Betamethasone valerate foam 0.12%: a novel vehicle with enhanced delivery and efficacy.
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.
Franz
T J
TJ
Connetics Corporation, Palo Alto, California 94303, USA. franz-t@connetics.com
Parsell
D A
DA
Halualani
R M
RM
Hannigan
J F
JF
Kalbach
J P
JP
Harkonen
W S
WS
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D001624:Betamethasone Valerate / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D001682:Biological Availability; D002102:Cadaver; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy*; D012016:Reference Values; D012680:Sensitivity and Specificity; D012869:Skin Absorption; D018709:Statistics, Nonparametric
D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; D005938:Glucocorticoids; D014677:Pharmaceutical Vehicles; D001624:Betamethasone Valerate