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Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema (HANDEL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00817063
First Posted: January 6, 2009
Last Update Posted: November 9, 2017
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.
Collaborator:
Basilea Pharmaceutica
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
Results First Submitted: July 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Eczema
Interventions: Drug: alitretinoin
Drug: Placebo

  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
A total of 599 participants were randomized, out of these 3 participants did not receive study medication, hence Intent-to-treat (ITT) population consisted of 596 participants which included all randomized participants who were dispensed medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 942 participants entered the run-in period for a maximum of 16 weeks who received class 1 corticosteroids for 2 weeks followed by corticosteroids of any potency. Out of 942 participants, 343 participants were run-in failures and hence 599 were randomized in the study.

Reporting Groups
  Description
Alitretinoin 30 mg Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 milligrams (mg) of alitretinoin oral soft capsule once daily up to 24 weeks.
Placebo Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.

Participant Flow:   Overall Study
    Alitretinoin 30 mg   Placebo
STARTED   298   298 
COMPLETED   161   128 
NOT COMPLETED   137   170 
Adverse Event                32                13 
Death                1                1 
Lack of Efficacy                33                86 
Failure to Return                13                12 
Violation of Selection at Entry                7                4 
Protocol Violation                3                8 
Withdrawal by Subject                17                37 
Early Improvement                19                4 
Administrative                10                4 
Abnormality of Laboratory Test                2                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
Alitretinoin 30 mg Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
Placebo Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Alitretinoin 30 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 298   298   596 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.1  (12.55)   47.5  (12.96)   47.3  (12.75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      133  44.6%      149  50.0%      282  47.3% 
Male      165  55.4%      149  50.0%      314  52.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      6   2.0%      15   5.0%      21   3.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      19   6.4%      35  11.7%      54   9.1% 
White      263  88.3%      238  79.9%      501  84.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      10   3.4%      10   3.4%      20   3.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24   [ Time Frame: Week 24 (end-of-treatment) ]

2.  Secondary:   Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment   [ Time Frame: Baseline (Week 0) and Week 24 (end-of-treatment) ]

3.  Secondary:   Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment   [ Time Frame: Week 24 (end-of-treatment) ]

4.  Secondary:   Percentage Change From Baseline in Extent of Disease at End-of-treatment   [ Time Frame: Baseline (Week 0) and Week 24 (end-of-treatment) ]

5.  Secondary:   Response Duration for Responding Participants at the End-of-therapy   [ Time Frame: Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) ]

6.  Secondary:   Time to Relapse for Responding Participants at the End-of-therapy   [ Time Frame: Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) ]

7.  Secondary:   Time to Response for Responding Participants at End-of-therapy   [ Time Frame: Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) ]

8.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period   [ Time Frame: Up to Week 24 (end-of-treatment) ]

9.  Secondary:   Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range   [ Time Frame: Up to Week 28 ]

10.  Secondary:   Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks   [ Time Frame: Up to Week 24 ]

11.  Secondary:   Change From Baseline in Patient Health Questionnaire (PHQ-9) Score Over 28 Weeks   [ Time Frame: Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24, 28 ]

12.  Secondary:   Number of Participants Meeting the Referral Criteria of Psychiatric Evaluation Over 28 Weeks   [ Time Frame: Up to 28 Weeks ]

13.  Secondary:   Change From Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) Over 24 Weeks   [ Time Frame: Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24 ]

14.  Secondary:   Change From Baseline in Dizziness Handicap Inventory (DHI) Over 24 Weeks   [ Time Frame: Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24 ]

15.  Secondary:   Number of Participants Responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) Questionnaire Over 24 Weeks   [ Time Frame: Up to Week 24 ]

16.  Secondary:   Percent Change From Baseline in Bone Mineral Density (BMD) by Dual Energy X-ray Absorptiometry (DXA) Over 72 Weeks   [ Time Frame: Baseline (Week 0) and Week 72 ]

17.  Secondary:   Number of Participants With Adequecy of Images Assessed by X-ray Evaluation of Bones   [ Time Frame: Up to Week 72 ]

18.  Secondary:   Number of Participants With Adverse Ophthalmological Change as Assessed by Fundus Photography - Intraocular Pressure   [ Time Frame: Up to Week 24 ]

19.  Secondary:   Number of Participants With Adverse Audiological Change as Assessed by Puretone Audiogram at Highest Frequency   [ Time Frame: Up to Week 24 ]


  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
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  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00817063     History of Changes
Other Study ID Numbers: 117183
BAP01346 ( Other Identifier: Basilea Pharmaceutica )
First Submitted: January 5, 2009
First Posted: January 6, 2009
Results First Submitted: July 17, 2017
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017