Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis

NCT00801957 ↗

Phase 2 Completed 260 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.

Timeline

Start: 2003-03
Primary completion: 2004-11
Completion: 2004-11

Publications

Background Hofman T, Cranswick N, Kuna P, Boznanski A, Latos T, Gold M, Murrell DF, Gebauer K, Behre U, Machura E, Olafsson J, Szalai Z; International Tacrolimus Ointment Study Group. Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. Arch Dis Child. 2006 Nov;91(11):905-10. doi: 10.1136/adc.2006.094276. Epub 2006 Jun 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Hydrocortisone	Other / unclassified	1 %	Topical
Comparator	Hydrocortisone Butyrate	Unknown	0.1 %	Topical
Subject	Tacrolimus	Small molecule	0.03 %	Topical
Background	AC VAX	Vaccine	—	Intramuscular
Background	Meningitec	Vaccine	—	Intramuscular

Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis

Summary

Timeline

Publications

Drugs

Indications