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 |
| Summary: | 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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| ISSN: | 2249-782X 0973-709X |