Mechanistically-based Optimization of UV Radiation Therapy in Psoriasis

This study has been terminated.
(Recruiting complete and administrative termination)
Sponsor:
Collaborator:
University Hospital Case Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00470392
First received: May 4, 2007
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: September 26, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Subject)
Condition: Psoriasis
Interventions: Drug: Imiquimod
Drug: Clobetasol

  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
Subjects were recruited from the Dermatology clinics at University Hospitals Case Medical Center and the Louis Stokes Cleveland VAMC.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with moderate to severe psoriasis were recruited from May 2007 to July 2012. 23 subjects were screened but only 9 were assigned to a study arm and received treatment. Per protocol, subjects underwent a washout period of 1 week for topical treatments and 1 month for systemic treatments prior to pre-treatment with Imiquimod or Clobetasol.

Reporting Groups
  Description
Imiquimod Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
Clobetasol Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.

Participant Flow:   Overall Study
    Imiquimod     Clobetasol  
STARTED     7 [1]   2 [1]
COMPLETED     7     2  
NOT COMPLETED     0     0  
[1] Number of subjects enrolled, passed screening and assigned to this arm.



  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
Imiquimod Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
Clobetasol Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
Total Total of all reporting groups

Baseline Measures
    Imiquimod     Clobetasol     Total  
Number of Participants  
[units: participants]
  7     2     9  
Age, Customized  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 80 years     7     2     9  
>=80 years     0     0     0  
Gender  
[units: participants]
     
Female     4     0     4  
Male     3     2     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Elevated MyxA   [ Time Frame: Biopsy samples for analysis were taken 1 hour post UVB treatment ]

2.  Secondary:   Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment   [ Time Frame: 2 weeks after Imiquimod and UVB ]

3.  Secondary:   Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2   [ Time Frame: Biopsy samples for analysis were taken 1 hour post UVB treatment ]


  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
No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.


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


Results Point of Contact:  
Name/Title: Kevin D. Cooper MD
Organization: Louis Stokes VA Medical Center and University Hospitals Case Medical Center
phone: 216 844 3111
e-mail: kevin.cooper@uhhospitals.org


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00470392     History of Changes
Other Study ID Numbers: IMMB-004-06S
Study First Received: May 4, 2007
Results First Received: September 26, 2013
Last Updated: February 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration