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Efficacy and Safety Study of CD2027 Ointment 3 Mcg/g Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00919763
First received: June 9, 2009
Last updated: May 29, 2012
Last verified: May 2012
Results First Received: January 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: CD 2027
Drug: CD 2027 Vehicle

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CD2027 Ointment 3 Mcg/g, Twice Daily Topical Ointment
CD 2027 Vehicle, Twice Daily Topical Ointment

Participant Flow:   Overall Study
    CD2027 Ointment 3 Mcg/g, Twice Daily     CD 2027 Vehicle, Twice Daily  
STARTED     53     49  
COMPLETED     41     45  
NOT COMPLETED     12     4  



  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.
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Reporting Groups
  Description
CD2027 Ointment 3 Mcg/g, Twice Daily Topical Ointment
CD 2027 Vehicle, Twice Daily Topical Ointment
Total Total of all reporting groups

Baseline Measures
    CD2027 Ointment 3 Mcg/g, Twice Daily     CD 2027 Vehicle, Twice Daily     Total  
Number of Participants  
[units: participants]
  53     49     102  
Age  
[units: participants]
     
<=18 years     0     2     2  
Between 18 and 65 years     50     46     96  
>=65 years     3     1     4  
Age  
[units: years]
Mean ± Standard Deviation
  38.3  ± 14.9     40.3  ± 13.8     39.3  ± 14.3  
Gender  
[units: participants]
     
Female     28     20     48  
Male     25     29     54  
Region of Enrollment  
[units: participants]
     
United States     53     49     102  



  Outcome Measures

1.  Primary:   Total Sum Score (TSS)of Target Lesion   [ Time Frame: at Week 4 ]

2.  Secondary:   Percent Change in TSS   [ Time Frame: from Baseline to Week 4 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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: Michael Graeber, MD, Head of Global Clinical Project Management and US Development
Organization: Galderma
phone: 609-860-8201
e-mail: michael.graeber@galderma.com


No publications provided


Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00919763     History of Changes
Other Study ID Numbers: RD.06.SPR.18158
Study First Received: June 9, 2009
Results First Received: January 19, 2012
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration