A Phase 2 interventional study of tacrolimus ointment 0.03% and hydrocortisone acetate ointment 1% in Atopic Dermatitis, sponsored by Astellas Pharma Inc. Completed at 36 sites in 8 countries. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2014-09-18.
Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment
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.
At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 260 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tacrolimus ointment 0.03%
Drug: tacrolimus ointment 0.03% · Biological: Meningitec · Biological: AC VAX
hydrocortisone acetate 1% and butyrate 0.1%
Drug: hydrocortisone acetate ointment 1% · Drug: hydrocortisone butyrate ointment 0.1% · Biological: Meningitec · Biological: AC VAX
Control group vaccination and challenge dose only
Biological: Meningitec · Biological: AC VAX
topical application
Also known as: Protopic 0.03%
topical application
Also known as: ATC code H02AB09
topical application
Also known as: ATC code H02AB09
im injection
im injection
Percentage of patients with serum bactericidal antibody titer of ≥ 8
Time frame: 5 weeks
Assessment of other immunological parameters
Time frame: 7 months
The record gives a start of Mar 2003, a primary completion of Nov 2004 and a completion of Nov 2004. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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