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Trial record 13 of 838 for:    eczema

Hydrogel Patch for the Treatment of Eczema

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.
ClinicalTrials.gov Identifier: NCT00924508
Recruitment Status : Terminated (Loss of Funding)
First Posted : June 19, 2009
Results First Posted : November 25, 2013
Last Update Posted : January 31, 2014
Sponsor:
Collaborator:
Teikoku Pharma USA, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Eczema
Interventions: Device: hydrogel patch
Drug: Triamcinolone (TAC) 0.1% cream

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible eczema patients from one U.S. clinical site were invited to participate

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Consent was initially obtained from 23 participants, but 3 participants withdrew consent

Reporting Groups
  Description
TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.

Participant Flow:   Overall Study
    TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
STARTED   23 
COMPLETED   20 
NOT COMPLETED   3 
Withdrawal by Subject                3 



  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
  Description
TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.

Baseline Measures
   TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.6  (19.2) 
Gender 
[Units: Participants]
 
Female   11 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures

1.  Primary:   Change in Disease Severity: Percent Change in Mean EASI Score   [ Time Frame: Baseline, 6 weeks ]

2.  Secondary:   Number of Adverse Events Associated With Treatment   [ Time Frame: 6 weeks ]


  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
Due to loss of funding, enrollment was terminated prior to intended accrual of 30 participants.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John Koo, MD
Organization: UCSF
phone: 415-476-6281
e-mail: john.koo@ucsfmedctr.org



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00924508     History of Changes
Other Study ID Numbers: Hydrogel for Eczema
First Submitted: June 17, 2009
First Posted: June 19, 2009
Results First Submitted: September 18, 2013
Results First Posted: November 25, 2013
Last Update Posted: January 31, 2014