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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00881868
• Collaborator: (none)
• Enrollment: 81
• Locations: 4
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 20.3
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.

Condition or Disease	Intervention/Treatment	Phase
Scalp Psoriasis	Drug: clobetasol propionate spray 0.05%; Drug: Vehicle spray	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Clobetasol Propionate Spray Versus Vehicle for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clobex Spray	Drug: clobetasol propionate spray 0.05%; Apply enough product to cover affected areas topically twice daily at least 8 hours apart; Other Names: Clobex® Spray 0.05%
Placebo Comparator: Vehicle spray	Drug: Vehicle spray; Apply enough product to cover affected areas topically twice daily at least 8 hours apart

Outcome Measures

Primary Outcome Measures

1. 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) [baseline to week 4]

   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).

Secondary Outcome Measures

1. Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 [baseline to week 4]

   Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.

2. Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 [baseline to week 4]

   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.

3. Number of Participants in Each Category of Pruritus at Baseline and Week 4 [baseline to week 4]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp

Exclusion Criteria:

• Subjects who need systemic treatment for their body psoriasis

• Subjects who have surface area involvement too large (>20% Body Surface Area [BSA]) that would require more than 50 grams per week of study product

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Research Associates	Los Angeles	California	United States	90045
2	Hudson Dermatology	Evansville	Indiana	United States	47714
3	Research Division of The Skin Specialty Group	New York	New York	United States	10155
4	Dermatology Associates, PLLC	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ronald W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT00881868
• Other Study ID Numbers: US10118
• First Posted: Apr 15, 2009
• Last Update Posted: Aug 25, 2022
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Psoriasis; Clobetasol

Study Results

Participant Flow

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 Detail	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
Arm/Group Description
Period Title: Overall Study
STARTED	41	40
COMPLETED	33	38
NOT COMPLETED	8	2

Baseline Characteristics

Arm/Group Title	Clobex Spray	Vehicle Spray	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	41	40	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.0 (15.41)	41.3 (13.72)	43.7 (14.69)
Sex: Female, Male (Count of Participants)
Female	25 61%	24 60%	49 60.5%
Male	16 39%	16 40%	32 39.5%

Outcome Measures

1. 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
Description	Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.
Time Frame	baseline to week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clobex Spray	Vehicle Spray
Arm/Group Description
Measure Participants	41	40
Scaling Baseline None (0)	0 0%	0 0%
Scaling Week 4 None (0)	24 58.5%	3 7.5%
Scaling Baseline Mild (1)	4 9.8%	2 5%
Scaling Week 4 Mild (1)	15 36.6%	9 22.5%
Scaling Baseline Moderate (2)	22 53.7%	26 65%
Scaling Week 4 Moderate (2)	1 2.4%	21 52.5%
Scaling Baseline Severe (3)	12 29.3%	11 27.5%
Scaling Week 4 Severe (3)	1 2.4%	7 17.5%
Scaling Baseline Very Severe (4)	3 7.3%	1 2.5%
Scaling Week 4 Very Severe (4)	0 0%	0 0%
Erythema Baseline None (0)	0 0%	1 2.5%
Erythema Week 4 None (0)	24 58.5%	3 7.5%
Erythema Baseline Mild (1)	3 7.3%	4 10%
Erythema Week 4 Mild (1)	14 34.1%	11 27.5%
Erythema Baseline Moderate (2)	30 73.2%	26 65%
Erythema Week 4 Moderate (2)	3 7.3%	20 50%
Erythema Baseline Severe (3)	8 19.5%	9 22.5%
Erythema Week 4 Severe (3)	0 0%	6 15%
Erythema Baseline Very Severe (4)	0 0%	0 0%
Erythema Week 4 Very Severe (4)	0 0%	0 0%
Plaque Elevation Baseline None (0)	0 0%	0 0%
Plaque Elevation Week 4 None (0)	26 63.4%	7 17.5%
Plaque Elevation Baseline Mild (1)	7 17.1%	2 5%
Plaque Elevation Week 4 Mild (1)	13 31.7%	12 30%
Plaque Elevation Baseline Moderate (2)	19 46.3%	27 67.5%
Plaque Elevation Week 4 Moderate (2)	1 2.4%	19 47.5%
Plaque Elevation Baseline Severe (3)	13 31.7%	11 27.5%
Plaque Elevation Week 4 Severe (3)	1 2.4%	2 5%
Plaque Elevation Baseline Very Severe (4)	2 4.9%	0 0%
Plaque Elevation Week 4 Very Severe (4)	0 0%	0 0%

2. Secondary Outcome

Title	Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clobex Spray	Vehicle Spray
Arm/Group Description
Measure Participants	41	40
Extent of Scalp Involvement Baseline None	0 0%	0 0%
Extent of Scalp Involvement Week 4 None	21 51.2%	1 2.5%
Extent of Scalp Involvement Baseline <20%	16 39%	12 30%
Extent of Scalp Involvement Week 4 <20%	16 39%	16 40%
Extent of Scalp Involvement Baseline 20-39%	5 12.2%	6 15%
Extent of Scalp Involvement Week 4 20-39%	4 9.8%	12 30%
Extent of Scalp Involvement Baseline 40-59%	12 29.3%	14 35%
Extent of Scalp Involvement Week 4 40-59%	0 0%	4 10%
Extent of Scalp Involvement Baseline 60-79%	6 14.6%	5 12.5%
Extent of Scalp Involvement Week 4 60-79%	0 0%	5 12.5%
Extent of Scalp Involvement Baseline 80-100%	2 4.9%	3 7.5%
Extent of Scalp Involvement Week 4 80-100%	0 0%	2 5%

3. Secondary Outcome

Title	Number of Participants in Each Category of Pruritus at Baseline and Week 4
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clobex Spray	Vehicle Spray
Arm/Group Description
Measure Participants	41	40
Pruritus Baseline None (0)	4 9.8%	1 2.5%
Pruritus Week 4 None (0)	28 68.3%	8 20%
Pruritus Baseline Mild (1)	5 12.2%	10 25%
Pruritus Week 4 Mild (1)	12 29.3%	14 35%
Pruritus Baseline Moderate (2)	29 70.7%	24 60%
Pruritus Week 4 Moderate (2)	1 2.4%	14 35%
Pruritus Baseline Severe (3)	3 7.3%	5 12.5%
Pruritus Week 4 Severe (3)	0 0%	4 10%

4. 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)
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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobex Spray	Vehicle Spray
Arm/Group Description
Measure Participants	41	40
Success	35 85.4%	5 12.5%
Failure	6 14.6%	35 87.5%

Adverse Events

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
Arm/Group Description
All Cause Mortality
	Clobex Spray		Vehicle Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Clobex Spray		Vehicle Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Clobex Spray		Vehicle Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.