The antifungal, sertaconazole (Ertaczo, Valeant, others), was no better than the topical vehicle placebo in a well controlled, multicenter trial to treat unremitting pruritus in atopic dermatitis (AD).
The antifungal drug sertaconazole (Ertaczo, Valeant, others) was no better than the topical vehicle placebo in a well-controlled, multicenter trial to treat unremitting pruritus in atopic dermatitis (AD).
Lead author Sonja Ständer, MD, Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany and colleagues reported that the product was safe, but not effective in relieving itch in adults with mild to moderate AD, in the September issue of Acta Dermato-Venereologica.
The investigators explained that the study was conducted because of the need for better treatments for itch in AD, and because of evidence of several intriguing mechanisms of sertaconazole. Preclinical studies, for example, have demonstrated that the agent reduces the release of cytokines from activated lymphocytes; mitigates inflammation in animal models of irritant contact dermatitis and neurogenic inflammation; inhibits contact hypersensitivity and scratching responses in a murine model of substance P-induced pruritus; and mediates anti-itch effects by increasing prostaglandin D2 levels in mast cells and macrophages.
"Therefore, sertaconazole with its positive safety profile and anti-inflammatory and anti-pruritic properties could be a possible solution to address pruritus in AD," Ständer and colleagues expressed.
The study was conducted at two treatment centers, with 70 subjects recruited to receive sertaconazole 2% cream or the topical vehicle placebo, applied twice daily to affected, itchy skin areas for a period of 4 weeks. 53 subjects were retained through the complete study period, with 24 receiving the active treatment. The intensity of pruritus was evaluated on a 5-point verbal rating scale, which was part of the patient's global assessment questionnaire. The target outcome of treatment efficacy was a 2 point or greater reduction in intensity of pruritus between baseline and week 4. Other outcome measures included the severity of AD and quality of life.
At study completion, most respondents on the Patient Benefit Index indicated, "Treatment helped not at all." The investigators summarized, "no significant difference in treating pruritus in subjects with mild to moderate AD could be revealed between the sertaconazole 2% cream and the vehicle cream."