effective than the vehicle in reducing the number
of inflammatory acne lesions.
Cosmetic Benefits
Clinical trial participants were asked to provide their overall impression of
the cosmetic characteristics of the cream and to rate it in terms of texture,
ease of application, appearance, and odor. More than 80% reported a favorable
or neutral impression of the cosmetic characteristics of the study cream. The
cream is mild, moisturizing, and noncomedogenic (meaning it does not promote
the formation of whiteheads or blackheads).
Minimal Side Effects
Treatment with AZELEX is associated with a low incidence of generally mild and
transient side effects. The most common adverse reactions, occurring in 1% to
5% of clinical trial participants, were pruritus (itching), burning, stinging,
and tingling; there is also potential for allergic reactions. Additionally,
patients with dark complexions should be monitored for early signs of
hypopigmentation.
AZELEX produces no known interactions with other topical acne medications.
Unlike topical and oral antibiotic treatments for acne, there has been no
reported bacterial resistance to AZELEX.
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