Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial
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:...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JCDR Research and Publications Private Limited
2014-08-01
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| Series: | Journal of Clinical and Diagnostic Research |
| Subjects: | |
| Online Access: | https://jcdr.net/articles/PDF/4769/9111_CE(%20%20)_F(Sh)_PF1(SNAK)_PFA(P)_PF2(PAK).pdf |
| _version_ | 1811258280618491904 |
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| author | Bhavik Bhavsar Bimal Choksi Jayesh Sanmukhani Alka Dogra Rizwan Haq Sudhanshu Mehta Santanu Mukherjee V Subramanian Shafiq Sheikh Ravindra Mittal |
| author_facet | Bhavik Bhavsar Bimal Choksi Jayesh Sanmukhani Alka Dogra Rizwan Haq Sudhanshu Mehta Santanu Mukherjee V Subramanian Shafiq Sheikh Ravindra Mittal |
| author_sort | Bhavik Bhavsar |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T18:10:49Z |
| format | Article |
| id | doaj.art-19f82e9676a441788069a0197c1e4af5 |
| institution | Directory Open Access Journal |
| issn | 2249-782X 0973-709X |
| language | English |
| last_indexed | 2024-04-12T18:10:49Z |
| publishDate | 2014-08-01 |
| publisher | JCDR Research and Publications Private Limited |
| record_format | Article |
| series | Journal of Clinical and Diagnostic Research |
| spelling | doaj.art-19f82e9676a441788069a0197c1e4af52022-12-22T03:21:50ZengJCDR Research and Publications Private LimitedJournal of Clinical and Diagnostic Research2249-782X0973-709X2014-08-0188YC05YC0910.7860/JCDR/2014/9111.4769Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical TrialBhavik Bhavsar0Bimal Choksi1Jayesh Sanmukhani2Alka Dogra3Rizwan Haq4Sudhanshu Mehta5Santanu Mukherjee6V Subramanian7Shafiq Sheikh8Ravindra Mittal9Consultant Dermatologist, Lavanya Skin Clinic, Ahmedabad, India.Consultant Dermatologist, Dr. Choksi’s Clinic, Surat, India.Manager, Department of Regulatory Affairs, Cadila Healthcare Ltd. Ahmedabad, India.Consultant Dermatologist, Dr. Alka Dogra’s Clinic, Ludhiana, India.Consultant Dermatologist, Radiance Skin Clinic, Nagpur, India.Consultant Dermatologist, Mehta Clinic, Ratnagiri, India.Consultant Dermatologist, Seth Diagnostic Centre, Kolkata, India.Consultant Dermatologist, Aswini Hospital, Villupuram, India.NDDS, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, India.Senior Vice-President, Department of Regulatory Affairs, Cadila Healthcare Ltd. Ahmedabad, India.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.https://jcdr.net/articles/PDF/4769/9111_CE(%20%20)_F(Sh)_PF1(SNAK)_PFA(P)_PF2(PAK).pdfacne vulgarisclindamycinclinical trialnano emulsion |
| spellingShingle | Bhavik Bhavsar Bimal Choksi Jayesh Sanmukhani Alka Dogra Rizwan Haq Sudhanshu Mehta Santanu Mukherjee V Subramanian Shafiq Sheikh Ravindra Mittal Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial Journal of Clinical and Diagnostic Research acne vulgaris clindamycin clinical trial nano emulsion |
| title | Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial |
| title_full | Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial |
| title_fullStr | Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial |
| title_full_unstemmed | Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial |
| title_short | Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial |
| title_sort | clindamycin 1 nano emulsion gel formulation for the treatment of acne vulgaris results of a randomized active controlled multicentre phase iv clinical trial |
| topic | acne vulgaris clindamycin clinical trial nano emulsion |
| url | https://jcdr.net/articles/PDF/4769/9111_CE(%20%20)_F(Sh)_PF1(SNAK)_PFA(P)_PF2(PAK).pdf |
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