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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

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: April 26, 2016
Last verified: April 2016
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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: April 26, 2016
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