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NATURALIST, OPEN, MULTICENTER, LONG-TERM MANAGEMENT STUDY, IN PATIENTS GREATER THAN OR EQUAL THAN 3 MONTHS AGE WITH MILD OR MODERATE ATOPIC DERMATITIS, USING ELIDEL (PIMECROLIMUS) CREAM 1%

NATURALIST, OPEN, MULTICENTER, LONG-TERM MANAGEMENT STUDY, IN PATIENTS GREATER THAN OR EQUAL THAN 3 MONTHS AGE WITH MILD OR MODERATE ATOPIC DERMATITIS, USING ELIDEL (PIMECROLIMUS) CREAM 1%

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-075-02
Enrollment
50
Registered
2002-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

ASM981 Type of group
The ASM 981 will be provided to patients in 50 or 100 g tubes, and will be used b.i.d. according to need, while the signs and symptoms of AD are present.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men or women Age> 3 months The subjects must have a clear diagnosis of atopic dermatitis. History of mild to moderate atopic dermatitis.

Exclusion criteria

Exclusion criteria: That they are pregnant or breastfeeding. That they have pregnancy potential and are not using a reliable and medically accepted method of contraception, during the study and until at least 4 weeks after the end of the treatment phase.

Design outcomes

Primary

MeasureTime frame
Outcome name:Quality of Life Index Measure:Parents Quality of Life Index - Atopic Dermatitis Timepoints:12 month

Secondary

MeasureTime frame
Outcome name:They will consist of the monitoring and the registration of all the EAs and of all the EASs following the same guidelines of the original protocol. Measure:Security assessments Timepoints:12 month

Countries

Arabia Saudi, Austria, Botswana, Brazil, Colombia, Czech Republic, Finland, Germany, Guatemala, Iceland, Israel, Kuwait, Latovia, Mexico, New Zealand, Peru, Portugal, Spain, United Kindgdom, United States, Venezuela

Outcome results

None listed

Source: REPEC (via WHO ICTRP)