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Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

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.
 
ClinicalTrials.gov Identifier: NCT00658788
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: clobetasol propionate spray 0.05%
Drug: calcitriol ointment
Enrollment 305
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequential Treatment Regimen
Hide Arm/Group Description 4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
Period Title: Overall Study
Started 305
Completed 231
Not Completed 74
Reason Not Completed
Adverse Event             11
Withdrawal by Subject             13
Lost to Follow-up             18
Treatment Discontinuation             32
Arm/Group Title Sequential Treatment Regimen
Hide Arm/Group Description 4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Baseline Participants 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants
48.6  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants
Female
118
  38.7%
Male
187
  61.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants
Hispanic or Latino
27
   8.9%
Not Hispanic or Latino
278
  91.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants
American Indian or Alaska Native
1
   0.3%
Asian
9
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
   3.3%
White
273
  89.5%
More than one race
12
   3.9%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Overall Disease Severity Success (ODS)
Hide Description Success was defined as a one-grade improvement in ODS from baseline.
Time Frame 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.
Arm/Group Title Sequential Treatment Regimen
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 170
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 8
100.0
(97.9 to 100.0)
Week 12
84.1
(77.7 to 89.3)
2.Secondary Outcome
Title Global Improvement Score
Hide Description [Not Specified]
Time Frame 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 170 170 170 170
Measure Type: Number
Unit of Measure: participants
-1:Symptoms 1 0 0 0
0:No Change 4 2 10 13
1:Minimal Improvement 9 4 12 19
2:Definite Improvement 53 26 43 49
3:Considerable Improvement 93 96 77 58
4:Clearing 11 42 28 31
3.Secondary Outcome
Title Signs of Psoriasis - Erythema
Hide Description [Not Specified]
Time Frame 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 170 170 170 170
Measure Type: Number
Unit of Measure: participants
Clear 0 9 13 12
Almost Clear 46 81 53 41
Mild 82 57 70 60
Moderate 35 23 32 53
Severe/Very Severe 7 0 2 4
4.Secondary Outcome
Title Signs of Psoriasis - Scaling
Hide Description [Not Specified]
Time Frame 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 170 170 170 170
Measure Type: Number
Unit of Measure: participants
Clear 25 41 36 31
Almost Clear 61 83 53 56
Mild 63 37 71 54
Moderate 19 9 9 26
Severe/Very Severe 4 0 1 3
5.Secondary Outcome
Title Signs of Psoriasis - Plaque Elevation
Hide Description [Not Specified]
Time Frame 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 170 170 170 170
Measure Type: Number
Unit of Measure: participants
Clear 22 46 35 24
Almost Clear 69 78 50 45
Mild 54 36 68 61
Moderate 24 9 17 39
Severe/Very Severe 1 1 0 1
6.Secondary Outcome
Title Percent Change From Baseline in Body Surface Area (% BSA) Affected
Hide Description [Not Specified]
Time Frame 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 170 170 170 170
Mean (Standard Deviation)
Unit of Measure: Percent Change from Baseline
20.1  (23.6) 43.1  (30.9) 46.6  (31.1) 46.2  (36.1)
7.Secondary Outcome
Title Overall Disease Severity
Hide Description [Not Specified]
Time Frame 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 170 170 170 170
Measure Type: Number
Unit of Measure: participants
Clear 0 5 9 11
Almost Clear 53 100 60 45
Mild 83 53 88 70
Moderate 31 12 13 44
Severe/Very Severe 3 0 0 0
8.Secondary Outcome
Title Tolerability Assessment - Pruritus
Hide Description [Not Specified]
Time Frame Baseline, 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 305 288 285 274 235
Measure Type: Number
Unit of Measure: participants
None 74 179 220 172 128
Mild 84 91 56 66 65
Moderate 84 13 9 31 32
Severe 63 5 0 5 10
9.Secondary Outcome
Title Tolerability Assessment - Telangiectasias
Hide Description [Not Specified]
Time Frame Baseline, 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 305 288 285 274 235
Measure Type: Number
Unit of Measure: participants
None 303 284 283 273 230
Mild 1 4 2 1 5
Moderate 0 0 0 0 0
Severe 1 0 0 0 0
10.Secondary Outcome
Title Tolerability Assessment - Stinging/ Burning
Hide Description [Not Specified]
Time Frame Baseline, 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 305 288 285 274 235
Measure Type: Number
Unit of Measure: participants
None 200 232 245 234 200
Mild 44 42 34 18 24
Moderate 31 13 4 19 8
Severe 30 1 1 3 3
11.Secondary Outcome
Title Tolerability Assessment - Skin Atrophy
Hide Description [Not Specified]
Time Frame Baseline, 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 305 288 285 274 235
Measure Type: Number
Unit of Measure: participants
Absent 303 286 278 270 233
Present 2 2 7 4 2
12.Secondary Outcome
Title Tolerability Assessment - Folliculitis
Hide Description [Not Specified]
Time Frame Baseline, 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 2 Week 4 Week 8 Week 12
Hide Arm/Group Description:
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
Overall Number of Participants Analyzed 305 288 285 274 235
Measure Type: Number
Unit of Measure: participants
Absent 303 286 274 271 232
Present 2 2 11 3 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sequential Treatment Regimen
Hide Arm/Group Description 4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
All-Cause Mortality
Sequential Treatment Regimen
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Sequential Treatment Regimen
Affected / at Risk (%)
Total   9/305 (2.95%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage * 1  1/305 (0.33%) 
Infections and infestations   
Pneumonia * 1  1/305 (0.33%) 
Injury, poisoning and procedural complications   
Accidental Overdose * 1  1/305 (0.33%) 
Fall * 1  1/305 (0.33%) 
Spinal cord injury cervical * 1  1/305 (0.33%) 
Nervous system disorders   
Hemiplegia * 1  1/305 (0.33%) 
Psychiatric disorders   
Attention deficit/hyperactivity disorder * 1  1/305 (0.33%) 
Bipolar disorder * 1  1/305 (0.33%) 
Depression * 1  1/305 (0.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sequential Treatment Regimen
Affected / at Risk (%)
Total   0/305 (0.00%) 
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth M Nieman
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5000
EMail: elizabeth.nieman@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00658788    
Other Study ID Numbers: US10085
First Submitted: March 4, 2008
First Posted: April 15, 2008
Results First Submitted: August 12, 2014
Results First Posted: August 27, 2014
Last Update Posted: August 27, 2014