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Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier:
NCT00914186
First received: May 28, 2009
Last updated: November 30, 2011
Last verified: November 2011
Results First Received: February 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: TS022
Drug: 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
Recruitment period for the study started 03Jun09. It was the responsibility of the PI for advertisement and recruitment of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a seven day run-in-period in which subjects self-applied the Vehicle control twice daily.

Reporting Groups
  Description
Vehicle once daily
TS-022 0.005% lotion/once daily
TS-022 0.010% lotion/once daily
TS-022 0.020% lotion/once daily

Participant Flow:   Overall Study
    Vehicle     TS-022 0.005%     TS-022 0.010%     TS-022 0.020%  
STARTED     31     30     31     30  
COMPLETED     28     28     29     20  
NOT COMPLETED     3     2     2     10  



  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
Vehicle once daily
TS-022 0.005% lotion/once daily
TS-022 0.010% lotion/once daily
TS-022 0.020% lotion/once daily
Total Total of all reporting groups

Baseline Measures
    Vehicle     TS-022 0.005%     TS-022 0.010%     TS-022 0.020%     Total  
Number of Participants  
[units: participants]
  31     30     31     30     122  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     31     30     31     30     122  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.5  ± 13.53     38.0  ± 11.63     35.1  ± 13.78     39.0  ± 13.89     36.4  ± 13.23  
Gender  
[units: participants]
         
Female     19     21     17     20     77  
Male     12     9     14     10     45  
Region of Enrollment  
[units: participants]
         
United States     31     30     31     30     122  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Pruritis Visual Analog Scale (VAS)   [ Time Frame: Baseline through Study Day 36 (Visit 7) ]

2.  Primary:   Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events   [ Time Frame: Baseline through Study Day 36 (Visit 7) ]

3.  Primary:   Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas   [ Time Frame: baseline through Study Day 36 (Visit 7) ]

4.  Primary:   Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score   [ Time Frame: Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7) ]

5.  Primary:   Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas   [ Time Frame: baseline through Study Day 36 (Visit 7) ]

6.  Primary:   Skindex-29 Questionnaire to Measure the Subject’s Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.   [ Time Frame: Study Day -7 through Study Day 22 ]

7.  Primary:   Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale   [ Time Frame: Baseline through Study Day 36 (Visit 7) ]


  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
Slower than expected enrollment and a higher than expected screen failure rate.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Fred Henry MS, MPH,
Organization: Taisho Pharmaceutical R&D Inc.
phone: 973-898-6200
e-mail: F-Henry@taihso-rd.com


No publications provided


Responsible Party: Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier: NCT00914186     History of Changes
Other Study ID Numbers: TS022-US201
Study First Received: May 28, 2009
Results First Received: February 28, 2011
Last Updated: November 30, 2011
Health Authority: United States: Food and Drug Administration