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

Abstract

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.

Diagnosis and management of diaper dermatitis in infants with emphasis on skin microbiota in the diaper area

“…5,52 As candidal infection is quite common in more severe cases of diaper dermatitis, antifungal agents such as nystatin, clotrimazole, miconazole, ketoconazole, and sertaconazole can be applied to the diaper area with every diaper change. 57 In addi- The lesions usually begin with vesicle formation. Later, the vesicles rupture and eczematous lesions occur.…”

“…Other manifestations of congenital syphilis include symmetric desquamation of the palms and soles, anemia, hepatosplenomegaly, jaundice, and changes in the long bones. 57,58 Diaper psoriasis Rare.…”

Superficial Mycoses Associated with Diaper Dermatitis

“…Nystatin is still commonly used [1–3, 11, 19, 31, 33], but is less active than imidazole derivatives. Therefore, if the infection does not respond in 1–3 days of nystatin treatment, switching to azoles is recommended.…”

“…Therefore, if the infection does not respond in 1–3 days of nystatin treatment, switching to azoles is recommended. The most widely used azoles are clotrimazole [1, 3, 7 11, 19] miconazole [1, 3, 6, 11, 19, 33], ketoconazole [11, 19], and bifonazole [28]. They are normally applied twice a day for 7–10 days and generally have high cure rates, ranging from 50 to 68 %.…”

Prospective trial for the clinical efficacy of anogenital skin care with miconazole nitrate‐containing soap for diaper candidiasis

“…8 Substantial efficacies of miconazole have been stated for the treatment of superficial fungal infections, such as dermatomycosis, onychomycosis and vulvovaginal mycoses. [9][10][11] The drug is applicable topically to any of the mucocutaneous sites affected by fungal infections. Another advantage of miconazole includes non-specific antibacterial action in impetigo and ecthyma, suggesting the additional therapeutic benefit of this drug not only for fungal clearance, but also for disruption of bacterial-fungal biofilm formation.…”