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THERAPEUTIC ROUND
Year : 2011  |  Volume : 56  |  Issue : 6  |  Page : 652-656

Efficacy and safety of topical halometasone in eczematous dermatoses in Indian population: An open label, noncomparative study


1 Department of Dermatology, LTM Medical College and LTM General Hospital, Mumbai, India
2 Department of Dermatology, Owaisi Hospital and Research Centre, Hyderabad, India
3 Department of Dermatology and Venereology, KMC Hospital, Mangalore, India
4 Department of Dermatology, STD and Leprosy, Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore, India
5 Department of Dermatology, Venereology and Leprosy, Dr SMCSI Medical College, Karakonam, India
6 Department of Dermatology, Osmania Medical College and Hospital, Hyderabad, India
7 Department of Dermatology, MS Ramaiah Medical College, Bangalore, India
8 Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, India

Correspondence Address:
Binny Krishnankutty
TC 25/576, Housing Board Jn, Thampanoor, Trivandrum, Kerala
India
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Source of Support: This study was sponsored by Dr. Reddy’s Laboratories Ltd, Hyderabad, Conflict of Interest: None


DOI: 10.4103/0019-5154.91822

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Background: Topical steroids remain the mainstay of treatment in eczema, an inflammatory skin reaction characterized by pruritus, redness, scaling, and clustered oozing papulovesicles. Halometasone is a new potent corticosteroid approved in the Indian market for topical application in the treatment of dermatitis. Aims: To evaluate the efficacy and safety of halometasone in the treatment of acute or chronic noninfected eczematous dermatosis in Indian population. Materials and Methods: A prospective, open, multicentric, phase 3, noncomparative clinical trial conducted at outpatient departments of seven centres. Two hundred endogenous eczema patients meeting study criteria were enrolled. Halometasone 0.05% cream was applied twice daily for 30 days in chronic and 20 days in acute eczema patients. Calculation of eczema area and severity index, and assessment of investigator's global assessment of severity of eczema and severity of pruritus score were done at each visit and compared with baseline. All adverse events (AE) were captured and documented. Laboratory investigations including haematological tests, urinalysis, renal and liver function tests were performed at baseline and at end of treatment. Results: Of the 200 patients enrolled, 180 were chronic and 20 were acute eczema patients. It was found that there was a significant (P<0.001) improvement in all efficacy parameters compared with baseline. The treatment was shown to be successful in 91% patients. AE were reported in 30 patients and there was no serious AE reported. There was no clinically significant difference in laboratory investigations with treatment. Conclusions: Halometasone was shown to be safe and very effective in Indian patients with acute and chronic eczema and the drug was well tolerated.


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