Tazarotene cream in the treatment of psoriasis: Two multicenter, double-blind, randomized, vehicle-controlled studies of the safety and efficacy of tazarotene creams 0.05% and 0.1% applied once daily for 12 weeks

Gerald D. Weinstein, John Y M Koo, Gerald G. Krueger, Mark G. Lebwohl, Nicholas J. Lowe, M. Alan Menter, Deborah A. Lew-Kaya, John Sefton, John R. Gibson, Patricia S. Walker, Ernest Ast, Jerry Bagel, Debra L. Breneman, Ross D. Bright, Steven A. Davis, Madeleine Duvic, Drore Eisen, Steven R. Feldman, Virginia C. Fiedler, Richard FitzpatrickDavid P. Fivenson, Bernard S. Goffe, Jon Hanifin, Steven R. Hong, Terry M. Jones, Steven E. Kempers, Stephen J. Kraus, Paul A. Krusinski, James J. Leyden, J. Michael Maloney, Bruce H. Miller, David M. Pariser, Tania J. Phillips, Blas Reyes, Owen Reynolds, Toivo E. Rist, Glenn G. Russo, Joel S. Shavin, Daniel Stewart, Leonard J. Swinyer, Eduardo H. Tschen, David I. Wolf

Research output: Contribution to journalArticle

88 Citations (Scopus)

Abstract

Background: Tazarotene in a gel formulation is widely used in the treatment of psoriasis. Objective: To determine the efficacy and safety of tazarotene 0.1% and 0.05% creams in the treatment of psoriasis. Methods: A total of 1303 patients participated in 2 clinical trials. Patients applied tazarotene creams 0.1% and 0.05% or vehicle once daily to all psoriatic lesions for 12 weeks followed by a 12-week posttreatment period. Results: Both creams were significantly more effective than vehicle on the basis of an overall assessment of psoriasis, a global response to treatment, and reduction in plaque elevation and scaling. Therapeutic effect was maintained during the posttreatment period. Common adverse events included signs and symptoms of skin irritation. Conclusion: Tazarotene creams were associated with significant reductions in the severity of the clinical signs of psoriasis and were found to be safe with acceptable tolerability. Tazarotene cream 0.1% was generally more effective, although slightly less well tolerated, than the 0.05% cream.

Original languageEnglish (US)
Pages (from-to)760-767
Number of pages8
JournalJournal of the American Academy of Dermatology
Volume48
Issue number5
DOIs
StatePublished - May 1 2003
Externally publishedYes

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Psoriasis
Safety
Therapeutics
Therapeutic Uses
Signs and Symptoms
Gels
tazarotene
Clinical Trials
Skin

ASJC Scopus subject areas

  • Dermatology

Cite this

Tazarotene cream in the treatment of psoriasis : Two multicenter, double-blind, randomized, vehicle-controlled studies of the safety and efficacy of tazarotene creams 0.05% and 0.1% applied once daily for 12 weeks. / Weinstein, Gerald D.; Koo, John Y M; Krueger, Gerald G.; Lebwohl, Mark G.; Lowe, Nicholas J.; Menter, M. Alan; Lew-Kaya, Deborah A.; Sefton, John; Gibson, John R.; Walker, Patricia S.; Ast, Ernest; Bagel, Jerry; Breneman, Debra L.; Bright, Ross D.; Davis, Steven A.; Duvic, Madeleine; Eisen, Drore; Feldman, Steven R.; Fiedler, Virginia C.; Fitzpatrick, Richard; Fivenson, David P.; Goffe, Bernard S.; Hanifin, Jon; Hong, Steven R.; Jones, Terry M.; Kempers, Steven E.; Kraus, Stephen J.; Krusinski, Paul A.; Leyden, James J.; Maloney, J. Michael; Miller, Bruce H.; Pariser, David M.; Phillips, Tania J.; Reyes, Blas; Reynolds, Owen; Rist, Toivo E.; Russo, Glenn G.; Shavin, Joel S.; Stewart, Daniel; Swinyer, Leonard J.; Tschen, Eduardo H.; Wolf, David I.

In: Journal of the American Academy of Dermatology, Vol. 48, No. 5, 01.05.2003, p. 760-767.

