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

Authors: Franz T.J.; Parsell D.A.; Halualani R.M.; Hannigan J.F.; Kalbach J.P.; Ma .; Harkonen W.S.

Source: International Journal of Dermatology, Volume 38, Number 8, 1 August 1999 , pp. 628-632(5)

Publisher: Wiley-Blackwell

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Abstract:

Abstract

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.

Language: English

Document Type: Miscellaneous

Publication date: 1999-08-01