Pilot study of a branded (marketed) formulation betamethasone dipropionate called Diprosone® 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.
A pilot dose duration-response study using a branded (marketed) formulation betamethasone dipropionate called Diprosone® ointment to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study and using participants who demonstrate adequate vasoconstriction to topical steroids.
Zenith Technology Corporation Limited
12 participants
Dec 7, 2023
Interventional
Conditions
Summary
To determine the dose duration-response using Diprosone ointment in healthy volunteers who demonstrate adequate vasoconstriction to topical steroids.
Eligibility
Inclusion Criteria7
- 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
- Demonstrates adequate vasoconstriction to the RLD at Screening for Response
Exclusion Criteria12
- Clinically significant hypertension or circulatory disease and any clinically significant illness during the last four weeks prior to the entry into this study.
- Caffeine intake greater than 500 mg per day prior to this study.
- Who have been on a special diet, especially a low salt and/or fluid diet, during the 2 weeks prior to the first study day.
- Use of topical Dermatologic drug therapy on ventral forearms.
- Adverse reactions to topical or systemic corticosteroids.
- Who require shaving of the ventral forearms.
- Use of any vasoactive medication, prescription or over the counter that could modulate blood flow.
- Use of any prescription medication within 2 weeks preceding entry into the study
- Any obvious difference in skin colour between arms or any scarring on the forearms.
- Females who are pregnant or lactating
- Significant medical condition that could in the Investigator's opinion interfere with the study, or put the subject at significant risk
- Participation in any drug or medical device study within 30 days of entering this study
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Interventions
Multiple dose study where each participant attends a single treatment session and receives Diprosone ointment (Betamethasone dipropionate 0.5 mg/g (0.05% w/w)) at various dose durations. The intervention for this trial is the Reference Listed Drug (RLD) of Diprosone ointment (Betamethasone dipropionate 0.5 mg/g (0.05% w/w)). Subjects will be healthy subjects who have shown a vasoconstriction response to a single dose of Diprosone 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 Diprosone ointment and 2 will be untreated control sites. The 8 treated sites (4 on each arm) will have 10 mg of Diprosone ointment applied at various dose-durations at 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours prior to Diprosone ointment removal. The Diprosone 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.
Locations(1)
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ACTRN12623001179628