Phase III Clinical Study of Clindamycin Phosphate Topical Gel(CLDM-T) in the Treatment of Acne Vulgaris - Randomized Comparative Study with Nadifloxacin Cream as a Control Drug.

Accession number;99A0451287
Title;Phase III Clinical Study of Clindamycin Phosphate Topical Gel(CLDM-T) in the Treatment of Acne Vulgaris - Randomized Comparative Study with Nadifloxacin Cream as a Control Drug.
Author;Cldmtkenkyukai
Journal Title;Journal of Clinical Therapeutics & Medicines
Journal Code:Y0906A
ISSN:0910-8211
VOL.15;NO.4;PAGE.603-628(1999)
Figure&Table&Reference;FIG.6, TBL.16, REF.15
Pub. Country;Japan
Language;Japanese
Abstract;To make an objective assessment of efficacy, safety and usefulness of 1% CLDM-T in patients with acne vulgaris, a randomized comparative study was conducted with 1% nadifloxacin cream as a control drug under the system of patient registration by phone. 1) A total of 247 patients were enrolled in the study, and 126 patients were allocated to the 1% CLDM-T group(CLDM group) and 121 patients to the 1% nadifloxacin cream group(NDFX group). Of 247 cases, 7 cases of the CLDM group and 8 cases of the NDFX group were excluded from statistical analysis because of the protocol violations; therefore 119 cases of the CLDM group and 113 cases of the NDFX group, totaling to 232 cases, underwent the statistical analysis. 2) The efficacy rate was 73.1% in the CLDM group and 49.5% in the NDFX group, respectively. The analysis to show non-inferiority(.DELTA.=10%) showed that the 90% confidence interval for the difference in the efficacy rate between the two groups ranged from 12.7% to 34.5%, and that the efficacy in the CLDM group was non-inferior to in the NDFX group. The analysis revealed the statistically significant difference in efficacy between the two groups(p<0.001). 3) The global improvement rate at 4 weeks of the treatment was 75.6% in the CLDM group and 50.0% in the NDFX group, respectively. At every observation time point after 2 weeks of the treatment, significant differences were noted in global improvement rating between both groups(2 weeks:p<0.001, 3 weeks:p<0.001, 4 weeks:p<0.001). 4) The both groups decreased the number of inflamed eruptions with time. The CLDM group decreased the number from 21.6.+-.13.3(average.+-.standard deviation) before the treatment to 7.7.+-.8.2 after the treatment, and the NDFX group from 19.6.+-.10.8 before the treatment to 10.2.+-.7.6 after the treatment, with the CLDM group significantly superior to the NDFX group(drug effect:p<0.001, drug by time interaction:p<0.001).... (author abst.)