Two randomized, double-blind, controlled trials of 2219 subjects to compare the combination clindamycin/tretinoin hydrogel with each agent alone and vehicle.

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Presentation transcript:

Two randomized, double-blind, controlled trials of 2219 subjects to compare the combination clindamycin/tretinoin hydrogel with each agent alone and vehicle for the treatment of acne vulgaris James J. Leyden, MD, Lincoln Krochmal, MD, Alex Yaroshinsky, PhD Journal of the American Academy of Dermatology Volume 54, Issue 1, Pages 73-81 (January 2006) DOI: 10.1016/j.jaad.2005.04.046 Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Schematic profile of randomized controlled study. Journal of the American Academy of Dermatology 2006 54, 73-81DOI: (10.1016/j.jaad.2005.04.046) Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Mean percent reduction (SE) in inflammatory lesion counts from baseline to week 12 (end of treatment; intent-to-treat population). Asterisk, P ≤ .0043 versus combination gel (parametric analysis of variance model with last observation carried forward). Journal of the American Academy of Dermatology 2006 54, 73-81DOI: (10.1016/j.jaad.2005.04.046) Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Mean percent reduction (SE) in noninflammatory lesion counts from baseline to week 12 (end of treatment; intent-to-treat population). Asterisk, P ≤ .0004 versus combination gel (parametric analysis of variance model with last observation carried forward). Journal of the American Academy of Dermatology 2006 54, 73-81DOI: (10.1016/j.jaad.2005.04.046) Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Mean percent reduction (SE) in total lesion counts from baseline to week 12 (end of treatment; intent-to-treat population). Asterisk, P ≤ .0001 versus combination gel (parametric analysis of variance model with last observation carried forward). Journal of the American Academy of Dermatology 2006 54, 73-81DOI: (10.1016/j.jaad.2005.04.046) Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Kaplan-Meier curve of the time to 50% reduction in subject's total lesion counts. Journal of the American Academy of Dermatology 2006 54, 73-81DOI: (10.1016/j.jaad.2005.04.046) Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions

Fig 6 Investigator's Static Global Assessment (ISGA): Percentage of subjects with clear or almost clear skin (success) at week 12 (end of treatment; intent-to-treat population). Asterisk, P ≤ .0001 versus combination gel (Cochran-Mantel-Haenszel test [α = .05] stratified by site with last observation carried forward). Journal of the American Academy of Dermatology 2006 54, 73-81DOI: (10.1016/j.jaad.2005.04.046) Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions

Fig 7 Images of typical patient at baseline (A) and after treatment with combination hydrogel at week 12 (B). Journal of the American Academy of Dermatology 2006 54, 73-81DOI: (10.1016/j.jaad.2005.04.046) Copyright © 2005 American Academy of Dermatology, Inc. Terms and Conditions