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A Double-blind Controlled Comparison of Generic and Trade-Name Topical Steroids Using the Vasoconstriction Assay

A Double-blind Controlled Comparison of Generic and Trade-Name Topical Steroids Using the... Abstract • Six generic formulations of five topical steroids were compared for bioequivalence with their trade-name counterparts using an in vivo vasoconstriction assay. Two of six generic formulations were found to show significantly less vasoconstriction than the respective trade-name topical steroids. The issue of generic equivalence of topical steroids is discussed, with particular emphasis on the vagaries of the vasoconstriction assay. (Arch Dermatol. 1991;127:197-201) References 1. Strom BL. Generic drug substitution revisited: special article . N Engl J Med. 1987;316:1456-1462.Crossref 2. Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987;123:1312-1314.Crossref 3. Jackson DB, Thompson C, McCormack JR, Guin JD. Bioequivalence (bioavailability) of generic topical corticosteroids . J Am Acad Dermatol. 1989;20:791-796.Crossref 4. Shah VP, Peck CC, Skelly JP. `Vasoconstriction'—skin blanching—assay for glucocorticoids—a critique . Arch Dermatol. 1989; 125:1558-1561.Crossref 5. Burdick KH. Various vagaries of vasoconstriction . Arch Dermatol. 1974;110:238-242.Crossref 6. Poulsen J, Rorsman H. Ranking of glucocorticoid creams and ointments . Acta Dermatovener (Stockh) . 1980;60:57-62. 7. Barry BW, Woodford R. Comparative bio-availability of proprietary topical corticosteroid preparations: vasoconstrictor assays on thirty creams and gels . Br J Dermatol. 1974;91:323-338.Crossref 8. Kirsch J, Gibson JR, Darley CR, Barth J, Burke CA. Forearm site variation with the corticosteroid vasoconstrictor assay . Br J Dermatol. 1982;106:495.Crossref 9. Barry BW, Woodford R. Activity and bioavailability of topical steroids: in vivo/in vitro correlations for the vasoconstrictor test . J Clin Pharmacol. 1978;3:43-65. 10. Moore-Robinson M, Christie GA. Vasoconstrictor activity of topical corticosteroids: methodology and results . Br J Dermatol. 1970;82:86-92.Crossref 11. Gibson JR, Kirsch JM, Darley CR, Harvey SG, Burke CA, Hanson ME. An assessment of the relationship between vasoconstrictor assay findings, clinical efficacy, and skin thinning effects of a variety of undiluted and diluted corticosteroid preparations . Br J Dermatol. 1984;111:204-212.Crossref 12. Cornell RC, Stoughton RB. Correlation of the vasoconstriction assay and clinical activity in psoriasis . Arch Dermatol. 1985;121:63-67.Crossref 13. McKenzie AW. Percutaneous absorption of steroids . Arch Dermatol. 1962;86:611-614.Crossref 14. Place VA, Velazquez JG, Burdick KH. Precise evaluation of topically applied corticosteroid potency . Arch Dermatol. 1970; 101:532-537.Crossref 15. Poulsen BJ, Burdick K, Bessler S. Paired comparison vasoconstrictor assays . Arch Dermatol. 1974;109:367-371.Crossref 16. Burdick KH, Haleblian JK, Poulsen BJ, Cobner SE. Corticosteroid ointments: comparison by two human bioassays . Curr Ther Res. 1973;15:233-242. 17. Stoughton RB, Wullich K. The same glucocorticoid in brandname products. Does increasing the concentration result in greater topical biologic activity? Arch Dermatol. 1989;125:1509-1511.Crossref 18. McKenzie AW, Atkinson RM. Topical activities of betamethasone esters in man . Arch Dermatol. 1964;89:741-746.Crossref 19. Sefton J, Loder JS, Kyriakopoulos AA. Clinical evaluation of hydrocortisone valerate 0.2% ointment . Clin Ther. 1984;6;282-293. 20. Coldman MF, Lockerbie L, Laws EA. The evaluation of a novel corticosteroid formulation, fluocinonide in `FAPG' base, in the blanching test . Br J Dermatol. 1971;85:573-576.Crossref 21. Stoughton RB, Cornell RC. Review of super-potent topical corticosteroids . Semin Dermatol. 1987;6:72-76. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Dermatology American Medical Association

A Double-blind Controlled Comparison of Generic and Trade-Name Topical Steroids Using the Vasoconstriction Assay

