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Hydrogel Patch for the Treatment of Eczema

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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
Enrollment 23
Recruitment Details Eligible eczema patients from one U.S. clinical site were invited to participate
Pre-assignment Details Consent was initially obtained from 23 participants, but 3 participants withdrew consent
Arm/Group Title TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 23
Completed 20
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
45.6  (19.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
11
  47.8%
Male
12
  52.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Change in Disease Severity: Percent Change in Mean EASI Score
Hide Description Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.
Arm/Group Title Hydrogel Patch TAC 0.1% Patch + TAC
Hide Arm/Group Description:
Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
Overall Number of Participants Analyzed 20 20 20
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
20 20 20
Mean (Full Range)
Unit of Measure: percentage change
-47
(-100 to 17)
-56
(-100 to 0)
-61
(-100 to 17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hydrogel Patch
Comments Baseline and post-treatment comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAC 0.1%
Comments Baseline and post-treatment comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patch + TAC
Comments Baseline and post-treatment comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Number of Adverse Events Associated With Treatment
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.
Arm/Group Title Hydrogel Patch Alone, TAC 0.1%, TAC + Patch
Hide Arm/Group Description:

This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, the second treated with 0.1 % triamcinolone ointment without patch, and the third treated with occlusion of eczema patch without ointment.

occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Adverse events
0
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Hide Arm/Group Description 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.
All-Cause Mortality
TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Affected / at Risk (%)
Total   0/23 (0.00%) 
Due to loss of funding, enrollment was terminated prior to intended accrual of 30 participants.
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
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