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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00120523
First received: July 11, 2005
Last updated: December 10, 2012
Last verified: December 2012
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: Pimecrolimus
Drug: Topical corticosteroids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient was enrolled into the study on 05 Apr 2004, last patient completed on 04 Oct 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
Topical Corticosteroids

Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.

Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.


Participant Flow for 2 periods

Period 1:   Treatment Period
    Pimecrolimus     Topical Corticosteroids  
STARTED     1205     1213  
COMPLETED     836     874  
NOT COMPLETED     369     339  

Period 2:   Follow-Up Period
    Pimecrolimus     Topical Corticosteroids  
STARTED     120 [1]   70 [1]
COMPLETED     90     46  
NOT COMPLETED     30     24  
[1] Patients discontinued due to lost to follow-up or who withdrew consent were not part of this period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
Topical Corticosteroids

Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.

Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Total Total of all reporting groups

Baseline Measures
    Pimecrolimus     Topical Corticosteroids     Total  
Number of Participants  
[units: participants]
  1205     1213     2418  
Age  
[units: participants]
     
<=18 years     1205     1213     2418  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: months]
Mean ± Standard Deviation
  7.1  ± 2.71     7.1  ± 2.66     7.1  ± 2.69  
Gender  
[units: participants]
     
Female     461     471     932  
Male     744     742     1486  
Region of Enrollment  
[units: participants]
     
United States     106     110     216  
Germany     130     131     261  
Argentina     40     40     80  
Belgium     20     16     36  
Canada     52     64     116  
Chile     25     22     47  
China     60     59     119  
Colombia     48     52     100  
Czech Republic     26     23     49  
Ecuador     15     13     28  
Spain     51     48     99  
United Kingdom     32     27     59  
Greece     19     16     35  
Guatemala     53     56     109  
Hong Kong     5     4     9  
Hungary     39     40     79  
Iceland     97     98     195  
Netherlands     51     55     106  
Peru     55     51     106  
Poland     37     36     73  
Portugal     5     5     10  
Russian Federation     54     53     107  
Singapore     12     13     25  
Sweden     29     29     58  
Turkey     26     28     54  
Taiwan     30     30     60  
Venezuela     39     39     78  
South Africa     49     55     104  



  Outcome Measures
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1.  Primary:   Safety Assessed by Adverse Events   [ Time Frame: throughout the 5-year study ]

2.  Primary:   Growth Velocity (Height)   [ Time Frame: throughout the 5-year study ]

3.  Primary:   Growth Velocity (Weight)   [ Time Frame: throughout the 5-year study ]

4.  Primary:   Potential Effect on the Developing Immune System   [ Time Frame: throughout the 5-year study ]

5.  Secondary:   Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate   [ Time Frame: throughout the 5-year study ]

6.  Secondary:   Body Surface Area Involved With Atopic Dermatitis   [ Time Frame: throughout the 5-year study ]

7.  Secondary:   Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)   [ Time Frame: throughout the 5-year study ]

8.  Secondary:   Vital Signs and Physical Examinations: Blood Pressure (BP)   [ Time Frame: throughout the 5-year study ]

9.  Secondary:   Vital Signs and Physical Examinations: Pulse   [ Time Frame: throughout the 5-year study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Research
Organization: MEDA Pharma GmbH & Co. KG
phone: +49 6172 888 ext 01
e-mail: clinical.research@medapharma.de


No publications provided


Responsible Party: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00120523     History of Changes
Other Study ID Numbers: CASM981C2306
Study First Received: July 11, 2005
Results First Received: November 9, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Netherlands: Medicines Evaluation Board (MEB)
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Portugal: National Pharmacy and Medicines Institute
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency