Evaluation of Efficacy, Safety and Tolerability of a Combination of Clobetasol, Neomycin and Miconazole Versus Betamethasone, Clotrimazole and Neomycin Versus Betamethasone, Gentamycin and Miconazole in Subjects with Eczematous Disorders Associated with underlying Tinea or Yeast Infections.
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Date
2014-09
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Abstract
Lobate GM Neo, 15 mg is a triple drug
combination of a steroid clobetasol with anti-fungal
miconazole and antibacterial neomycin in treatment of
Eczematous disorders associated with underlying Tinea or
Yeast Infections. Aims and Objectives: The study was
designed to evaluate the efficacy, safety and tolerability of
a combinations of clobetasol, neomycin and miconazole
(Group A) versus betamethasone, clotrimazole, neomycin
(Group B) versus betamethasone, gentamicin, miconazole
(Group C) in subjects with any type of eczematous disorder
associated with underlying tinea or yeast infection.
Materials and Methods: This was an open label, parallel
group, randomized comparative study. The primary
endpoint analyzed was improvement in clinical score from
baseline at the end of day 7 and other primary endpoint like
hyperpigmentation were analyzed by the visual analogue
scale of 1 to 10 at the end of day 7. Results: Thirty-six
subjects were randomized to three groups. The clinical score
showed a significant reduction from baseline at the end of
day 7 in all the groups, i.e. 82.9%, 81.3% and 85.6% in
Group A, B and C respectively. However, the difference
between the groups were not statistically significant. Mean
hyper pigmentation score showed significant decrease of
82.9% in Group A, 81.6% in Group B and 92.2% in Group
C from baseline at the end of day 7. Conclusion: The triple
combination of antifungal, antibacterial and potent steroid
was found to be efficacious, safe and tolerable in reducing
signs and symptoms (scaling, inflammation, burning and
itching) of eczematous disorder associated with underlying
tinea/yeast infection.
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Keywords
eczema, tinea, clobetasol, neomycin, miconazole
Citation
Shroff Hasmukh Jayantilal. Evaluation of Efficacy, Safety and Tolerability of a Combination of Clobetasol, Neomycin and Miconazole Versus Betamethasone, Clotrimazole and Neomycin Versus Betamethasone, Gentamycin and Miconazole in Subjects with Eczematous Disorders Associated with underlying Tinea or Yeast Infections. Indian Medical Gazette. 2014 Sep ; 148 (9): 325-332.