Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects

Exclusion Criteria

• •Subject has a past or current medical condition that might significantly affect pharmacodynamic response to topical corticosteroids.
• •Subject has diabetes mellitus, clinically significant hypertension or circulatory disease.
• •Subject is taking any medication on a regular basis that could modulate blood flow (constrictor or dilator), with the exception of any prescribed birth control method and hormone replacement therapy. Examples of such drugs include nitroglycerin, anti- hypertensives, antihistamines, NSAIDs, aspirin, phenylpropanolamine, phentolamine or any other medications deemed inappropriate by the Investigator.
• •Subject is planning to use any exclusionary over-the-counter (OTC) medications within 48 hours prior to or throughout the study that could modulate vascular blood flow.
• •Subject intends to start, stop or change dose of any prescription or OTC medication within 48 hours prior to or throughout the study. Acetaminophen may be administered, if needed.
• •Subject has used prescription or OTC topical medications on the ventral forearms within 1 month prior to study conduct.
• •Subject has a history of sensitivity/allergy to the ingredients found in the test formulations or has a history of adverse reactions to topical or systemic corticosteroids.
• •Subject has a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
• •Subject has a history of significant skin conditions or disorders, for example, psoriasis, atopic dermatitis, etc.
• •Subject has a history of significant dermatologic cancers, for example, melanoma or squamous cell carcinoma. Basal cell carcinomas that were superficial and do not involve the investigative site are acceptable.
• •Subject has an obvious difference in skin color between arms or the presence of a skin condition, scar tissue, tattoo or coloration that would interfere with placement of test sites, their assessments, their reaction to drug or could compromise the safety of the subject.
• •Subject has used topical medications on the ventral forearms within 1 month prior to dosing.
• •Subject has used a tobacco product within 14 days of study conduct.
• •Subject has a clinically significant history of drug abuse or alcoholism.
• •Subject has donated or received blood within 30 days prior to dosing.
• •Subject's caffeine intake is greater than 500 mg per day (1 cup of coffee contains approximately 85 mg of caffeine).
• •Subject is unwilling to abstain from alcohol or caffeine for 48 hours prior to and throughout the study.
• •(Females only): Subject is pregnant or lactating.
• •Subject has participated in another investigational drug, medical device, or biologics study within 30 days prior to dosing.