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Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00828464
First received: January 22, 2009
Last updated: September 21, 2012
Last verified: September 2012
Results First Received: April 7, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hand Dermatosis
Intervention: Drug: clobetasol propionate

  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: First Subject Enrolled October 2008, Last Subject Enrolled January 2009.
  • Type of location: Dermatology Research Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
  1. Washout from use of systemic corticosteroid and/or other prohibited medications if used within 4 weeks of the baseline visit.
  2. Washout from use of topical corticosteroid therapy and/or other prohibited topical medications if used within 2 weeks prior to the baseline visit

Reporting Groups
  Description
Clobetasol Propionate Foam All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.

Participant Flow:   Overall Study
    Clobetasol Propionate Foam  
STARTED     30  
COMPLETED     29  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  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
Clobetasol Propionate Foam All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.

Baseline Measures
    Clobetasol Propionate Foam  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.5  ± 14.9  
Gender  
[units: participants]
 
Female     16  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     30  
ISGA-Chronic Hand Dermatitis [1]
[units: Participants]
 
Mild     16  
Moderate     14  
Time since Diagnosis of Chronic Hand Dermatitis (years) [2]
[units: Years]
Mean ± Standard Deviation
  18.92  ± 15  
Total Hand Eczema Severity Index (HESI) [3]
[units: Units on a scale]
Mean ± Standard Deviation
  32.1  ± 17.0  
[1] Investigators Static Global Assessment (ISGA)- Chronic Hand Dermatitis Score=2 mild Score=3 moderate These are the only scores that are permitted for entry on this study.
[2] Time since Diagnosis of Chronic Hand Dermatitis, Allergic, Irritant or Contact Dermatitis (years)
[3] Total Hand Eczema Severity Index (total HESI) Score 0 to 360 where 0 is the best and 360 is the worst score.



  Outcome Measures
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1.  Primary:   Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score   [ Time Frame: Baseline, Day 15 ]

2.  Secondary:   Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.   [ Time Frame: Baseline, Day 8 ]

3.  Secondary:   Change in Subject’s Visual Analogue Assessment Scale   [ Time Frame: Baseline, Day 8 ]

4.  Secondary:   Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips   [ Time Frame: Baseline, Day 15 ]

5.  Secondary:   Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips   [ Time Frame: Baseline, Day 8 ]

6.  Secondary:   Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers   [ Time Frame: Baseline, Day 15 ]

7.  Secondary:   Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers   [ Time Frame: Baseline, Day 8 ]

8.  Secondary:   Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands   [ Time Frame: Baseline, Day 8 ]

9.  Secondary:   Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands   [ Time Frame: Baseline, Day 15 ]

10.  Secondary:   Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands   [ Time Frame: Baseline, Day 8 ]

11.  Secondary:   Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands   [ Time Frame: Baseline, Day 15 ]

12.  Secondary:   Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists   [ Time Frame: Baseline, Day 8 ]

13.  Secondary:   Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists   [ Time Frame: Baseline, Day 15 ]

14.  Secondary:   Change in Subject’s Visual Analogue Assessment Scale From Baseline to Day 15   [ Time Frame: Baseline, Day 15 ]


  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
Open label study


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00828464     History of Changes
Other Study ID Numbers: U0280-401
Study First Received: January 22, 2009
Results First Received: April 7, 2010
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board