Betamethasone valerate foam 0.12%: a novel vehicle with enhanced delivery and efficacy

• Published in: International journal of dermatology 1999-08, Vol.38 (8), p.628-632
• Main Authors: Franz, Thomas J., Parsell, Dawn A., Halualani, Roger M., Hannigan, John F., Kalbach, Jacqueline P., Ma, ., Harkonen, W. Scott
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adolescent; Adult; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - pharmacokinetics; Betamethasone Valerate - administration & dosage; Betamethasone Valerate - pharmacokinetics; Biological and medical sciences; Biological Availability; Cadaver; Dosage Forms; Double-Blind Method; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Medical sciences; Middle Aged; Pharmaceutical Vehicles; Pharmacology. Drug treatments; Psoriasis - diagnosis; Psoriasis - drug therapy; Reference Values; Sensitivity and Specificity; Skin Absorption; Skin, nail, hair, dermoskeleton; Statistics, Nonparametric
• ISSN: 0011-9059; 1365-4632
• DOI: 10.1046/j.1365-4362.1999.00782.x

Background: A new topical formulation of betamethasone valerate (BMV) with enhanced dermal penetration has been developed. Objective: These studies were designed to evaluate: (1) the relative bioavailability of BMV foam, and (2) the safety and efficacy of BMV foam in the treatment of scalp psoriasis as compared to a lotion formulation of BMV and placebo. Methods: Safety and efficacy were evaluated in a randomized, multicenter, double‐blind, active‐and placebo‐controlled trial in adult patients with moderate to severe scalp psoriasis. A separate study in 18 patients was conducted to evaluate the potential for suppression of the hypothalamic–pituitary–adrenal (HPA) axis. Relative bioavailability was measured using the human cadaver skin model. Results: 72% of patients using BMV foam were clear or almost clear of disease at the end of 28‐days of treatment as judged by the investigator’s global assessment of response. Only 47% of BMV lotion patients and 21% of placebo showed a similar level of response. There was no evidence of increased toxicity or HPA‐axis suppression for BMV foam, but assessment of relative bioavailability showed BMV penetration into the skin to be more than two‐fold greater than from BMV lotion. Conclusions: A novel foam formulation with enhanced BMV bioavailability has been shown to be of increased efficacy in the treatment of scalp psoriasis without an associated increase in toxicity.