The Phase III Open Label Study of CLDM-T Gel in the Treatment of Acne Vulgaris.
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Accession number;99A0451288
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| Title;The Phase III Open Label Study of CLDM-T Gel in the Treatment of Acne Vulgaris. |
| Author;
Cldmtkenkyukai
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.15;NO.4;PAGE.629-643(1999)
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| Figure&Table&Reference;FIG.5, TBL.17, REF.16 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Efficacy and safety of clindamycin phosphate topical gel(CLDM-T) was investigated in the treatment of acne vulgaris patients with multiple inflamed eruptions when it was topically administered for the period longer than 4 weeks. The results thereof are described below. 1) A total of 36 patients were enrolled in the study. Of these patients, the number of patients evaluable for statistical analysis of efficacy, safety and usefulness was 31, 32 and 31, respectively. 2) Number of inflamed eruptions significantly decreased from baseline in the patients who were evaluable for efficacy analysis(repeated measurement ANOVA:p<0.001). Severity of inflammation at baseline was severe in 3 patients and moderate in 28 patients. At 12 weeks after start of the treatment, the inflammation was of mild or lesser degree in 19 patients. 3) As a result of efficacy rating, the patients who were rated effective or markedly effective accounted for 83.9%(26/31) patients). 4) As a result of overall safety rating, the patients who were rated safe accounted for 87.5%(28/32 patients). 5) As a result of usefulness rating, the patients who were rated useful or markedly useful accounted for 83.9%(26/31 patients). 6) 4 adverse reactions of itching were observed in 4 patients(12.5%), but all of them disappeared during the treatment or immediately after suspension of the treatment. 7) 1 case of abnormal change in the laboratory values occurred as urine protein(-.RAR..+-.) in 1 patient. According to the above results, CLDM-T was suggested to be sufficiently effective with no particular safety concern and also useful when it was topically administered in acne vulgaris with multiple inflamed eruptions for longer than 4 weeks. (author abst.) |
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