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A Novel Formulation of Mometasone Furoate in Psoriasis Patients: a Multicenter, Randomized, Double-Blind Clinical Study

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A Novel Formulation of Mometasone Furoate in Psoriasis Patients: a Multicenter, Randomized, Double-Blind Clinical Study Adv Ther DOI 10.1007/s12325-013-0033-4 ORIGINAL RESEARCH A Novel Formulation of Mometasone Furoate in Psoriasis Patients: A Multicenter, Randomized, Double-Blind Clinical Study Mats Berg • A˚ ke Svensson • Jan Faergemann To view enhanced content go to www.advancesintherapy.com Received: March 26, 2013 Ó Springer Healthcare 2013 ABSTRACT formulation, EloconÒ (Merck [Schering Plough], Whitehouse Station, New Jersey, USA). This Introduction: Further formulations of novel formulation of mometasone furoate was mometasone furoate are needed for treatment examined in a vasoconstrictor assay comparing of patients with plaque psoriasis to meet its efficacy with that of Elocon. Subsequently, individual patient preferences. This has the new formulation was tested in a motivated the development of OvixanÒ multicenter, randomized, double-blind clinical (Galencia, Malmoe, Sweden), a formulation of study in patients with plaque psoriasis. mometasone furoate with different cosmetic Methods: Healthy volunteers were included in properties than the commonly used the vasoconstrictor study. The treatments were randomly assigned to test fields on the forearms. The test fields were gently cleaned EudraCT numbers 2008-003823-21 and 2009-016827-72. after treatment for 6 h. Skin color was measured during the following 24 h and area under the M. Berg time curve was calculated. The clinical efficacy Department of Dermatology, Ma¨larsjukhuset, 63188 Eskilstuna, Sweden and tolerance of Ovixan was as compared to A˚ . Svensson that of Elocon and their vehicles in a double- Department of Dermatology, MAS University blind study in patients with plaque psoriasis. Hospital, 20502 Malmo¨, Sweden Patients with four symmetrically placed lesions J. Faergemann (&) on the arms or the legs were treated for 6 weeks. Department of Dermatology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden Primary endpoint was the change from baseline e-mail: [email protected] of the Total Severity Sign score for each treated lesion. The cosmetic characteristics of the two test preparations were assessed by an independent cosmetological institute. Enhanced content for Advances in Therapy Results: Ovixan was shown to have skin articles is available on the journal web site: www.advancesintherapy.com blanching potency almost identical to the 123 Adv Ther vasoconstrictor potency of Elocon. Clinical high potency with low systemic availability equivalence of Ovixan to Elocon was after topical administration [1]. The resulting demonstrated in the clinical study of the low systemic toxicity leads to an improved risk– efficacy in patients with plaque psoriasis. benefit ratio as compared to the previous A professional testing team clearly moderately potent topical corticosteroids documented the cosmetic superiority of [2–4]. Owing to its potency, its low Ovixan as compared to Elocon. percutaneous penetration, low systemic Conclusion: The results of the investigations toxicity, and low risk of sensitization, topically show that Ovixan is equipotent to the applied mometasone furoate cream has commonly used formulation Elocon. However, emerged as a commonly used formulation for the cosmetic properties are in favor of Ovixan. the treatment of plaque psoriasis and other The effect of the cosmetic differences on patient inflammatory skin disorders. preferences and patient adherence to prescribed The activity of mometasone furoate and treatment has to be investigated in further other corticosteroids is influenced by the studies. pharmaceutical formulation used. Penetration enhancers, lipid content, and stability have Keywords: Cosmetic acceptability; Elocon; been found to influence the activity of a Mometasone furoate; Ovixan; Randomized topical formulation [3, 5–7]. Of even higher clinical study; Plaque psoriasis; Total Severity importance for the efficacy of a corticosteroid Sign score; Vasoconstrictor assay formulation is the degree of patient compliance. Adherence to topical medication is considered a major problem in the treatment INTRODUCTION of psoriasis [8, 9]. Prescribing therapy in line with patient preference for treatment vehicle Corticosteroids are one of the most commonly may be a key factor for treatment success used topical treatments of plaque psoriasis. The [10, 11]. The cosmetic aspect of treatment has action of corticosteroids is wide ranging, been found to have a major impact on the including anti-inflammatory and patients’ compliance to treatment [12]. The immunosuppressive effects, which are at least main reasons given by the patients in this partly related to the inhibition of the release of pan-European study for not