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.

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

Scalp Psoriasis

clobetasol propionate spray 0.05%

Vehicle spray

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

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).

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.

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status