Study Shows ALUSTRA More Than Twice as Effective as Tretinoin in Treating Melasma
SCOTTSDALE, Ariz.--April 8, 2002--Medicis Pharmaceutical Corporation (NYSE:MRX) today announced a recently completed study shows that its ALUSTRA(TM) (hydroquinone USP 4%) cream is twice as effective in treating melasma as topical tretinoin (Renova(R) 0.05%).
Hydroquinone and tretinoin are the most popularly prescribed medications for melasma, the darkening of skin pigmentation around the cheeks and forehead, often referred to as "the mask of pregnancy." Melasma can also be caused by other changes in female hormones, including the use of birth control pills.
"The study clearly demonstrates that retinol plus hydroquinone is more effective than tretinoin in improving melasma severity or improving the appearance of the mask," said Zoe Draelos, M.D., investigator and clinical associate professor of dermatology in the Department of Dermatology at Wake Forest University School of Medicine in Winston-Salem, N.C.
The 16-week randomized and investigator-blinded study showed the patient group using ALUSTRA had a 74.8% reduction (from 16.6 to 4.3) in the their melasma area and severity index (MASI) scores compared to a 32.0% reduction (15.8 to 10.5) in patients using tretinoin. Full findings of the study are pending publication in a dermatology journal. Pending publication study data and patient before and after photos are available upon request from Medicis.
"The tretinoin did not induce pigment lightening as rapidly or to as great a degree in patients with melasma as the combination retinol and hydroquinone product," Draelos said. "This study found a benefit to combining retinol and hydroquinone in speeding both improvement of melasma but also in improving those cosmetic signs associated with overall facial photoaging."
The study also found that ALUSTRA is less irritating on the skin than tretinoin. Patients using ALUSTRA saw a 59.6% improvement in the tactile roughness, while those on tretinoin saw their skin roughness worsen by 4.3% at 16 weeks.
The patient tolerability of ALUSTRA makes it a long-term treatment for melasma, researchers added.
"This study clearly shows that ALUSTRA is a first line of defense against melasma because it provides excellent results for the majority of patients and does not expose the patient to a potentially harmful ingredient, such as a steroid," said Mitchell Wortzman, Ph.D., executive vice president, research and development at Medicis. "With its combination of retinol and hydroquinone, this study proves ALUSTRA is superior to tretinoin in treating cosmetic defects, fine lines and wrinkles and melasma."
Occasional cutaneous hypersensitivity may occur with hydroquinone therapy. Consumers should test for skin sensitivity before using ALUSTRA. Hydroquinone may cause unwanted effects if not used as directed. ALUSTRA does not contain sunscreen.
Study Background
The study was designed to evaluate the efficacy and tolerance of a topical product containing hydroquinone and retinol (ALUSTRA) versus topical tretinoin 0.05% emollient cream for the treatment of hyperpigmentation and photodamage. To support the investigator-blind nature of the study, a clinical research coordinator distributed all test products.
A total of 44 study subjects, all women under 50 years old, were randomized into two treatment groups of 22 women each. Group A subjects used ALUSTRA and Group B subjects used the tretinoin cream. Subjects in treatment Group A were instructed to apply their assigned test product once daily in the evening for the first two weeks of the study and twice daily in following weeks. Subjects in treatment Group B were instructed to apply their assigned test product every other day in the evening for the first two weeks of the study and then once daily for subsequent weeks. Consumers should consult each product's prescribing information for recommended dosing.
The study subjects were then evaluated at 4, 8, 12 and 16 weeks for appearance of fine lines and wrinkles, tactile roughness, mottled pigmentation, overall melasma severity, the melasma area severity index (MASI) and skin irritation. Subjects rated the products for aesthetics and feel on the skin.
Full prescribing information for ALUSTRA is available by contacting Medicis.
About Medicis
Medicis is a specialty pharmaceutical company and the leading independent pharmaceutical company in the United States focusing primarily on the treatment of dermatological and pediatric conditions. Medicis develops and markets leading products for major segments within dermatology, including acne, fungal infections, rosacea, hyperpigmentation, photoaging, psoriasis, eczema, skin and skin-structure infections, seborrheic dermatitis, head lice and cosmesis (improvement in the texture and appearance of skin).
Ascent Pediatrics, the Company's wholly owned pediatric subsidiary, markets leading pediatric products for the treatment of asthma and other respiratory inflammatory conditions; acute otitis media or middle ear infections; and an over-the-counter saline nasal mist.
The Company's brands include the prescription brands DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), LUSTRA(R) (hydroquinone), LUSTRA-AF(R) (hydroquinone) with sunscreen, ALUSTRA(TM) (hydroquinone) with retinol, PLEXION(R) (sodium sulfacetamide/sulfur), PLEXION TS(TM) (sodium sulfacetamide/sulfur), TRIAZ(R) (benzoyl peroxide), OMNICEF(R) (cefdinir), ORAPRED(R) (prednisolone sodium phosphate), OVIDE(R) (malathion), LIDEX(R) (fluocinonide), SYNALAR(R) (fluocinolone acetonide) and TOPICORT(R) (desoximetasone); the over-the-counter brands ESOTERICA(R); and BUPHENYL(R) (sodium phenylbutyrate), a prescription product indicated in the treatment of Urea Cycle Disorder.
Except for historical information, this press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. This includes earnings estimates, future financial performance and other matters. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. The Company cannot validate its assumptions of the full impact on its business of the approval of competitive generic versions of the Company's core brands, or any future competitive product approvals that may affect the Company's brands. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Any such projections or statements include the current views of Medicis with respect to future events and financial performance. No assurances can be given, however, that these events will occur or that such results will be achieved and there are a number of important factors that could cause actual results to differ materially from those projected, including the risks and uncertainties normally incident to the pharmaceutical industry, dependence on sales of key products, the uncertainty of future financial results and fluctuations in operating results, dependence on Medicis' strategy including the uncertainty of license payments and/or other payments due from third parties, the timing and success of new product introductions and other risks described from time to time in Medicis' SEC filings including its Annual Report on Form 10-K for the year ended June 30, 2001. Forward-looking statements represent the judgment of Medicis' management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements.
NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. OMNICEF is a registered trademark of Abbott Laboratories, Inc. under a license from Fujisawa Pharmaceutical Co., Ltd. All other marks (or brands) and names are the property of Medicis Pharmaceutical Corporation or its Affiliates. Renova(R) is a registered trademark of Ortho Dermatological, a division of Ortho-McNeil Pharmaceuticals, Inc.
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Contacts: Media Contact: Gerbig, Snell/Weisheimer Larry Meyer, 614/543-6345 lmeyer@gswa.com or Investor Contact: Medicis Pharmaceutical Corporation Libby Ivy, 602/808-3854 investor_relations@Medicis.com