Objective: The authors aimed to document the real-life performance of halometasone 0.05% w/w cream in day-today practice through this multicenter, open-label, Phase 4 study in India.
Methods: The authors enrolled 302 eligible patients either with acute or chronic eczema and treated them with halometasone 0.05% cream daily. Efficacy variables (i.e., investigator's global assessment and pruritis severity score) were assessed at baseline and end of study. Physician's global evaluation of efficacy was assessed at the end of treatment. Treatment response was assessed as either a success or failure based on improvement in investigator's global assessment.
Results: Study population included 61.26 percent male and 38.74 percent female participants, with the average age being 30.79±14.52 (mean±SD) years. Contact dermatitis was seen in 22.52 percent of the study population. The mean (±SD) duration of primary diagnosis was 461.45 days (±854.67). The most common type observed was "chronic" (60.49%), followed by "acute" (24.83%) conditions. Levocetirizine was the most commonly prescribed concomitant medication (31.39%), followed by emollients (15.33%). The mean and median duration of therapy was 18.50 and 25 days, respectively. Post therapy, there was a significant (p<0.0001) reduction in the severity of eczema and pruritus. Therapeutic success defined as cure (85.43%) and improvement (11.26%) was seen in 96.69 percent of patients. Physician's global evaluation of efficacy showed that in 96.67 percent of patients, treatment produced either an "excellent" (31.67%) or "good" (65.00%) response. Adverse events were reported in only 0.99 percent (3/302), with erythema being most common (0.66%).
Conclusion: Halometasone is efficacious with a good safety and tolerability profile in patients with noninfected corticosteroid-responsive eczematous dermatoses.