Trial Outcomes & Findings for Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp (NCT NCT00881868)
NCT ID: NCT00881868
Last Updated: 2022-08-25
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
baseline to week 4
Results posted on
2022-08-25
Participant Flow
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.
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
Participant milestones
| Measure |
Clobex Spray
|
Vehicle Spray
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
33
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Clobex Spray
|
Vehicle Spray
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
Baseline characteristics by cohort
| Measure |
Clobex Spray
n=41 Participants
|
Vehicle Spray
n=40 Participants
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 15.41 • n=99 Participants
|
41.3 years
STANDARD_DEVIATION 13.72 • n=107 Participants
|
43.7 years
STANDARD_DEVIATION 14.69 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to week 4Population: ITT, LOCF
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).
Outcome measures
| Measure |
Clobex Spray
n=41 Participants
|
Vehicle Spray
n=40 Participants
|
|---|---|---|
|
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)
Success
|
35 participants
|
5 participants
|
|
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)
Failure
|
6 participants
|
35 participants
|
SECONDARY outcome
Timeframe: baseline to week 4Number 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.
Outcome measures
| Measure |
Clobex Spray
n=41 Participants
|
Vehicle Spray
n=40 Participants
|
|---|---|---|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Baseline None (0)
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Week 4 None (0)
|
24 participants
|
3 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Baseline Mild (1)
|
4 participants
|
2 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Week 4 Mild (1)
|
15 participants
|
9 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Baseline Moderate (2)
|
22 participants
|
26 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Week 4 Moderate (2)
|
1 participants
|
21 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Baseline Severe (3)
|
12 participants
|
11 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Week 4 Severe (3)
|
1 participants
|
7 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Baseline Very Severe (4)
|
3 participants
|
1 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Scaling Week 4 Very Severe (4)
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Baseline None (0)
|
0 participants
|
1 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Week 4 None (0)
|
24 participants
|
3 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Baseline Mild (1)
|
3 participants
|
4 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Week 4 Mild (1)
|
14 participants
|
11 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Baseline Moderate (2)
|
30 participants
|
26 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Week 4 Moderate (2)
|
3 participants
|
20 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Baseline Severe (3)
|
8 participants
|
9 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Week 4 Severe (3)
|
0 participants
|
6 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Baseline Very Severe (4)
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Erythema Week 4 Very Severe (4)
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Baseline None (0)
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Week 4 None (0)
|
26 participants
|
7 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Baseline Mild (1)
|
7 participants
|
2 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Week 4 Mild (1)
|
13 participants
|
12 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Baseline Moderate (2)
|
19 participants
|
27 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Week 4 Moderate (2)
|
1 participants
|
19 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Baseline Severe (3)
|
13 participants
|
11 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Week 4 Severe (3)
|
1 participants
|
2 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Baseline Very Severe (4)
|
2 participants
|
0 participants
|
|
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
Plaque Elevation Week 4 Very Severe (4)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline to week 4Number 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.
Outcome measures
| Measure |
Clobex Spray
n=41 Participants
|
Vehicle Spray
n=40 Participants
|
|---|---|---|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Baseline None
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Week 4 None
|
21 participants
|
1 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Baseline <20%
|
16 participants
|
12 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Week 4 <20%
|
16 participants
|
16 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Baseline 20-39%
|
5 participants
|
6 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Week 4 20-39%
|
4 participants
|
12 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Baseline 40-59%
|
12 participants
|
14 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Week 4 40-59%
|
0 participants
|
4 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Baseline 60-79%
|
6 participants
|
5 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Week 4 60-79%
|
0 participants
|
5 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Baseline 80-100%
|
2 participants
|
3 participants
|
|
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
Extent of Scalp Involvement Week 4 80-100%
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: baseline to week 4Number 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.
Outcome measures
| Measure |
Clobex Spray
n=41 Participants
|
Vehicle Spray
n=40 Participants
|
|---|---|---|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Baseline None (0)
|
4 participants
|
1 participants
|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Week 4 None (0)
|
28 participants
|
8 participants
|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Baseline Mild (1)
|
5 participants
|
10 participants
|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Week 4 Mild (1)
|
12 participants
|
14 participants
|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Baseline Moderate (2)
|
29 participants
|
24 participants
|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Week 4 Moderate (2)
|
1 participants
|
14 participants
|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Baseline Severe (3)
|
3 participants
|
5 participants
|
|
Number of Participants in Each Category of Pruritus at Baseline and Week 4
Pruritus Week 4 Severe (3)
|
0 participants
|
4 participants
|
Adverse Events
Clobex Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ronald W. Gottschalk, MD / Medical Director
Galderma Laboratories, L.P.
Phone: 817-961-5358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER