Clobetasol propionate 0.05% lotion in the treatment of moderate to severe atopic dermatitis: a randomized evaluation versus clobetasol propionate emollient cream

Journal of Drugs in Dermatology, May-June, 2005 by Debra Breneman, Alan B. Fleischer, Jr., David Kaplan, Mark Lebwohl, Bruce Miller, David Pariser, Toivo Rist, L. Swinyer, Yin Liu, Valerie Foley

Table 1. Demographic Characteristics and Disease Information (ITT
population).

                                 Clobetasol          Clobetasol
                                 propionate lotion   propionate
                                 (N = 96)            emollient cream
                                                     (N = 100)

Age              Mean[  or -]SD   39.3[  or -]19.0    42.4[  or -]17.8
                 Range            12-84               12-83
Gender
  Male           n (%)            39 (40.6%)          45 (45.0%)
  Female         n (%)            57 (59.4%)          55 (55.0%)
Race
  White          n (%)            69 (71.9%)          67 (67.0%)
  Black          n (%)            12 (12.5%)          27 (27.0%)
  Yellow         n (%)             6 (6.3%)            1 (1.0%)
  Hispanic       n (%)             6 (6.3%)            4 (4.0%)
  Other          n (%)             3 (3.1%)            1 (1.0%)
Skin Phototype
  I              n (%)             4 (4.2%)            8 (8.0%)
  II             n (%)            28 (29.2%)          19 (19.0%)
  III            n (%)            33 (34.4%)          32 (32.0%)
  IV             n (%)            14 (14.6%)          14 (14.0%)
  V              n (%)             7 (7.3%)            6 (6.0%)
  VI             n (%)            10 (10.4%)          21 (21.0%)
Duration of      Mean[  or -]SD  219.5[  or -]183.3  215.5[  or -]188.5
Disease          Range            15.0-660.0           7.0-888.0
  (months)
Duration of      Mean[  or -]SD   60.7[  or -]105.0   80.3[  or -]138.8
Current Episode  Range             1.0-552.0           1.0-720.0
  (months)

                 Lotion
                 Vehicle             P-value*
                 (N = 33)

Age               40.7[  or -]19.4
                  12-86              0.34
Gender
  Male            15 (45.5%)         0.82
  Female          18 (54.5%)
Race
  White           23 (69.7%)
  Black            8 (24.2%)         0.08
  Yellow           0 (0%)
  Hispanic         2 (6.1%)
  Other            0 (0%)
Skin Phototype
  I                4 (12.1%)
  II               8 (24.2%)
  III              8 (24.2%)         0.35
  IV               4 (12.1%)
  V                4 (12.1%)
  VI               5 (15.2%)
Duration of      178.5[  or -]149.1
Disease            6.0-429.0         0.55
  (months)
Duration of
Current Episode   44.5[  or -]92.2   0.16
  (months)         1.0-456.0

* p-values for categorical variables (gender, race and skin photo type)
were based on Cochran-Mantel-Haenszel (CMH) test for General Association
adjusting for center. P-values for continuous variables were based on
2-way ANOVA model including treatment and center.

Acknowledgements: The authors would like to thank Toni Funicella, MD, Stephen Kraus, MD, Robert Loss, MD, Kenneth B. Gordon, MD, Eduardo Tschen, MD, and Marty E. Sawaya for their participation in this clinical trial and Patrick Goritz, Galderma R & D for his assistance in writing this publication.

Funding Research: This research was conducted for Galderma Medical Affairs, Inc as a part of the development program of clobetasol propionate 0.05% lotion.