Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial
Published: August 1, 2014 | DOI: https://doi.org/10.7860/JCDR/2014/.4769
Bhavik Bhavsar, Bimal Choksi, Jayesh Sanmukhani, Alka Dogra, Rizwan Haq, Sudhanshu Mehta, Santanu Mukherjee, V Subramanian, Shafiq Sheikh, Ravindra Mitta
1. Consultant Dermatologist, Lavanya Skin Clinic, Ahmedabad, India.
2. Consultant Dermatologist, Dr. Choksi’s Clinic, Surat, India.
3. Manager, Department of Regulatory Affairs, Cadila Healthcare Ltd. Ahmedabad, India.
4. Consultant Dermatologist, Dr. Alka Dogra’s Clinic, Ludhiana, India.
5. Consultant Dermatologist, Radiance Skin Clinic, Nagpur, India.
6. Consultant Dermatologist, Mehta Clinic, Ratnagiri, India.
7. Consultant Dermatologist, Seth Diagnostic Centre, Kolkata, India.
8. Consultant Dermatologist, Aswini Hospital, Villupuram, India.
9. NDDS, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, India.
10. Senior Vice-President, Department of Regulatory Affairs, Cadila Healthcare Ltd. Ahmedabad, India.
Correspondence
Dr. Jayesh Sanmukhani,
Cadila Healthcare Ltd. Zydus Tower, Satellite Crossroad, Opposite ISKON Temple, Ahmedabad-380015, India.
Phone : 9904993188, E-mail : Jayesh_sanmukhani@yahoo.co.in
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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