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
Abstract:
AbstractBackground: 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 hypothalamicpituitaryadrenal (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 investigators 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
- In this: publication
- By this: publisher
- In this Subject: Dermatology
- By this author: Franz T.J. ; Parsell D.A. ; Halualani R.M. ; Hannigan J.F. ; Kalbach J.P. ; Ma . ; Harkonen W.S.

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