Pivotal in vivo bioequivalence study comparing two formulations of betamethsone OV ointment applied to the skin in healthy male and female volunteers.
- Conditions
- Diprosone OV ointment is indicated for the topical treatment of eczema and psoriasis in children and adults.Skin - Dermatological conditions
- Registration Number
- ACTRN12624000621516
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Males or females
In good general health
Show a vasoconstriction response to a single dose of betamethasone OV ointment
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
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 participant at significant risk
Participation in any drug or medical device study within 30 days of entering this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method in vivo bioequivalence (as summarised by AUEC (Area Under the Effect Curve)) using vasoconstriction.[Blanching will be evaluated objectively using a Minolta CR30 Chromameter. Ointment is applied at various times to 6 sites per arm and assessed at each evaluation time of 0, 2, 4, 6, 19 and 24 hours after ointment removal.]
- Secondary Outcome Measures
Name Time Method Safety[Observing the skin and asking participants if they are experiencing any side effects. Assessed at each evaluation time of 0, 2, 4, 6, 19 and 24 hours after ointment removal.]