Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

Novartis

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Pimecrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00351052

CASM981CDE10

Details and patient eligibility

About

This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis

Enrollment: 184 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
• responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase

Exclusion criteria

• Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

184 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Pimecrolimus

Treatment:

Drug: Pimecrolimus

2

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Placebo