Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial.

Bhavik Bhavsar,Bimal Choksi,Jayesh Sanmukhani, Alka Dogra,Rizwan Haq, Sudhanshu Mehta, Santanu Mukherjee, V Subramanian,Shafiq Sheikh,Ravindra Mittal

Journal of clinical and diagnostic research : JCDR(2014)

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摘要
BACKGROUND:Acne vulgaris of the face is a common dermatological disease with a significant impact on the quality of life, psychosocial development as well as self-esteem of the patients. Nano emulsion gel formulations are said to have various advantages over the conventional formulations. AIM:The present study was conducted to assess the comparative efficacy and safety of a nano-emulsion gel formulation of clindamycin with its conventional formulation in the treatment of acne vulgaris of the face. MATERIALS AND METHODS:This prospective, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by a nano emulsion gel formulation or conventional gel formulation of clindamycin (as phosphate) 1% locally applied twice daily for 12 weeks as per random allocation. Acne lesion counts (inflammatory, non-inflammatory and total) and severity grading were carried out on the monthly scheduled visits along with tolerability assessments. RESULTS:A total of 200 patients (97 males) were included for Intention to Treat analysis in the trial with 100 patients in each group. Reductions in total (69.3 vs. 51.9%; p<0.001), inflammatory (73.4 vs. 60.6%; p<0.005) and non inflammatory (65.1 vs. 43.7%; p<0.001) acne lesions were reported to be significantly greater with the nano-emulsion gel formulation as compared to the conventional gel formulation. Significantly more reduction in the mean acne severity score was noticeable with the nano-emulsion gel formulation (-1.6 ± 0.9 vs. -1.0 ± 0.8; p<0.001) than the comparator. A trend towards better safety profile of the nano emulsion gel formulation was reported. CONCLUSION:In the treatment of acne vulgaris of the face, clindamycin nano emulsion gel formulation appears to be more effective than the conventional gel formulation and is also well tolerated.
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