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

Autor: H R Jerajani, A S Kumar, Maria Kuruvila, H V Nataraja, Mariam Philip, D V S Pratap, T K Sumathy, Binny Krishnankutty, Shilpi Dhawan, Dennis Thomas
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Zdroj: Indian Journal of Dermatology, Vol 56, Iss 6, Pp 652-656 (2011)
Druh dokumentu: article
ISSN: 0019-5154
1998-3611
DOI: 10.4103/0019-5154.91822
Popis: 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
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