AusPAR: Clobetasol propionate - Therapeutic Goods Administration

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Therapeutic Goods AdministrationTopical treatment of moderate to severe scalp psoriasis in adults.with the following dosing regimen: (Abridged)“Clobex Shampoo: Should be applied directly on dry scalp once daily taking care towell cover and massage the lesions. An amount equivalent to approximately one anda half teaspoons (approximately 7.5 mL) per application is sufficient to cover all thescalp. Clobex shampoo should be then kept in place without covering for 15minutesbefore rinsing....Treatment duration should be limited to a maximum of 4 weeks. As soon as clinicalresults are observed, applications should be spaced out or replaced, if needed, by analternative treatment. .Repeated courses of Clobex Shampoo may be used to control exacerbations providedthe patient is Under regular supervision”.Regulatory statusThe following table summarises the international regulatory status for this product.Table 1. Summary of the international regulatory status of Clobex shampooCountry*LocalProductNameRegistrationDateIndicationCanadaClobexShampoo29 July 2004Clobex Shampoo (clobetasol propionateshampoo, 0.05%) is a super‐high potent topicalcorticosteroid formulation indicated for the reliefof the inflammatory and pruritic manifestationsof moderate to severe forms of scalp psoriasis insubjects 18 years of age and older.NewZealandClobexShampoo6 September2007Topical treatment of moderate to severe scalppsoriasis.Sweden Clobex 500mikrogram/g schampo16 February2007Topical treatment of moderate to severe scalppsoriasis.SwitzerlandClobexShampoo13 September2007Psoriasis and recalcitrant eczemas of the scalp inadults from 18 years of age.Maintenance treatment for prevention ofrecurrence.UnitedKingdomEtrivex 500micrograms/g shampoo26 February2007Topical treatment of moderate to severe scalppsoriasis.USAClobex(clobetasolpropionate)Shampoo,0.05%5 February2004Clobex Shampoo is a super‐high potent topicalcorticosteroid formulation indicated for thetreatment of moderate to severe forms of scalppsoriasis in patients 18 years of age and older.*The registration of this product in Europe covers 19 countries.AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5Final 22 May 2013Page 6 of 45
Therapeutic Goods AdministrationProduct InformationThe approved Product Information (PI) current at the time this AusPAR was prepared canbe found as Attachment 1.List of abbreviationsAEANCOVAANOVABPBSACCCPSCPSHDAEDLQIHPAIGAIOPITTLLOQLOCFMEDminNSAIDODSPOQL-12PUVASAESDSESOCTDSSTEECTPSadverse eventanalysis of covarianceanalysis of varianceblood pressurebody surface areaCyclocort Creamclobetasol propionate sprayclobetasol propionate shampoodiscontinuation due to AEDermatology Life Quality Indexhypothalamic pituitary axisInvestigator Global Severity Assessmentintraocular pressureintention to treatlower limit of quantificationlast observation carried forwardMinimal erythema doseminutenon-steroidal anti-inflammatory drugoverall disease severityKoo Menter Psoriasis Index 12-Item Psoriasis Quality of LifeQuestionnairepsoralen plus ultraviolet lightserious adverse eventstandard deviationstandard errorsystem organ classificationtotal disease severity scoreTemovate E® emollient creamtarget plaque severity95% CI 95% confidence intervalAusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5Final 22 May 2013Page 7 of 45
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AusPAR: Clobetasol propionate - Therapeutic Goods Administration

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