A 4-week, randomized, multicenter, parallel-group, placebo-controlled study to investigate the effect of Elidel (pimecrolimus) cream 1% on the Quality of Life (QoL) of patients with moderate facial Atopic Eczema (AE), in whom previous treatment, including appropriate use of topical corticosteroids (TCS), has been unsatisfactory.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002688-25-GB

Enrollment

Registered

2005-06-27

Start date

2005-01-07

Completion date

Unknown

Last updated

2015-02-02

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

Conditions

Atopic Eczema (AE)

Interventions

Trade Name: Elidel 1% Cream Product Name: Pimecrolimus Product Code: SDZASM981 Pharmaceutical Form: Cream INN or Proposed INN: pimecrolimus CAS Number: 137071-32-0 Current Sponsor code: ASM981 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males and females aged 18 years and over Active moderate facial AE at baseline Diagnosis of AE fulfilling diagnostic criteria of Williams Pruritus score of 2 or above at baseline Patients in whom further use of topical corticosteroids is clinically inappropriate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Females of childbearing potenial Patients who have received phototherapy or systemic therapy known or suspected to have an effect on AE within 1 month of visit 1

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that Elidel used on the face (b.i.d.) for 4 weeks in patients with moderate facial AE produces a superior quality of life from baseline compared to vehicle.;Secondary Objective: To determine the effect of Elidel in patients with moderate facial AE on patient satisfaction, reduction in facial itch and time to clearance of AE after 4 weeks. In addition, drug utilization, safety and tolerability will be assessed at the end of 4 weeks.;Primary end point(s): Change from baseline in QoLIAD (Quality of Life Index - Atopic Dermatitis) score at 4 weeks.	—

Measure

Time frame

Main Objective: To test the hypothesis that Elidel used on the face (b.i.d.) for 4 weeks in patients with moderate facial AE produces a superior quality of life from baseline compared to vehicle.;Secondary Objective: To determine the effect of Elidel in patients with moderate facial AE on patient satisfaction, reduction in facial itch and time to clearance of AE after 4 weeks. In addition, drug utilization, safety and tolerability will be assessed at the end of 4 weeks.;Primary end point(s): Change from baseline in QoLIAD (Quality of Life Index - Atopic Dermatitis) score at 4 weeks.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026