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, Mariam Philip, Narayana T. Rao, Hemangi R. Jerajani, Sainath A. Kumar, Maria Kuruvila, Latha S. Moodahadu, Shilpi Dhawan

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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.

Original languageEnglish
Pages (from-to)117-123
Number of pages7
JournalIndian Journal of Dermatology
Volume58
Issue number2
DOIs
Publication statusPublished - 01-03-2013

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Betamethasone Valerate
Fusidic Acid
Neomycin
Eczema
Skin Diseases
Safety
Pruritus
Research Personnel
Drug Combinations
Therapeutics
Staphylococcus aureus
Skin
neomycin drug combination betamethasone
halometasone

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

@article{f156d45333ec49c5ab1835e662591bfa,
title = "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",
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.",
author = "Pratap, {Dasiga Venkata Subrahmanya} and Mariam Philip and Rao, {Narayana T.} and Jerajani, {Hemangi R.} and Kumar, {Sainath A.} and Maria Kuruvila and Moodahadu, {Latha S.} and Shilpi Dhawan",
year = "2013",
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doi = "10.4103/0019-5154.108041",
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TY - JOUR

T1 - 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

T2 - A randomized open-label comparative phase III multi-centric trial

AU - Pratap, Dasiga Venkata Subrahmanya

AU - Philip, Mariam

AU - Rao, Narayana T.

AU - Jerajani, Hemangi R.

AU - Kumar, Sainath A.

AU - Kuruvila, Maria

AU - Moodahadu, Latha S.

AU - Dhawan, Shilpi

PY - 2013/3/1

Y1 - 2013/3/1

N2 - 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.

AB - 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.

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JO - Indian Journal of Dermatology

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SN - 0019-5154

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