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

Abstract

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.

Halometasone monohydrate (0.05%) in occupational contact dermatitis

“…reported treatment success rate of halometasone treatment as 91% which is close to our study results. [ 12 ] Yawalkar et al . obtained satisfactory results with halometasone in 717 patients with noninfected acute eczematous dermatoses.…”

“…This difference in result may be contributed to the fact that in the study by Jerajani et al ., all types of eczematous dermatoses were included whereas we evaluated the drug only on OCD. [ 12 ] The POEM is a tool for assessing atopic eczema and monitoring aspects of the disease that are important to patients. The total score (maximum 28) accurately reflect eczema-related morbidity whereas analysis of individual variables can provide useful information on whether acute (weeping, bleeding) or chronic (itching, dryness) changes are predominant and can help target therapy accordingly.…”

“…Previous studies have also revealed its efficacy, safety, and tolerability in Indian population with eczema. [ 9 12 ] Halometasone was well-tolerated without any systemic effect, and there were no reports of skin atrophy, which is usually associated with the topical use of corticosterioids. [ 9 12 19 20 ] In the earlier studies, the inclusion criteria were broad including different types of eczematous dermatoses or contact dermatitis.…”

“…[ 9 10 11 ] It has been approved in many European countries, but it has been launched in Indian market recently, and few clinical trials have been conducted in India on its efficacy and safety in eczematous dermatoses till date. [ 12 ] Our literature search revealed that there is a paucity of data on OCD in Indian population, and there was no study on efficacy and safety of topical halometasone in OCD. Hence, we planned this study to assess the efficacy and safety of halometasone in OCD and to compare the efficacy of the drug in allergic and irritant OCD.…”

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

“…[10–12] Safety, efficacy, and tolerability of Halometasone in Indian patients with acute and chronic eczema have been documented. [13]…”