AusPAR: Clobetasol propionate - Therapeutic Goods Administration

Therapeutic Goods AdministrationThe PCE’s comments regarding the measurement of the recommended dose of ClobexShampoo have been noted. The sponsor commits to add a measuring device with ClobexShampoo. The sponsor proposes to address this concern by means of a variationsubmission to the TGA in early 2013. The Dosage and Administration information in the PIand CMI will be amended at that time to reflect this change.The section “Use in children” in the Product Information has been amended.3. Clinical dataSubjects aged from 12 to 17 years old have been included in three efficacy studies. Studies18075 and 18076 were the two vehicle-controlled Phase III studies in subjects aged 12years and older with moderate to severe scalp psoriasis. Study 2638 was an activecontrolledPhase III study and also enrolled subjects 12 years and older with moderate tosevere scalp psoriasis. The table below summarises the number of patients aged from 12to 17 years old receiving clobetasol propionate (CP) shampoo in each study.Table 3. Study detailsIn the efficacy clinical development program, 6 subjects from 12 to 17 years old wereexposed to CP shampoo in efficacy studies. One 10 year old subject was also enrolled inStudy 2638 (protocol violation) and exposed to CP shampoo. Safety study 18070 wasspecifically designed to address the risk of HPA axis suppression in the 12 to 17 yearspopulation where 19 subjects were exposed.The section “Use in children” of the Product Information has been amended as follows:“The experience in the paediatric population is limited. CLOBEX shampoo is notrecommended for use in children and adolescents below 18 years of age. Because of a higherratio of skin surface area to body mass, children are at a greater risk than adults of HPA axissuppression when they are treated with topical corticosteroids. They are also at greater riskof adrenal insufficiency after withdrawal of treatment, and of Cushing’s syndrome while ontreatment”Off-treatment durationPsoriasis is a chronic, relapsing, inflammatory skin disease. Treatment of localisedpsoriasis such as scalp psoriasis usually relies on topical treatments. The initial clearingphase mostly requires the use of high potency corticosteroids such as clobetasolpropionate (CP). Once a marked improvement is observed, the strength of thecorticosteroid and/or the frequency of application are gradually reduced over severalweeks (transition phase), until complete clearance. At this time, the treatment is oftendiscontinued. Patients are usually instructed to resume treatment as soon as the diseasereappears. Alternatively, a maintenance treatment may be recommended to increase theduration of the remission, particularly in patients who experience frequent relapses.AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5Final 22 May 2013Page 39 of 45