Blanco D, van Rossem K, et al.
Pediatric dermatology. Date of publication 2013 Nov 1;volume 30(6):717-24.
1. Pediatr Dermatol. 2013 Nov-Dec;30(6):717-24. doi: 10.1111/pde.12107. Epub 2013
May 16.
A prospective two-year assessment of miconazole resistance in Candida spp. With
repeated treatment with 0.25% miconazole nitrate ointment in neonates and
infants with moderate to severe diaper dermatitis complicated by cutaneous
candidiasis.
Blanco D(1), van Rossem K.
Author information:
(1)Institute of Dermatology, Santo Domingo, Dominican Republic.
A petrolatum and zinc oxide-based ointment containing 0.25% miconazole nitrate
is reported to be effective and well tolerated in the treatment of diaper
dermatitis complicated by cutaneous candidiasis (DDCC). This prospective,
multicenter, open-label, long-term, phase IV study investigated the potential
resistance of Candida spp. to repeated topical use of 0.25% miconazole nitrate
in infants age 15 months and younger with moderate to severe DDCC. For initial
and recurring episodes of DDCC over the 2-year study period, subjects were
treated with a 7-day course of 0.25% miconazole nitrate ointment (active
components: miconazole nitrate 0.25%, zinc oxide 15%, and white petrolatum
81.35%) with a 7-day follow-up. Clinical and mycologic evaluations were
conducted before treatment (day 0) and 7 days after treatment (day 14).
Potential resistance to miconazole was defined using an arbitrary breakpoint of
minimum inhibitory concentration of 2 μg/mL. There was no evidence of resistance
to miconazole in Candida spp. after single or repeated treatment courses of
0.25% miconazole nitrate ointment. For the initial episode of DDCC, 83 of 168
subjects (49.4%) achieved a clinical cure, 77 (45.8%) achieved a mycologic cure,
and 49 (29.2%) achieved an overall cure (clinical and mycologic). The overall
cure rate for recurrent episodes of DDCC was similar to or numerically greater
than rates observed for the initial episode. Treatment of DDCC with 0.25%
miconazole nitrate ointment was effective and generally well tolerated. No
evidence of the development of resistance to miconazole in Candida spp. was
observed.
© 2013Wiley Periodicals, Inc.
DOI: 10.1111/pde.12107
PMID: 23675632 [Indexed for MEDLINE]
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