Trial Outcomes & Findings for Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05% (NCT NCT01893567)

Results Overview

Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

2 weeks

Results posted on

2022-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Clobex Spray Clobex Spray
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clobex Spray n=28 Participants Clobex Spray
Age, Continuous	55.2 years STANDARD_DEVIATION 12.8 • n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	28 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.

Outcome measures

Outcome measures
Measure	Clobex Spray n=28 Participants Clobex Spray
Subject Reported Target Lesion Severity Score.	4.0 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 2 weeks

Investigator reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study

Outcome measures

Outcome measures
Measure	Clobex Spray n=28 Participants Clobex Spray
Investigator Reported Target Lesion Severity Score	3.3 units on a scale Standard Deviation 2.1

Adverse Events

Clobex Spray

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Clobex Spray n=28 participants at risk Clobex Spray
Skin and subcutaneous tissue disorders Erythema	3.6% 1/28 • Number of events 1 • From baseline up to Day 15
Skin and subcutaneous tissue disorders Pruritus	3.6% 1/28 • Number of events 1 • From baseline up to Day 15
Skin and subcutaneous tissue disorders Skin exfoliation	3.6% 1/28 • Number of events 1 • From baseline up to Day 15
Skin and subcutaneous tissue disorders Skin plaque	3.6% 1/28 • Number of events 1 • From baseline up to Day 15
Musculoskeletal and connective tissue disorders Joint swelling	3.6% 1/28 • Number of events 1 • From baseline up to Day 15

Additional Information

Senior Clinical Project Manager

Galderma Laboratories, L.P.

Phone: 817-961-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place