Pilot study of a branded (marketed) formulation methylprednisolone aceponate called Advantan ointment applied to the skin in healthy male and female volunteers to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study.

INTERVENTION: Multiple dose study where each participant attends a single treatment session and receives Advantan ointment (methylprednisolone aceponate 1 mg/g (0.1% w/w)) at various dose durations. The intervention for this trial is the Reference Listed Drug (RLD) of Advantan ointment (methylprednisolone aceponate 1 mg/g (0.1% w/w)) . Subjects will be healthy subjects who have shown a vasoconstriction response to a single dose of Advantan ointment. All applications, measurements and assessments will be carried out at the Zenith Clinical Site where all participants will be confined and monitored for the duration of the study i.e. a 2 day period. There will be 12 sites in total (6 on each arm) where 4 sites will be treated with the ointment and 2 will be untreated control sites. The 8 treated sites (4 on each arm) will have 10 mg of ointment applied at various dose‐durations at 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours prior to ointment removal. The ointment is then removed from all sites and the Chromameter measurements for the pharmacodynamic responses of the topical corticosteroid will be carried out at 0, 2, 4, 6, 19 and 24 hours following removal. Subjects who meet the inclusion and exclusion criteria will be included in this study. Pre and post study laboratory tests will be performed along with an ECG and medical evaluation. A follow up visit will also be completed to assess for safety. CONDITION: Advantan ointment is indicated for the topical treatment of eczema and psoriasis in children and adults.; ; Advantan ointment is indicated for the topical treatment of eczema and psoriasis in children and adults. Skin ‐ Dermatological conditions PRIMARY OUTCOME: To determine the D1 parameter of Advantan ointment (methylprednisolone aceponate 0.1%w/w) using the Minolta Chromameter. The values will be used to measure the degree of colour change of each treatment site using a formulation that will be calculated and plotted against time.[Cream Applications: 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours; ; Skin evaluations: Time 0, 2, 4, 6, 19 and 24 hours following cream removal] To determine the D2 parameter of Advantan ointment (methylprednisolone aceponate 0.1%w/w) using the Minolta Chromameter. The values will be used to measure the degree of colour change of each treatment site using a formulation that will be calculated and plotted against time.[Cream Applications: 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours; ; Skin evaluations: Time 0, 2, 4, 6, 19 and 24 hours following cream removal] To determine the ED50 parameter of Advantan ointment (methylprednisolone aceponate 0.1%w/w) using the Minolta Chromameter. The values will be used to measure the degree of colour change of each treatment site using a formulation that will be calculated and plotted against time.[Cream Applications: 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours; ; Skin evaluations: Time 0, 2, 4, 6, 19 and 24 hours following cream removal] SECONDARY OUTCOME: Not applicable for this study[Not applicable for this study] INCLUSION CRITERIA: Males or females In good general health Aged between 18‐55 years of age inclusive BMI between 18 and 33 inclusive Laboratory tests within normal ranges or assessed not significant by the Clinical Investigator Normal ECG