The Clinical Trial of CLDM-T Gel in the Treatment of Acne Vulgaris-The Phase III Open Label Study.
|
Accession number;99A0451289
|
| Title;The Clinical Trial of CLDM-T Gel in the Treatment of Acne Vulgaris-The Phase III Open Label Study. |
| Author;
Cldmtkenkyukai
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.15;NO.4;PAGE.645-661(1999)
|
| Figure&Table&Reference;FIG.5, TBL.16, REF.16 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Efficacy and safety of clindamycin phosphate topical gel(CLDM-T) in the treatment of acne vulgaris was investigated in an open label study in which CLDM-T was topically administered for the period longer than 4 weeks. 1) A total of 28 patients were enrolled in the study. Of these patients, the number of patients evaluable for statistical analysis of efficacy, overall safety and usefulness was 16,23 and 19, respectively. 2) Number of inflamed eruptions was confirmed to significantly decrease from baseline(repeated measurement ANOVA:p<0.001). 3) The efficacy rate(percentage of the patients rated effective or markedly effective) was 75.0%(12/16 patients). 4) The overall safety rate(percentage of the patients rated safe) was 78.3%(18/23 patients). 5) The usefulness rate(percentage of the patients rated useful or markedly useful) was 63.2%(12/19 patients). 6) 4 adverse reactions reported by 3 patients(13.0%) consisted of the 2 cases of itching, 1 case of redness and 1 case of urticaria. 4 cases of abnormal change in laboratory values reported by 3 patients consisted of 2 cases of elevated total bilirubin, 1 case of elevated GPT and 1 case of urine sugar(-.RAR.+). The above results suggest that CLDM-T is effective and safe in the treatment of acne vulgaris over 4 weeks. (author abst.) |
|
|
|
Related Articles;
|
|
