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Tacrolimus vs Hydrocortisone in Children with Atopic Dermatitis
NCT05324618Phase 4
Key facts
- Status
- Completed
- Start
- May 2022
- Primary completion
- Nov 2022
- Countries
- 1
- Sponsor
- Ain Shams University
- Modality
- Small Molecules
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 4, randomised, open-label trial of Tacrolimus Ointment 0.1% Iwaki in atopic dermatitis (AD) (2 arms), sponsored by Ain Shams University. Primary endpoints: Serum level of inflammatory cytokines at 4 months and Dermatitis severity scale at 4 months. Started May 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Tacrolimus group
0.03% topical tacrolimus ointment twice daily
Hydrocortisone group
1% hydrocortisone cream twice daily
03
Who it enrols
Children aged 2-16 years diagnosed with Atopic Dermatitis according to Hanifin and Rajka criteria, excluding those with other serious skin disorders or taking systemic corticosteroids/anti-inflammatory medications.
04
Endpoints
Primary
Serum level of inflammatory cytokines
Dermatitis severity scale
Secondary
Treatment related toxicities
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