Drug Information for VUSIONTM (0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) OintmentRx only. FOR TOPICAL USE ONLY. NOT FOR OPTHALMIC, ORAL, OR INTRAVAGINAL USE. (Barrier Therapeutics, Inc.): CLINICAL STUDIES

Ads
  • Study 1 was a double-blind, multicenter study in which VUSION Ointment was compared to the combination treatment of zinc oxide and white petrolatum (zinc oxide/white petrolatum) and enrolled 330 infants and toddlers with diaper dermatitis, 236 of whom were included in the modified intent-to-treat (MITT) population. The MITT population was defined as all subjects with confirmed Candida spp. who were dispensed study medication. In addition to diaper dermatitis at baseline, subjects were required to have candidiasis documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.

    The primary endpoint in Study 1 was “Overall Cure”, requiring that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically eradicated. Primary efficacy was assessed 1 week following the end of treatment, at Day 14.

    Study 1 results are shown in Table 1.

    “Overall Cure” required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically eradicated.

    Primary efficacy was assessed at Day 14, 1 week post-treatment.

    Table 1: Study 1 – Number of Subjects Achieving an Overall Cure

    ab
    Overall Curea

    VUSION Ointment

    n=112

    Zinc Oxide/White Petrolatum

    n=124

    Day 7

    (End of Treatment)

    8 (7%)

    1 (0.8%)

    Day 14b

    26 (23%)

    12 (10%)

    Two additional studies provided supportive evidence of the clinical efficacy of VUSION Ointment for infants and toddlers with diaper dermatitis, some who cultured positive for C. albicans. However, in the two additional studies, the presence of candidal infection was not established in culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

  • Drug Information Provided by National Library of Medicine (NLM).
Ads