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. 2013 Mar;58(2):117-23.
doi: 10.4103/0019-5154.108041.

Evaluation of Efficacy, Safety, and Tolerability of Fixed Dose Combination (FDC) of Halometasone 0.05% and Fusidic Acid 2% W/W Topical Cream Versus FDC of Betamethasone Valerate 0.12% and Neomycin Sulphate 0.5% W/W Topical Cream in the Treatment of Infected Eczematous Dermatosis in Indian Subjects: A Randomized Open-Label Comparative Phase III Multi-Centric Trial

Dasiga Venkata Subrahmanya Pratap  1 , Mariam Philip, Narayana T Rao, Hemangi R Jerajani, Sainath A Kumar, Maria Kuruvila, Latha S Moodahadu, Shilpi Dhawan
Affiliations

Evaluation of Efficacy, Safety, and Tolerability of Fixed Dose Combination (FDC) of Halometasone 0.05% and Fusidic Acid 2% W/W Topical Cream Versus FDC of Betamethasone Valerate 0.12% and Neomycin Sulphate 0.5% W/W Topical Cream in the Treatment of Infected Eczematous Dermatosis in Indian Subjects: A Randomized Open-Label Comparative Phase III Multi-Centric Trial

Dasiga Venkata Subrahmanya Pratap et al. Indian J Dermatol. 2013 Mar.

Abstract

Aim: To evaluate the efficacy and safety of fixed drug combination (FDC) halometasone 0.05% and fusidic acid 2% (group A) vs FDC betamethasone 0.12% and neomycin sulfate 0.5% cream (group B) in acute or chronic infected eczematous dermatosis, through a randomized open-label, comparative, multicentric study.

Materials and methods: A total of 152 patients were randomized to either Group A or Group B. EASI (Eczema Area and Severity Index), IGA (Investigator's global assessment), scale for severity of eczema, pruritus, and safety parameters were assessed at baseline, Day 5/Day 10, Day 10/20, and Day 20/Day 30 for acute/chronic cases. Skin swabs were tested at screening, Day 10, and end of the study.

Results: Staphylococcus aureus was the frequently encountered causative agent. There was a significant reduction within the study groups in EASI, IGA scales for severity of eczema, pruritus at various visits, compared to baseline. At the end of study, 83.87% in group A and 65.71% in group B were culture negative. Cure rate was 54.28% and 50% in group A and B, respectively. Five adverse events were reported in five patients, of which three patients withdrew from the study.

Conclusion: Halometasone 0.05% and Fusidic acid 2% cream is effective, safe, well tolerated with comparable efficacy to the comparator in the treatment of acute and chronic infected eczematous dermatosis.

Keywords: Betamethasone 0.12% and neomycin sulfate 0.5% cream; eczema area and severity index; halometasone 0.05% and fusidic acid 2% cream; investigator's global assessment scale for severity of eczema; pruritus.

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Conflict of interest statement

Conflict of Interest: Dr. DVS Pratap, Dr. Mariam Philip, Dr. Narayana Rao T, Dr. Jerajani H R, Dr. A S Kumar and Dr. Kuruvila Maria, do not have any conflict of interest. Dr. M S Latha and Dr. Shilpi are the employees of Dr. Reddy's Laboratories Ltd., which is marketing halometasone+fusidic acid cream in India and are stakeholders having financial stakes in Dr. Reddy's Laboratories Ltd. by means of salary.

Figures

Figure 1
Figure 1
Study flow chart
Figure 2
Figure 2
Change in Mean pruritic severity score with treatment. There was no statistically significant difference in pruritus severity score at any of the visits between study drug and comparator
Figure 3
Figure 3
Treatment response at the end of therapy
Figure 4
Figure 4
Treatment response at the end of therapy (a) Pre treatment (b) Post treatment
Figure 5
Figure 5
Treatment response at the end of therapy (a) Pre treatment (b) Post treatment
See this image and copyright information in PMC

References

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