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Mechanistically-based Optimization of UV Radiation Therapy in Psoriasis

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ClinicalTrials.gov Identifier: NCT00470392
Recruitment Status : Terminated (Recruiting complete and administrative termination)
First Posted : May 7, 2007
Results First Posted : February 12, 2014
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant)
Condition Psoriasis
Interventions Drug: Imiquimod
Drug: Clobetasol
Enrollment 9
Recruitment Details Subjects were recruited from the Dermatology clinics at University Hospitals Case Medical Center and the Louis Stokes Cleveland VAMC.
Pre-assignment Details 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.
Arm/Group Title Imiquimod Clobetasol
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 7 [1] 2 [1]
Completed 7 2
Not Completed 0 0
[1]
Number of subjects enrolled, passed screening and assigned to this arm.
Arm/Group Title Imiquimod Clobetasol Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 7 2 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 2 participants 9 participants
<=18 years 0 0 0
Between 18 and 80 years 7 2 9
>=80 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 2 participants 9 participants
Female
4
  57.1%
0
   0.0%
4
  44.4%
Male
3
  42.9%
2
 100.0%
5
  55.6%
1.Primary Outcome
Title Number of Subjects With Elevated MyxA
Time Frame Biopsy samples for analysis were taken 1 hour post UVB treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol.
Arm/Group Title Imiquimod Clobetasol
Hide Arm/Group Description:
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.
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. 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.
Overall Number of Participants Analyzed 7 0
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment
Hide Description The PASI is a disease burden measure that integrates area, erythema, thickness and scale of each target lesion. The severity score for each region is calculated by adding the scores for redness, thickness and scale (each of which are graded from 0 to 4). The maximum severity score is 12. The higher the PASI, the worse the disease. Thus, an improvement in PASI score is a lower score than the pre-treatment PASI.
Time Frame 2 weeks after Imiquimod and UVB
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol.
Arm/Group Title Imiquimod Clobetasol
Hide Arm/Group Description:
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.
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. 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.
Overall Number of Participants Analyzed 7 0
Measure Type: Number
Unit of Measure: participants
4
3.Secondary Outcome
Title Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2
Hide Description Based upon upregulated mRNA expression of MyxA in 1 out of 7 patients treated with Imiquimod, a list of alternative target genes responsive to Imiquimod was generated. The target mRNAs examined included GRAMD1A, IL2RA, TGHD1, DMXL2. The target gene was consider upregulated if there was a 1.5 fold increase in the mRNA expression of the target gene.
Time Frame Biopsy samples for analysis were taken 1 hour post UVB treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imiquimod Clobetasol
Hide Arm/Group Description:
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.

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.

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.

Overall Number of Participants Analyzed 7 0
Measure Type: Number
Unit of Measure: participants
1
Time Frame Adverse event data was collected for 30 days. The investigators assessed for adverse events at each study visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imiquimod Clobetasol
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Imiquimod Clobetasol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Imiquimod Clobetasol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Imiquimod Clobetasol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/7 (57.14%)      2/2 (100.00%)    
General disorders     
Hypertension  [1]  0/7 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations     
Common cold   0/7 (0.00%)  0 1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders     
Right knee trauma and pain   1/7 (14.29%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders     
Exacerbation of non-target psoriasis plaques during washout of topical medications   1/7 (14.29%)  1 1/2 (50.00%)  2
Grade 4 target site reaction - blistering post UVB   2/7 (28.57%)  2 0/2 (0.00%)  0
Contact vs irritant dermatitis surrounding target sites secondary to bandages   1/7 (14.29%)  1 0/2 (0.00%)  0
Grade 3 target site reaction - erythema with mild discomfort post UVB   1/7 (14.29%)  1 0/2 (0.00%)  0
Exacerbation of psoriasis surrounding target sites secondary to bandages   1/7 (14.29%)  1 0/2 (0.00%)  0
Burning sensation with use of study product   1/7 (14.29%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
evaluated and treated by the staff of the LSCVAMC Emergency Department
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.
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
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00470392     History of Changes
Other Study ID Numbers: IMMB-004-06S
First Submitted: May 4, 2007
First Posted: May 7, 2007
Results First Submitted: September 26, 2013
Results First Posted: February 12, 2014
Last Update Posted: October 5, 2016