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Trial record 9 of 810 for:    Psoriasis 4

Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

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ClinicalTrials.gov Identifier: NCT00881868
Recruitment Status : Completed
First Posted : April 15, 2009
Results First Posted : December 23, 2010
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: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Scalp Psoriasis
Interventions Drug: clobetasol propionate spray 0.05%
Drug: Vehicle spray
Enrollment 81
Recruitment Details

Dates of recruitment period: First subject was enrolled on April 20, 2009 and the last subject was enrolled on November 17, 2009.

Types of location: Investigative sites were located at private physician offices.

Pre-assignment Details Wash-out period to baseline: 14 days: chemical hair process, steroid medication and/or ultraviolet B (UVB) treatment, calcipotriene, other vitamin D analogs, Anthralin/tar, all other anti-psoriasis medications; 4 wks: psoralen & UVA (PUVA) treatment & treatments other than biologics with possible efficacy on psoriasis; 12 wks: biological therapies
Arm/Group Title Clobex Spray Vehicle Spray
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 41 40
Completed 33 38
Not Completed 8 2
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             2             1
Physician Decision             4             0
Protocol Violation             2             0
Arm/Group Title Clobex Spray Vehicle Spray Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 81 participants
46.0  (15.41) 41.3  (13.72) 43.7  (14.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
25
  61.0%
24
  60.0%
49
  60.5%
Male
16
  39.0%
16
  40.0%
32
  39.5%
1.Primary Outcome
Title Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)
Hide Description Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).
Time Frame baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobex Spray Vehicle Spray
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: participants
Success 35 5
Failure 6 35
2.Secondary Outcome
Title Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Time Frame baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clobex Spray Vehicle Spray
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: participants
Scaling Baseline None (0) 0 0
Scaling Week 4 None (0) 24 3
Scaling Baseline Mild (1) 4 2
Scaling Week 4 Mild (1) 15 9
Scaling Baseline Moderate (2) 22 26
Scaling Week 4 Moderate (2) 1 21
Scaling Baseline Severe (3) 12 11
Scaling Week 4 Severe (3) 1 7
Scaling Baseline Very Severe (4) 3 1
Scaling Week 4 Very Severe (4) 0 0
Erythema Baseline None (0) 0 1
Erythema Week 4 None (0) 24 3
Erythema Baseline Mild (1) 3 4
Erythema Week 4 Mild (1) 14 11
Erythema Baseline Moderate (2) 30 26
Erythema Week 4 Moderate (2) 3 20
Erythema Baseline Severe (3) 8 9
Erythema Week 4 Severe (3) 0 6
Erythema Baseline Very Severe (4) 0 0
Erythema Week 4 Very Severe (4) 0 0
Plaque Elevation Baseline None (0) 0 0
Plaque Elevation Week 4 None (0) 26 7
Plaque Elevation Baseline Mild (1) 7 2
Plaque Elevation Week 4 Mild (1) 13 12
Plaque Elevation Baseline Moderate (2) 19 27
Plaque Elevation Week 4 Moderate (2) 1 19
Plaque Elevation Baseline Severe (3) 13 11
Plaque Elevation Week 4 Severe (3) 1 2
Plaque Elevation Baseline Very Severe (4) 2 0
Plaque Elevation Week 4 Very Severe (4) 0 0
3.Secondary Outcome
Title Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Hide Description Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.
Time Frame baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clobex Spray Vehicle Spray
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: participants
Extent of Scalp Involvement Baseline None 0 0
Extent of Scalp Involvement Week 4 None 21 1
Extent of Scalp Involvement Baseline <20% 16 12
Extent of Scalp Involvement Week 4 <20% 16 16
Extent of Scalp Involvement Baseline 20-39% 5 6
Extent of Scalp Involvement Week 4 20-39% 4 12
Extent of Scalp Involvement Baseline 40-59% 12 14
Extent of Scalp Involvement Week 4 40-59% 0 4
Extent of Scalp Involvement Baseline 60-79% 6 5
Extent of Scalp Involvement Week 4 60-79% 0 5
Extent of Scalp Involvement Baseline 80-100% 2 3
Extent of Scalp Involvement Week 4 80-100% 0 2
4.Secondary Outcome
Title Number of Participants in Each Category of Pruritus at Baseline and Week 4
Hide Description Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.
Time Frame baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clobex Spray Vehicle Spray
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: participants
Pruritus Baseline None (0) 4 1
Pruritus Week 4 None (0) 28 8
Pruritus Baseline Mild (1) 5 10
Pruritus Week 4 Mild (1) 12 14
Pruritus Baseline Moderate (2) 29 24
Pruritus Week 4 Moderate (2) 1 14
Pruritus Baseline Severe (3) 3 5
Pruritus Week 4 Severe (3) 0 4
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 Clobex Spray Vehicle Spray
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Clobex Spray Vehicle Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clobex Spray Vehicle Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clobex Spray Vehicle Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/40 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5358
EMail: ron.gottschalk@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00881868     History of Changes
Other Study ID Numbers: US10118
First Submitted: April 13, 2009
First Posted: April 15, 2009
Results First Submitted: December 16, 2010
Results First Posted: December 23, 2010
Last Update Posted: October 2, 2012