Clinical trial · Interventional
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
NCT01745159CI-TRIAL-00015317completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate/Severe Atopic Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- continued tacrolimus treatment
- description
- children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.
- interventionNames
- Drug: tacrolimus
- type
- NO_INTERVENTION
- label
- no additional treatment
- description
- children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.
Primary outcomes (1)
- measure
- Time to first DE (disease exacerbation)
- timeFrame
- 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as AD according to Williams diagnostic criteria. 2. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland 3. At least approximately 10 % of body area 4. Patient is able to reach the centre within 3 days in case of a disease exacerbation. 5. Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
References
Publications (0)
Data not yet available
No reference posted for this study.