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Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00988637
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : June 3, 2011
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen
Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen
Enrollment 138

Recruitment Details Dates of recruitment period: First subject was enrolled on October 26, 2009 and the last subject was enrolled on January 28, 2010.
Pre-assignment Details Wash-out period up to baseline is 30 days for any steroid containing medication, dovonex, anthralin, tar and/or ultraviolet B (UVB) treatment; 12 weeks for corticosteroids, biologics and/or psoralen + ultraviolet A (PUVA) treatment.
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Period Title: Overall Study
Started 70 68
Completed 67 65
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             2             1
Withdrawal by Subject             1             1
non-compliance with study drug             0             1
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening) Total
Hide Arm/Group Description Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen Total of all reporting groups
Overall Number of Baseline Participants 70 68 138
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 68 participants 138 participants
46.4  (14.03) 44.5  (14.43) 45.4  (14.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 68 participants 138 participants
Female
27
  38.6%
24
  35.3%
51
  37.0%
Male
43
  61.4%
44
  64.7%
87
  63.0%
1.Primary Outcome
Title Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4
Hide Description Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
14 28
2.Secondary Outcome
Title Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2
Hide Description Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame Baseline to week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
9 14
3.Secondary Outcome
Title Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Hide Description Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Symptoms worse (-1) 1 0
No change (0) 2 6
Minimal Improvement (1) 9 6
Definite Improvement (2) 25 10
Considerable Improvement (3) 19 18
Clearing (4) 13 25
Missing 1 3
4.Secondary Outcome
Title Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Hide Description Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat; LOCF (Last Observation Carried Forward)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Clear (0) 5 4
Almost Clear (1) 6 15
Mild (2) 31 32
Moderate (3) 28 17
Severe/Very Severe (4) 0 0
5.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Hide Description Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Clear (0) 12 20
Almost Clear (1) 24 20
Mild (2) 28 23
Moderate (3) 6 5
Severe (4) 0 0
6.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Hide Description Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Clear (0) 6 11
Almost Clear (1) 15 24
Mild (2) 33 26
Moderate (3) 16 7
Severe/Very Severe (4) 0 0
7.Secondary Outcome
Title Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4
Hide Description Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Median (Standard Deviation)
Unit of Measure: Percent change
-33.3  (31.85) -50.0  (30.15)
8.Secondary Outcome
Title Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4
Hide Description Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-24.8  (22.81) -27.5  (27.10)
9.Secondary Outcome
Title Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Hide Description Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "The treatment program was easy to follow" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Strongly agree 61 59
Moderately agree 2 8
No opinion 2 0
Moderately disagree 2 0
Strongly disagree 0 0
Missing 3 1
10.Secondary Outcome
Title Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Hide Description Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am Satisfied with my Appearance" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Strongly agree 10 25
Moderately agree 39 32
No opinion 6 4
Moderately disagree 9 5
Strongly disagree 3 1
Missing 3 1
11.Secondary Outcome
Title Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Hide Description Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am satisfied with the results of this treatment program" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Strongly agree 23 42
Moderately agree 35 20
No opinion 5 1
Moderately disagree 3 4
Strongly disagree 1 0
Missing 3 1
12.Secondary Outcome
Title Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Hide Description Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I would use this treatment program again if recommended by the dermatologist" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat)
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
Strongly agree 37 50
Moderately agree 21 16
No opinion 3 0
Moderately disagree 2 1
Strongly disagree 4 0
Missing 3 1
13.Secondary Outcome
Title Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4
Hide Description Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.
Time Frame Baseline to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description:
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: participants
4 2
Time Frame 4 weeks
Adverse Event Reporting Description Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
 
Arm/Group Title Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Hide Arm/Group Description Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
All-Cause Mortality
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/68 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/70 (5.71%)      0/68 (0.00%)    
Infections and infestations     
Upper respiratory tract infection * 1 [1]  4/70 (5.71%)  4 0/68 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
[1]
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
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 principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
Results Point of Contact
Name/Title: Ronald W. Gottschalk, MD / Medical Dierctor
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5358
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00988637     History of Changes
Other Study ID Numbers: US10144
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: March 30, 2011
Results First Posted: June 3, 2011
Last Update Posted: October 2, 2012