Comparative and non-comparative studies of the efficacy and tolerance of tioconazole cream 1% versus another imidazole and/or placebo in neonates and infants with candidal diaper rash and/or impetigo.
Eleven open multicentre studies were conducted to evaluate the efficacy of tioconazole cream 1% as a treatment for diaper rash with or without fungal (Candida) involvement, or impetigo in neonates and infants. In the dermal candidiasis/diaper rash group, 320 patients had either tioconazole (n = 220), a comparative imidazole (n = 43), or vehicle cream (n = 57) applied to the affected area twice daily. Twenty-one impetigo patients had only tioconazole cream 1% applied three times daily to lesions. The overall cure rate (patients with both clinical and mycological cure) at the end of treatment for tioconazole treated patients was 78%, for the comparative imidazole group it was 76% and for vehicle cream it was 39%. At the long-term follow-up evaluation approximately 6 weeks after treatment for patients with diaper rash, the overall cure rate was about the same in both tioconazole- and comparative imidazole-treated patients (87% and 90%, respectively), and 14% in patients using vehicle cream. Side-effects were coincident with disease symptoms and consisted primarily of erythema localized to the treatment area; they occurred in 5.4% (13/241) of the patients who received tioconazole and in 21% (9/43) of the patients who received comparative imidazole (econazole or miconazole). No side-effects were reported in this open study for the 57 patients who used vehicle cream. The results of these studies show that tioconazole cream 1% is safe and effective for the treatment of neonates and infants with dermal candidiasis, diaper rash and impetigo.
D000293:Adolescent; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002179:Candidiasis, Cutaneous / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003963:Diaper Rash / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D007169:Impetigo / Q000188:drug therapy*; D007223:Infant; D007231:Infant, Newborn; D008297:Male
D000935:Antifungal Agents; D007093:Imidazoles; C020527:tioconazole