Analysis of chromameter results obtained from corticosteroid-induced skin blanching assay: comparison of visual and chromameter data

Schwarb, F. P.; Smith, Eric W.; Haigh, J.; Surber, Christian

doi:10.1016/s0939-6411(98)00094-0

Cited by 17 publications

(16 citation statements)

References 13 publications

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“…The assay is also useful for the comparison of the topical availability of corticosteroid formulations containing the same concentration of the same corticosteroid. 22,36 In many studies, the vasoconstriction assay employed visual evaluation of the degree of blanching by trained observers. 37,38 In this study, a chromameter was utilized to quantify and compare the vasoconstrictor effect of DFV.…”

Section: Skin Blanching Assaymentioning

confidence: 99%

“…Although a visual parameter, the quantification by chromameter for the exact determination of degree of skin blanching is a new combination technique, which is also used in this study. 22 Therefore, this study was constructed on two major goals: one was to develop nanoscale formulations of DFV using lecithin/chitosan nanoparticles; and the second was to optimize its efficacy by designing a formulation which can be used safely with minimized potential adverse effects. The optimized nanoparticles were then incorporated into chitosan gels at different ratios in order to enhance the permeation and retention of DFV in skin, in comparison with commercial cream and chitosan gel formulations containing 0.1% DFV.…”

Section: Introductionmentioning

confidence: 99%

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Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

Özcan¹,

Azizoğlu²,

Şenyiğit³

et al. 2013

IJN

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Abstract:The objective of this study was to prepare a suitable formulation for dermal delivery of diflucortolone valerate (DFV) that would maintain the localization in skin layers without any penetration and to optimize efficiency of DFV. Drug-loaded lecithin/chitosan nanoparticles with high entrapment efficiency (86.8%), were successfully prepared by ionic interaction technique. Sustained release of DFV was achieved without any initial burst release. Nanoparticles were also incorporated into chitosan gel at different ratios for preparing a more suitable formulation for topical drug delivery with adequate viscosity. In ex-vivo permeation studies, nanoparticles increased the accumulation of DFV especially in the stratum corneum + epidermis of rat skin without any significant permeation. Retention of DFV from nanoparticle in chitosan gel formulation (0.01%) was twofold higher than commercial cream, although it contained ten times less DFV. Nanoparticles in gel formulations produced significantly higher edema inhibition in rats compared with commercial cream in in-vivo studies. Skin blanching assay using a chromameter showed vasoconstriction similar to that of the commercial product. There were no barrier function changes upon application of nanoparticles. In-vitro and in-vivo results demonstrated that lecithin/chitosan nanoparticles in chitosan gel may be a promising carrier for dermal delivery of DFV in various skin disorders.

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Section: Skin Blanching Assaymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

Özcan¹,

Azizoğlu²,

Şenyiğit³

et al. 2013

IJN

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show abstract

“…Currently, the FDA recommends that the degree of blanching be assessed preferably using a chromameter and/or by visual assessment (5). Several reports have been published on the use of these methods (18)(19) and whilst the chromameter is currently perceived to be the method of choice (5), claims that the use of the visual assessment technique is more accurate have been reported (20)(21)(22)(23). The visual method involves subjective assessment of the intensity of blanching at the application site in comparison to surrounding untreated skin.…”

Section: Introductionmentioning

confidence: 99%

Bioequivalence assessment of topical clobetasol propionate products using visual and chromametric assessment of skin blanching

Skinner

Kanfer

2008

J Pharm Pharm Sci

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-PURPOSE. The assessment of the degree of skin blanching following the application of a formulation containing a topical corticosteroid has been established as a surrogate method for the determination of bioequivalence. In this study, both visual and chromametric assessments have been carried out on two topical creams containing clobetasol propionate (0.05%) and the results from both methods are compared. METHODS. Human subjects (volunteers) were screened using a cream containing 0.05% clobetasol propionate, in order to identify appropriate subjects for inclusion in the study. The study was implemented according to the FDA guidance using both visual and chromameter assessment techniques. Blanching responses were assessed visually by three trained, independent observers and instrumentally using a Chromameter ® . An ED 50 of 36 min was used as the dose duration based upon data previously obtained from a pilot study using the same topical corticosteroid reference product. A visual rating scale of 0-4 and the a-scale readings from the chromameter were used. RESULTS. The visual and chromameter blanching profiles showed similar blanching responses with good correspondence. The 90% confidence intervals for the data from both methods were calculated using Locke's method. When only the data obtained from 23 subjects who were identified as "detectors" (as per FDA guidance) were used, the products fell within the bioequivalence acceptance range of 80-125% using the visual assessment method (99.3-111.6%) whereas the data using a chromameter (86.5-129.3%) were just outside the acceptance limits. However, when all subjects (n=34) were included in the calculations, both the visual (97.9-109.2) and chromameter (90.2-120.7) data fell within the bioequivalence acceptance range. CONCLUSIONS. Whereas visual data indicated bioequivalence using either data from "detectors" or data from all subjects, the chromameter data from "detectors" only indicated bioinequivalence but inclusion of all subject data fell within the acceptance range to be declared bioequivalent.

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“…The chromameter can offer reliable and repeatable results provided that certain drawbacks are avoided such as manipulation of the measuring head of the instrument that can affect the quality of the data produced. Skin compression by the measuring head and the angle alignment of the chromameter play a role in obtaining repeatable data (Taylor et al, 2006;Schwarb et al, 1999;Waring et al, 1993). To obtain optimal results, each subject's assessment site as well as ambient temperature should ideally be controlled.…”

Section: Methodsmentioning

confidence: 99%

“…To obtain optimal results, each subject's assessment site as well as ambient temperature should ideally be controlled. It is also important for the operator to hold the chromameter head in such a way that variation in pressure is avoided (Schwarb et al, 1999). The presence of hair and variations in skin glossiness related to the amount of water and lipid on the skin surface, scarring, uneven skin tone, etc., can influence the data obtained (Fullerton et al, 1996).…”

Section: Methodsmentioning

confidence: 99%

Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms

Kanfer¹

2010

JBB

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Analysis of chromameter results obtained from corticosteroid-induced skin blanching assay: comparison of visual and chromameter data

Cited by 17 publications

References 13 publications

Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

Bioequivalence assessment of topical clobetasol propionate products using visual and chromametric assessment of skin blanching

Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms

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