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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00919763
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : May 1, 2012
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: CD 2027
Drug: CD 2027 Vehicle

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 53   49   102 
[Units: Participants]
<=18 years   0   2   2 
Between 18 and 65 years   50   46   96 
>=65 years   3   1   4 
[Units: Years]
Mean (Standard Deviation)
 38.3  (14.9)   40.3  (13.8)   39.3  (14.3) 
[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.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

Responsible Party: Galderma Identifier: NCT00919763     History of Changes
Other Study ID Numbers: RD.06.SPR.18158
First Submitted: June 9, 2009
First Posted: June 12, 2009
Results First Submitted: January 19, 2012
Results First Posted: May 1, 2012
Last Update Posted: June 4, 2012