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Vanos

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Vanos

Vanos

CLINICAL PHARMACOLOGY

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of VANOS Cream in corticosteroid responsive dermatoses is unknown.

Pharmacodynamics

Vasoconstrictor studies performed with VANOS Cream in healthy subjects indicate that it is in the super-high range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

Application of VANOS Cream twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10-50% BSA, mean 19.6% BSA) and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2-10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH1-24) [see WARNINGS AND PRECAUTIONS].

HPA-axis suppression following application of VANOS Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to < 18 years of age with atopic dermatitis (mean BSA range 34.6 % -40.0 %). HPA-axis suppression was observed in 4 patients in the twice daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see WARNINGS AND PRECAUTIONSand Use In Specific Populations].

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Clinical Studies

Two adequate and well-controlled efficacy and safety studies of VANOS Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with VANOS Cream for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.

Table 2: Plaque-type Psoriasis in Adults

  VANOS Cream, once daily
(n=107)
Vehicle, once daily
(n=54)
VANOS Cream, twice daily
(n=107)
Vehicle, twice daily
(n=55)
Subjects cleared 0 (0) 0 (0) 6 (6%) 0 (0)
Subjects achieving treatment success* 19 (18%) 4 (7%) 33 (31%) 3 (5%)
*Cleared or almost cleared

Table 3: Atopic Dermatitis in Adults

  VANOS Cream, once daily
(n=109)
Vehicle, once daily
(n=50)
VANOS Cream, twice daily
(n=102)
Vehicle, twice daily
(n=52)
Subjects cleared 11 (10%) 0 (0) 17 (17%) 0 (0)
Subjects achieving treatment success* 64 (59%) 6 (12%) 58 (57%) 10 (19%)
*Cleared or almost cleared

No efficacy studies have been conducted to compare VANOS (fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including fluocinonide cream 0.05%.

Last reviewed on RxList: 4/4/2012
This monograph has been modified to include the generic and brand name in many instances.

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