Archives of Dermatology , Volume 127 (2) – Feb 1, 1991

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Publisher
American Medical Association
Copyright
Copyright © 1991 American Medical Association. All Rights Reserved.
ISSN
0003-987X
eISSN
1538-3652
DOI
10.1001/archderm.1991.01680020065006
Publisher site
See Article on Publisher Site

Abstract

Abstract • Six generic formulations of five topical steroids were compared for bioequivalence with their trade-name counterparts using an in vivo vasoconstriction assay. Two of six generic formulations were found to show significantly less vasoconstriction than the respective trade-name topical steroids. The issue of generic equivalence of topical steroids is discussed, with particular emphasis on the vagaries of the vasoconstriction assay. (Arch Dermatol. 1991;127:197-201) References 1. Strom BL. Generic drug substitution revisited: special article . N Engl J Med. 1987;316:1456-1462.Crossref 2. Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987;123:1312-1314.Crossref 3. Jackson DB, Thompson C, McCormack JR, Guin JD. Bioequivalence (bioavailability) of generic topical corticosteroids . J Am Acad Dermatol. 1989;20:791-796.Crossref 4. Shah VP, Peck CC, Skelly JP. `Vasoconstriction'—skin blanching—assay for glucocorticoids—a critique . Arch Dermatol. 1989; 125:1558-1561.Crossref 5. Burdick KH. Various vagaries of vasoconstriction . Arch Dermatol. 1974;110:238-242.Crossref 6. Poulsen J, Rorsman H. Ranking of glucocorticoid creams and ointments . Acta Dermatovener (Stockh) . 1980;60:57-62. 7. Barry BW, Woodford R. Comparative bio-availability of proprietary topical corticosteroid preparations: vasoconstrictor assays on thirty creams and gels . Br J Dermatol. 1974;91:323-338.Crossref 8. Kirsch J, Gibson JR, Darley CR, Barth J, Burke CA. Forearm site variation with the corticosteroid vasoconstrictor assay . Br J Dermatol. 1982;106:495.Crossref 9. Barry BW, Woodford R. Activity and bioavailability of topical steroids: in vivo/in vitro correlations for the vasoconstrictor test . J Clin Pharmacol. 1978;3:43-65. 10. Moore-Robinson M, Christie GA. Vasoconstrictor activity of topical corticosteroids: methodology and results . Br J Dermatol. 1970;82:86-92.Crossref 11. Gibson JR, Kirsch JM, Darley CR, Harvey SG, Burke CA, Hanson ME. An assessment of the relationship between vasoconstrictor assay findings, clinical efficacy, and skin thinning effects of a variety of undiluted and diluted corticosteroid preparations . Br J Dermatol. 1984;111:204-212.Crossref 12. Cornell RC, Stoughton RB. Correlation of the vasoconstriction assay and clinical activity in psoriasis . Arch Dermatol. 1985;121:63-67.Crossref 13. McKenzie AW. Percutaneous absorption of steroids . Arch Dermatol. 1962;86:611-614.Crossref 14. Place VA, Velazquez JG, Burdick KH. Precise evaluation of topically applied corticosteroid potency . Arch Dermatol. 1970; 101:532-537.Crossref 15. Poulsen BJ, Burdick K, Bessler S. Paired comparison vasoconstrictor assays . Arch Dermatol. 1974;109:367-371.Crossref 16. Burdick KH, Haleblian JK, Poulsen BJ, Cobner SE. Corticosteroid ointments: comparison by two human bioassays . Curr Ther Res. 1973;15:233-242. 17. Stoughton RB, Wullich K. The same glucocorticoid in brandname products. Does increasing the concentration result in greater topical biologic activity? Arch Dermatol. 1989;125:1509-1511.Crossref 18. McKenzie AW, Atkinson RM. Topical activities of betamethasone esters in man . Arch Dermatol. 1964;89:741-746.Crossref 19. Sefton J, Loder JS, Kyriakopoulos AA. Clinical evaluation of hydrocortisone valerate 0.2% ointment . Clin Ther. 1984;6;282-293. 20. Coldman MF, Lockerbie L, Laws EA. The evaluation of a novel corticosteroid formulation, fluocinonide in `FAPG' base, in the blanching test . Br J Dermatol. 1971;85:573-576.Crossref 21. Stoughton RB, Cornell RC. Review of super-potent topical corticosteroids . Semin Dermatol. 1987;6:72-76.

Journal

Archives of DermatologyAmerican Medical Association

Published: Feb 1, 1991

References