Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

Astellas

Status and phase: Completed; Phase 4

Conditions: Moderate/Severe Atopic Dermatitis

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01745159

ACN-PRT-AD-12-1

Details and patient eligibility

About

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.

Full description

This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.

Enrollment: 125 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

continued tacrolimus treatment

Experimental group

Description:

children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.

Treatment:

Drug: tacrolimus

no additional treatment

No Intervention group

Description:

children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.