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.