complying with various cytokines. The long-term use of topical prescribed treatment were lack of efficacy and corticosteroids has earlier been limited by both poor cosmetic characteristics of the treatments. topical and systemic side effects with skin The patients expressed their desire to have less atrophy and suppression of the pituitary greasy, sticky, and smelly treatments with high secretion of adrenocorticotrophic hormone efficacy to be more compliant [12]. Those (ACTH) being of particular concern. Therefore, results are in line with the results from an much effort has been focused on developing earlier questionnaire study in patients with corticosteroids for topical use where high- psoriasis [13]. Of the 692 patients, only 26% strength local effect is combined with low preferred ointments, clearly fewer than the 43% systemic availability. The development of who preferred the less greasy cream mometasone furoate has been a significant formulations. This underlines the need for a advancement. This corticosteroid combines variety of improved formulations of 123 Adv Ther mometasone furoate and other corticosteroids commonly used mometasone formulation. in order to meet varying patient preferences Elocon is a water in oil (w/o) emulsion, where [13]. white soft paraffin is the main component of The need for further formulations of the continuous oil phase, accounting for mometasone furoate has triggered approximately 54% (m/m). The aqueous phase, pharmaceutical development work. Recently, containing only approximately 3% (m/m) water the development of a less fatty cream with of the total composition, is dispersed in the mometasone furoate 0.1% has been reported continuous oil phase. In this formulation, [14, 15]. In parallel, another cream formulation, hexylene glycol is used to dissolve mometasone Mometasone 0.1% cream Galenica (in the furoate. following text referred to as OvixanÒ [Galencia, Malmoe, Sweden]), has been Vasoconstrictor Assay developed with different cosmetic properties than the commonly used, commercially The vasoconstrictor effect of Ovixan and other available mometasone formulation, EloconÒ study preparations and of comparators was (Merck [Schering Plough], Whitehouse Station, examined by the dermatological contract New Jersey, USA). The authors report here the research organization, bioskin GmbH, results from a multicenter, randomized, double- Hamburg, Germany. The study protocol was blind clinical study of Ovixan in patients with approved by the Ethical committee of the mild-to-moderate plaque psoriasis. The clinical Hamburg Medical Council. The study was study of the efficacy and safety of Ovixan was performed in accordance with the ‘‘Somerset preceded by a comparative investigation of the West’’ Declaration of Helsinki (October 1996) as vasoconstrictor potency of this novel cream as revised in 2000, as well as German regulations. examined in the vasoconstrictor assay [16, 17]. The International Conference on The aim of the investigations was to investigate Harmonization (ICH) guideline for Good if Ovixan was clinically equivalent to Elocon. Clinical Practice (GCP) (January 1997) was observed. Informed consent was obtained from all patients for being included in the study. The MATERIALS AND METHODS trial has the EudraCT number 2008-003823-21. The study was conducted between August 27 Ovixan 1 mg/g Cream and September 9 2008. Healthy male and female volunteers from Ovixan is a cream containing 1 mg/g Hamburg, Germany, with healthy skin and mometasone furoate. Ovixan is an oil in water demonstrated adequate vasoconstriction after (o/w) emulsion with coconut oil dispersed in treatment with topical corticosteroids were the continuous water phase. Coconut oil selected according to defined inclusion and accounts for approximately 8% (m/m) and exclusion criteria, and were included in water for approximately 50% (m/m) of the the study. Exclusion criteria included total cream composition. Propylene glycol is immunocompromised patients, the use of a used as solvent for mometasone furoate. potent topical corticosteroid formulation The composition of Ovixan is distinctly within the last 4 weeks, systemic use of anti- different from the composition of Elocon, a inflammatory drugs within the last 2 months, 123 Adv Ther and non-reliable patients, e.g., due to drug or performed for both active study preparations alcohol abuse. This single-center, vehicle- and corresponding active ingredient-free controlled study was double-blind for the vehicles. The overall significance level of study preparations and observer-blind for the P \0.05 could be kept for each active study comparators with random assignments of the preparation with this ordered test procedure. treatments to test fields on the right and left forearm. All included subjects completed the The Multicenter, Randomized, Double- study and were included in the intent-to-treat Blind Clinical Study of
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