Impacts of exposure to topical calcineurin inhibitors on metabolism in vitiligo infants.
Pediatr Res
; 93(3): 661-665, 2023 02.
Article
en En
| MEDLINE
| ID: mdl-35681095
ABSTRACT
BACKGROUND:
Tacrolimus ointment is a recently developed topical immunomodulator that has been approved for use in patients with vitiligo older than 2 years. Concern regarding potential systemic toxic effects has limited treatment options for children younger than 2 years. We wanted to determine whether topical tacrolimus therapy is safe and effective in patients with vitiligo younger than 2 years.METHODS:
The present 6-month clinical trial was conducted to evaluate the efficacy and safety of 0.03% tacrolimus in the treatment of vitiligo in children under 2 years of age. Meanwhile, serum and urine samples were collected, and liquid chromatography-mass spectrometry was performed to generate the serum and urine metabolic profile data of patients and healthy controls.RESULTS:
The overall response rate at the sixth month, which was defined by the degree of re-pigmentation, was 100%. As revealed by blood monitoring and metabolite detection 6 months later, there was no difference between the treatment group and the control group. There is no evidence that long-term topical application of 0.03% tacrolimus ointment will cause metabolite or other physical changes in the body.CONCLUSIONS:
Tacrolimus ointment appears to be effective and safe in the treatment of vitiligo in children younger than 2 year. TRIAL REGISTRATION http//www.chictr.org.cn identifier ChiCTR 2100045920. IMPACT We first reported the efficacy and safety of topical application of 0.03% tacrolimus ointment in infants with vitiligo characterized by the metabolites. There is no evidence that long-term topical application of 0.03% tacrolimus ointment will cause metabolite or other physical changes in the body. This study provide evidence for the TCI treatment of infants with vitiligo.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Vitíligo
/
Inhibidores de la Calcineurina
Tipo de estudio:
Clinical_trials
Límite:
Child
/
Humans
/
Infant
Idioma:
En
Revista:
Pediatr Res
Año:
2023
Tipo del documento:
Article
País de afiliación:
China