A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay

Mometasone furoate, a potent glucocorticoid (class III) with a favorable benefit/risk ratio, has emerged as a standard medication for the treatment of inflammatory skin disorders. The purpose of the investigation presented here was to determine the noninferiority of a topical mometasone formulation, a light cream (O/W 60/40 emulsion) with mometasone furoate 0.1% (water content of 33%) versus marketed comparators. Using the vasoconstrictor assay, a strong blanching effect of the new cream (called Mometasone cream) comparable to that of a mometasone comparator, a fatty cream with mometasone furoate 0.1%, could be demonstrated. Thus, the topical bioavailability of the active ingredient mometasone furoate (0.1%) was regarded to be similar for Mometasone cream and the mometasone comparator. Using the psoriasis plaque test, a strong antipsoriatic effect comparable to that of the mometasone comparator was found for Mometasone cream after 12 days of occlusive treatment. A nearly identical reduction in the mean infiltrate thickness and similar mean AUC values were noted with both formulations confirmed by clinical assessment data. The noninferiority of Mometasone cream to its active comparator with respect to the AUC of change to baseline in infiltrate thickness was demonstrated. Both medications were well tolerated. Overall, Mometasone cream and the mometasone comparator showed similar efficacy and tolerability. Mometasone cream, in addition to its high potency and good tolerability, provides the properties of a light cream, which might make this new medication particularly suitable for application on acutely inflamed and sensitive skin.

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“…The efficacy of a glucocorticoid formulation is considerably influenced by its vehicle [12] . This also applies to mometasone furoate [8] .…”

Section: Introductionmentioning

confidence: 99%

Bioavailability, Antipsoriatic Efficacy and Tolerability of a New Light Cream with Mometasone Furoate 0.1%

Körting

Schöllmann

Willers

et al. 2012

Skin Pharmacol Physiol

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“…In order to assess the vasoconstrictive activity of test preparations versus placebo (vehicle of cream), 50 l of each preparation were applied occlusively for 2 h (pilot study) or 24 h (main study) on outlined areas Chambers according to the randomization plan. Vasoconstriction was evaluated using a subjective rating scale (Olsen vasoconstriction score: 0 = no reaction; 1 = weak; 2 = moderate; 3 = strong vasoconstriction) [2], and blanching effect was determined by colorimetry (chromametry). Assessment of vasoconstriction was performed before treatment, and 0.5, 4, 6 and 24 h after treatment (observation period) using a subjective rating scale (Olsen vasoconstriction score) and measuring the colorimetric parameter a * (redness) by use of the Chroma-Meter (Minolta company, Ahrensburg, Germany).…”

Section: Test Proceduresmentioning

confidence: 99%

“…In 1962, McKenzie and Stoughton [1] reported the vasoconstrictor assay for measuring the potency of topically applied corticosteroids. Additionally, clinical studies have indicated that a correlation exists between the anti-inflammatory activity of topical corticosteroids and the amount of vasoconstriction [2,3] . The standardization and reproducibility of vasoconstrictor assay was described by Elsner [4] , using a chromametric method.…”

Section: Introductionmentioning

confidence: 99%

Assessment of Topical Corticosteroid Activity Using the Vasoconstriction Assay in Healthy Volunteers

Görne¹,

Greif²,

Metzner³

et al. 2006

Skin Pharmacol Physiol

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Objective and Design: The aim of the study was to evaluate the vasoconstrictive activity of four new galenic preparations of hydrocortisone and to compare it with concentration-equivalent reference preparations. The study comprised two study phases: the pilot study phase and the main study phase. During open, nonrandomized pilot study, the optimal administration period was tested. The main study was performed in a randomized, double-blind intraindividual comparative design. Subjects: Twenty male and female volunteers with healthy skin who responded to topically applied clobetasol-17-propionate before entering the trial participated in this study. Treatment: All subjects received the same treatments. The test preparations new galenic formulation (NGF) hydrocortisone 0.25% cream, NGF hydrocortisone acetate 0.25% cream, NGF hydrocortisone 0.5% cream, and NGF hydrocortisone 1.0% cream were compared with the respective reference preparations Soventol® hydrocortisone (hydrocortisone acetate 0.25%), Hydroderm HC 0.5% cream (hydrocortisone 0.5%), Hydrogalen® cream (hydrocortisone 1.0%) and placebo (vehicle of test preparations). Method: The topical preparations were applied occlusively for 2 h (pilot study) or 24 h (main study) on outlined areas (5 × 5 cm with a distance of 3 cm) of both forearms (4 areas for each). Assessment of vasoconstriction was performed before treatment, and 0.5, 4, 6 and 24 h after treatment (observation period) using a subjective rating scale (OLSEN vasoconstriction score) and measuring the colorimetric parameter a* (redness) by use of the Chroma-Meter (Minolta company, Ahrensburg, Germany). Results: A significant vasoconstriction (positive blanching effect) was measured by use of chromametry for test preparations hydrocortisone 0.25% cream, hydrocortisone 0.5% cream, hydrocortisone 1.0% cream and for the reference preparation Hydrogalen cream compared to placebo 30 min after the end of treatment. In contrast, the reference preparations Soventol hydrocortisone and Hydroderm HC 0.5% did not differ significantly from placebo 30 min after treatment. No statistically significant effect of all formulations was observed 4–24 h after treatment in comparison with placebo. Conclusions: The vasoconstrictive efficacy of test preparations was mostly stronger than the concentration-equivalent reference preparations. This effect was achieved by use of new galenics of test preparations resulting in enhanced skin penetration and improved efficiency. No unwanted side effects were observed during the course of the study despite increased efficacy of the topically applied test preparations.

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“…6 Clinical studies have established that the intensity of skin blanching produced by the topical application of corticosteroids is usually correlated with clinical efficacy, and can be used as a valuable bioassay to determine the bioavailability of steroids from topical vehicles. [6][7][8][9][10] The term bioavailability here refers to the relative absorption efficiency as determined by the release of the steroid from the formulation, followed by its penetration through the stratum corneum and viable epidermis into the dermis to produce the characteristic vasoconstrictor effect. 11 Hydrocortisone, as a weak steroid, is rarely associated with undesirable effects and is the steroid of choice for infants, the face, mucous membranes and for individuals with sensitive skin, or possibly when the steroid-responsive condition is not severe.…”

Section: Introductionmentioning

confidence: 99%

Increased bioavailability of hydrocortisone dissolved in a cream base

Greive¹,

Barnes²

2013

Aust J Dermatology

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A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay

Cited by 11 publications

References 0 publications

Bioavailability, Antipsoriatic Efficacy and Tolerability of a New Light Cream with Mometasone Furoate 0.1%

Bioavailability, Antipsoriatic Efficacy and Tolerability of a New Light Cream with Mometasone Furoate 0.1%

Assessment of Topical Corticosteroid Activity Using the Vasoconstriction Assay in Healthy Volunteers

Increased bioavailability of hydrocortisone dissolved in a cream base

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