Research output: Contribution to journalArticle

Weinstein, GD, Koo, JYM, Krueger, GG, Lebwohl, MG, Lowe, NJ, Menter, MA, Lew-Kaya, DA, Sefton, J, Gibson, JR, Walker, PS, Ast, E, Bagel, J, Breneman, DL, Bright, RD, Davis, SA, Duvic, M, Eisen, D, Feldman, SR, Fiedler, VC, Fitzpatrick, R, Fivenson, DP, Goffe, BS, Hanifin, J, Hong, SR, Jones, TM, Kempers, SE, Kraus, SJ, Krusinski, PA, Leyden, JJ, Maloney, JM, Miller, BH, Pariser, DM, Phillips, TJ, Reyes, B, Reynolds, O, Rist, TE, Russo, GG, Shavin, JS, Stewart, D, Swinyer, LJ, Tschen, EH & Wolf, DI 2003, 'Tazarotene cream in the treatment of psoriasis: Two multicenter, double-blind, randomized, vehicle-controlled studies of the safety and efficacy of tazarotene creams 0.05% and 0.1% applied once daily for 12 weeks', Journal of the American Academy of Dermatology, vol. 48, no. 5, pp. 760-767. https://doi.org/10.1067/mjd.2003.103
Weinstein, Gerald D. ; Koo, John Y M ; Krueger, Gerald G. ; Lebwohl, Mark G. ; Lowe, Nicholas J. ; Menter, M. Alan ; Lew-Kaya, Deborah A. ; Sefton, John ; Gibson, John R. ; Walker, Patricia S. ; Ast, Ernest ; Bagel, Jerry ; Breneman, Debra L. ; Bright, Ross D. ; Davis, Steven A. ; Duvic, Madeleine ; Eisen, Drore ; Feldman, Steven R. ; Fiedler, Virginia C. ; Fitzpatrick, Richard ; Fivenson, David P. ; Goffe, Bernard S. ; Hanifin, Jon ; Hong, Steven R. ; Jones, Terry M. ; Kempers, Steven E. ; Kraus, Stephen J. ; Krusinski, Paul A. ; Leyden, James J. ; Maloney, J. Michael ; Miller, Bruce H. ; Pariser, David M. ; Phillips, Tania J. ; Reyes, Blas ; Reynolds, Owen ; Rist, Toivo E. ; Russo, Glenn G. ; Shavin, Joel S. ; Stewart, Daniel ; Swinyer, Leonard J. ; Tschen, Eduardo H. ; Wolf, David I. / Tazarotene cream in the treatment of psoriasis : Two multicenter, double-blind, randomized, vehicle-controlled studies of the safety and efficacy of tazarotene creams 0.05% and 0.1% applied once daily for 12 weeks. In: Journal of the American Academy of Dermatology. 2003 ; Vol. 48, No. 5. pp. 760-767.
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abstract = "Background: Tazarotene in a gel formulation is widely used in the treatment of psoriasis. Objective: To determine the efficacy and safety of tazarotene 0.1{\%} and 0.05{\%} creams in the treatment of psoriasis. Methods: A total of 1303 patients participated in 2 clinical trials. Patients applied tazarotene creams 0.1{\%} and 0.05{\%} or vehicle once daily to all psoriatic lesions for 12 weeks followed by a 12-week posttreatment period. Results: Both creams were significantly more effective than vehicle on the basis of an overall assessment of psoriasis, a global response to treatment, and reduction in plaque elevation and scaling. Therapeutic effect was maintained during the posttreatment period. Common adverse events included signs and symptoms of skin irritation. Conclusion: Tazarotene creams were associated with significant reductions in the severity of the clinical signs of psoriasis and were found to be safe with acceptable tolerability. Tazarotene cream 0.1{\%} was generally more effective, although slightly less well tolerated, than the 0.05{\%} cream.",
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T2 - Two multicenter, double-blind, randomized, vehicle-controlled studies of the safety and efficacy of tazarotene creams 0.05% and 0.1% applied once daily for 12 weeks

AU - Weinstein, Gerald D.

AU - Koo, John Y M

AU - Krueger, Gerald G.

AU - Lebwohl, Mark G.

AU - Lowe, Nicholas J.

AU - Menter, M. Alan

AU - Lew-Kaya, Deborah A.

AU - Sefton, John

AU - Gibson, John R.

AU - Walker, Patricia S.

AU - Ast, Ernest

AU - Bagel, Jerry

AU - Breneman, Debra L.

AU - Bright, Ross D.

AU - Davis, Steven A.

AU - Duvic, Madeleine

AU - Eisen, Drore

AU - Feldman, Steven R.

AU - Fiedler, Virginia C.

AU - Fitzpatrick, Richard

AU - Fivenson, David P.

AU - Goffe, Bernard S.

AU - Hanifin, Jon

AU - Hong, Steven R.

AU - Jones, Terry M.

AU - Kempers, Steven E.

AU - Kraus, Stephen J.

AU - Krusinski, Paul A.

AU - Leyden, James J.

AU - Maloney, J. Michael

AU - Miller, Bruce H.

AU - Pariser, David M.

AU - Phillips, Tania J.

AU - Reyes, Blas

AU - Reynolds, Owen

AU - Rist, Toivo E.

AU - Russo, Glenn G.

AU - Shavin, Joel S.

AU - Stewart, Daniel

AU - Swinyer, Leonard J.

AU - Tschen, Eduardo H.

AU - Wolf, David I.

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N2 - Background: Tazarotene in a gel formulation is widely used in the treatment of psoriasis. Objective: To determine the efficacy and safety of tazarotene 0.1% and 0.05% creams in the treatment of psoriasis. Methods: A total of 1303 patients participated in 2 clinical trials. Patients applied tazarotene creams 0.1% and 0.05% or vehicle once daily to all psoriatic lesions for 12 weeks followed by a 12-week posttreatment period. Results: Both creams were significantly more effective than vehicle on the basis of an overall assessment of psoriasis, a global response to treatment, and reduction in plaque elevation and scaling. Therapeutic effect was maintained during the posttreatment period. Common adverse events included signs and symptoms of skin irritation. Conclusion: Tazarotene creams were associated with significant reductions in the severity of the clinical signs of psoriasis and were found to be safe with acceptable tolerability. Tazarotene cream 0.1% was generally more effective, although slightly less well tolerated, than the 0.05% cream.

AB - Background: Tazarotene in a gel formulation is widely used in the treatment of psoriasis. Objective: To determine the efficacy and safety of tazarotene 0.1% and 0.05% creams in the treatment of psoriasis. Methods: A total of 1303 patients participated in 2 clinical trials. Patients applied tazarotene creams 0.1% and 0.05% or vehicle once daily to all psoriatic lesions for 12 weeks followed by a 12-week posttreatment period. Results: Both creams were significantly more effective than vehicle on the basis of an overall assessment of psoriasis, a global response to treatment, and reduction in plaque elevation and scaling. Therapeutic effect was maintained during the posttreatment period. Common adverse events included signs and symptoms of skin irritation. Conclusion: Tazarotene creams were associated with significant reductions in the severity of the clinical signs of psoriasis and were found to be safe with acceptable tolerability. Tazarotene cream 0.1% was generally more effective, although slightly less well tolerated, than the 0.05% cream.

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