Trial Outcomes & Findings for Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray (NCT NCT02985736)

Last Updated: 2024-04-09

Results Overview

Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-04-09

Participants were recruited from private practice dermatology

Of the 21 patients screened for participation, 20 subjects were enrolled to receive Open Label Topicort Topical Spray

Participant milestones
Measure	Topicort Topical Spray Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Topicort Topical Spray Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Overall Study Lost to Follow-up	3

Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

Baseline characteristics by cohort
Measure	Topicort Topical Spray n=20 Participants Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants
Age, Continuous	50 years n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants

Timeframe: 16 weeks

Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)

Outcome measures
Measure	Topicort Topical Spray n=20 Participants Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Investigator Global Assessment (Scalp Only)	1.59 score on a scale Interval 0.0 to 4.0

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Topicort Topical Spray n=20 participants at risk Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Skin and subcutaneous tissue disorders itching	15.0% 3/20 • Number of events 3 • 16 weeks
Skin and subcutaneous tissue disorders burning	25.0% 5/20 • Number of events 5 • 16 weeks
Infections and infestations sinusitis	10.0% 2/20 • Number of events 2 • 16 weeks
Skin and subcutaneous tissue disorders worsening of psoriasis	10.0% 2/20 • Number of events 2 • 16 weeks
Skin and subcutaneous tissue disorders Infected lesion	5.0% 1/20 • Number of events 1 • 16 weeks
Psychiatric disorders worsening of anxiety	5.0% 1/20 • Number of events 1 • 16 weeks
Skin and subcutaneous tissue disorders tinea	5.0% 1/20 • Number of events 1 • 16 weeks
Skin and subcutaneous tissue disorders acne	10.0% 2/20 • Number of events 2 • 16 weeks
Skin and subcutaneous tissue disorders folliculitis	5.0% 1/20 • Number of events 1 • 16 weeks
Respiratory, thoracic and mediastinal disorders COPD	5.0% 1/20 • Number of events 1 • 16 weeks

Psoriasis Treatment Center of Central New Jersey

Phone: 6094434500