Trial Outcomes & Findings for Topical Psoriasis Study for Patients Receiving Biologic Therapy (NCT NCT02983981)

NCT ID: NCT02983981

Last Updated: 2024-03-20

Results Overview

Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2024-03-20

Participant Flow

Participant milestones

Measure	Topicort Topical Spray Topicort spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Psoriasis Study for Patients Receiving Biologic Therapy

Baseline characteristics by cohort

Measure	Open Label n=20 Participants Topicort topical spray Topicort Topical Spray: open label Topicort spray applied twice daily for 4 weeks followed by twice daily BID on two consecutive days a week (e.g. Saturday and Sunday) for 12 weeks.
Age, Continuous	53.33 years STANDARD_DEVIATION 7.92 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.

Outcome measures

Measure	Open Label n=20 Participants Topicort topical spray Topicort Topical Spray: open label Topicort spray
Psoriasis Severity	4.25 units on a scale Standard Deviation 5.71

SECONDARY outcome

Timeframe: 16 weeks

Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis

Outcome measures

Measure	Open Label n=20 Participants Topicort topical spray Topicort Topical Spray: open label Topicort spray
Psoriasis Severity	1.65 units on a scale Standard Deviation .89

SECONDARY outcome

Timeframe: 16 weeks

Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.

Outcome measures

Measure	Open Label n=20 Participants Topicort topical spray Topicort Topical Spray: open label Topicort spray
Psoriasis Severity	2.05 percentage of BSA Standard Deviation 2.28

SECONDARY outcome

Timeframe: 16 weeks

calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Outcome measures

Measure	Open Label n=20 Participants Topicort topical spray Topicort Topical Spray: open label Topicort spray
Dermatology Life Quality Index	3.65 units on a scale Standard Deviation 4.08

Adverse Events

Open Label

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open Label n=20 participants at risk Topicort topical spray Topicort Topical Spray: open label Topicort spray
Skin and subcutaneous tissue disorders worsening of psoriasis	10.0% 2/20 • