Science Links Japan | The Clinical Phase II Study of CLDM-T Gel in the Treatment of Acne Vulgaris - Double-blind Comparative Study, Evaluation of Efficacy, Safety and Optimal Concentration of CLDM-T Gel in the Treatment of Acne Vulgaris.

The Clinical Phase II Study of CLDM-T Gel in the Treatment of Acne Vulgaris - Double-blind Comparative Study, Evaluation of Efficacy, Safety and Optimal Concentration of CLDM-T Gel in the Treatment of Acne Vulgaris.

Accession number;99A0451286

Title;The Clinical Phase II Study of CLDM-T Gel in the Treatment of Acne Vulgaris - Double-blind Comparative Study, Evaluation of Efficacy, Safety and Optimal Concentration of CLDM-T Gel in the Treatment of Acne Vulgaris.

Author; Cldmtkenkyukai

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.15;NO.4;PAGE.583-602(1999)

Figure&Table&Reference;FIG.4, TBL.16, REF.18

Pub. Country;Japan

Language;Japanese

Abstract;A randomized, double-blind comparative study was conducted to investigate the efficacy, safety and optimal concentration of clindamycin phosphate topical gel(CLDM-T) in the treatment of acne vulgaris. Patients were randomized to receive CLDM-T 2% gel, CLDM-T 1% gel or vehicle. The 3 treatment groups had decrease from baseline in counts of inflammatory eruptions, with the CLDM-T 2% and 1% groups significantly superior to the vehicle group. There was no statistically significant differences in reduction of inflammatory eruptions between the CLDM-T 2% and 1% groups. .CHI.2 test documented statistically significant difference in the efficacy rate of the CLDM-T 2%, 1% and vehicle at 81.6%, 80.9% and 53.8%, respectively. It was demonstrated by Wilcoxon rank-sum test that both CLDM-T 2% and 1% groups were significantly superior in efficacy than the vehicle group. The proportion of patients who were assessed safe(safety rate) was 85.9%, 95.2% and 87.7% in the CLDM-T 2%, 1% and vehicle groups, respectively. 10 adverse reactions were reported by 8 of 64(12.5%) patients treated with the CLDM-T 2%;1 adverse reaction was reported by 1 of 63(1.6%) patients treated with the CLDM-T 1%; and 11 adverse reactions were reported by 8 of 65(12.3%) patients given the vehicle. Most common adverse reactions were skin irritation and facial redness; and no serious adverse reaction was noted. There was no clinically significant change from baseline as a result of the clinical laboratory tests. The above results suggest that CLDM-T topical gel is superior in efficacy and comparable in safety to the vehicle in treating acne vulgaris. Also, it is estimated that CLDM-T 1% gel is the most optimal concentration for treatment of acne vulgaris. (author abst.)

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