A 16-week, randomized, multi-center, parallel-group, pimecrolimus-blinded, controlled study (4-week treatment period followed by 12-week observational period) to evaluate the safety of concomitant use of ASM 981 (pimecrolimus) cream 1% (BID) plus topical corticosteroid (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000839-17-IT

Enrollment

400

Registered

2005-06-20

Start date

2005-04-11

Completion date

Unknown

Last updated

2012-04-24

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

Conditions

Treatment of severe atopic dermatitis MedDRA version: 6.1 Level: PT Classification code 10012438

Interventions

Trade Name: ELIDEL*1% CREMA 30 G Pharmaceutical Form: Cream INN or Proposed INN: Pimecrolimus Concentration unit: g gram(s) Concentration type: equal Concentration number: 50-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Germany, Italy

Outcome results

None listed

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