New Study Assesses Skin Hydration And Epidermal Function Of 2.5% And 5% Benzoyl Peroxide-Clindamycin Combinations
Las Vegas, NV – October 15, 2009 – Dermatologists agree that topical fixed-combination products containing clindamycin (clin) and benzoyl peroxide (BPO) are effective in the treatment of acne. However, products containing BPO concentrations at 5% or higher may limit use due to associated dryness and irritation.
A poster describing a new study of an optimized once-daily fixed combination of clindamycin phosphate 1.2% and BPO 2.5% (clin-BPO 2.5%) was presented at the Fall Clinical Dermatology Conference in Las Vegas and showed that the clin-BPO 2.5% formulation is non-irritating, maintains skin hydration and does not damage the skin barrier.
The objective of this study was to compare the effects of
clin-BPO 2.5% and clin-BPO 5% on epidermal functions and
irritation. This single-center, randomized, controlled
observer-blind study enrolled 22 subjects (4 male and 18 female,
ages 21-77, mean 45.6 years) with healthy volar forearm skin. Test
fields on the volar forearms were treated non-occlusively with 50
μl (50 mg) of once-daily clin-BPO 2.5% (Acanya® Gel) and
twice-daily clin-BPO 5% (BenzaClin® Topical Gel) according to
the dosage and administration sections of each product’s
respective package insert and applied by study site personnel. All
subjects received the same treatments during an 11-day treatment
period. An additional untreated test field served as a
control. Measurements assessing the skin barrier and skin
hydration were performed.
The study demonstrated that once-daily clin-BPO 2.5% was superior in maintaining skin hydration than twice daily clin-BPO 5%. A statistically significant decrease in skin hydration was seen with clin-BPO 5% reflecting a clear drying effect. Clin-BPO 2.5% revealed no relevant irritant effect or negative influence on skin hydration and no evidence of epidermal barrier impairment.
In clinical studies in over 2800 acne patients, the optimized
once-daily fixed combination of clindamycin phosphate 1.2% and BPO
2.5% (clin-BPO 2.5%) was shown to have minimal local cutaneous side
effects and was effective in reducing inflammatory and
non-inflammatory lesions in patients with moderate to severe
acne.
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About Acne Vulgaris
Acne vulgaris is a common skin disorder affecting 40 to 50 million
Americans, or approximately 85 percent of people at some point in
their lives. The disorder is thought to be caused by
overproduction of sebum, a normal oily substance on the skin
surface, combined with skin cells abnormally shed from the hair
follicle, and skin bacteria, Propionibacterium acnes, resulting in
inflammation in the skin in the form of acne. Combination
therapies targeting multiple pathogenic factors of acne are among
the most commonly prescribed acne treatments. In the past
year, more than five million patients with acne in the U.S. sought
treatment from a physician, resulting in over 17 million
prescriptions filled, according to data from SDI Health LLC and IMS
Health Inc.
About Acanya® Gel
Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%)
is indicated for the topical treatment of acne vulgaris in patients
12 years of age or older. In controlled clinical trials, the
following application-site adverse reactions occurred in less than
0.2% of patients treated with Acanya Gel: application-site pain
(0.1%), application-site exfoliation (0.1%), and application-site
irritation (0.1%). Patients are advised to avoid applying Acanya
Gel in mouth, eyes, or nose or on lips, and to minimize sun
exposure following application. Acanya Gel is the only
FDA-approved fixed combination antibiotic and benzoyl peroxide
(BPO) medication for once-daily treatment of both non-inflammatory
and inflammatory lesions of acne. Formulated in an aqueous-based,
alcohol-free gel, Acanya Gel was optimized to provide enhanced
bioavailability of BPO, creating an effective and well tolerated
product. In pivotal Phase III clinical trials, Acanya Gel
showed superior efficacy to the vehicle gel and both individual
active ingredients, while demonstrating excellent tolerability and
high patient satisfaction scores. Acanya Gel is marketed by
Coria Laboratories, a division of Valeant Pharmaceuticals North
America. More information about Acanya Gel and Important
Safety Information can be obtained at www.AcanyaGel.com.
About Coria Laboratories
Coria Laboratories is the dermatology division of Valeant
Pharmaceuticals North America, a subsidiary of Valeant
Pharmaceuticals International. With its acquisition of Coria
Laboratories Ltd. in October 2008, Valeant has created a fully
integrated portfolio of specialty pharmaceutical products focused
on medical dermatology. Coria Laboratories combines a commercial
organization with management expertise, a proven sales force and a
goal of developing and marketing innovative products, positioning
Coria Laboratories for dermatology industry leadership going
forward. Coria Laboratories is committed to establishing a
tradition of unparalleled service to the dermatology community,
with the critical goal of supporting dermatologists and their
practices through greater patient satisfaction with therapy.
For more information, please visit www.corialabs.com.
About Valeant
Valeant Pharmaceuticals International (NYSE: VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of neurology and dermatology. More
information about Valeant can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS:
This press release contains forward-looking statements, including,
but not limited to, statements regarding the efficacy, tolerability
and favorable safety profile of Acanya Gel and the potential for
increased patient compliance. These statements are based upon
the current expectations and beliefs of the management of Valeant
Pharmaceuticals International and are subject to certain risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. These risks
and uncertainties include, but are not limited to, the possibility
that some information regarding tolerability and efficacy may not
be apparent even in well designed clinical trials and other risks
and uncertainties discussed in Valeant’s annual report on
Form 10-K for the year ended December 31, 2008 and other filings
with the SEC. Valeant wishes to caution the reader that these
factors are among the factors that could cause actual results to
differ materially from the expectations described in the
forward-looking statements. Valeant also cautions the reader that
undue reliance should not be placed on any of the forward-looking
statements, which speak only as of the date of this release.
Valeant undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this release or to reflect actual outcomes.
Full prescribing information for Acanya Gel can be obtained at
www.AcanyaGel.com.
Contacts: Investors: Media: Laurie W. Little Suzanne Lane Valeant Pharmaceuticals Lane Communications 949.461.6002 212.757.6880 Laurie.Little@Valeant.com slane@thelcgroup.com
