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5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis

A 5-year, multicenter, open, randomized, parallel group study to demonstrate the short-term and long-term safety of Elidel (pimecrolimus, ASM981) 1% cream in the treatment of mild to moderate atopic dermatitis in young children (3- <12 months of age).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-008-04
Enrollment
67
Registered
2004-04-19
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

Cream of Pimecrolimus 1% Type of group
Pimecrolimus cream 1% will be applied in the areas of atopic dermatitis. Group name:Topical corticosteroids Type of group
Topical corticosteroids will be applied in areas of atopic dermatitis.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Aged 3 to < 12 months Diagnosis of AD fulfilling the diagnostic criteria of Seymour AD affecting at least 5% total body surface area Investigator´s Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline Informed consent

Exclusion criteria

Exclusion criteria: Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks Topical tacrolimus or pimecrolimus within 2 weeks Topical therapy (e.g., tar, topical corticosteroids) within 3 days Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids Clinical conditions other than AD that according to investigator can interfere with the evaluation

Design outcomes

Primary

MeasureTime frame
Outcome name:crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period Measure:Safety Assessed by Adverse Events Timepoints:throughout the 5-year study—

Secondary

MeasureTime frame
Outcome name:TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100. Measure:Body Surface Area Involved With Atopic Dermatitis Timepoints:throughout the 5-year study—

Countries

Germany, Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)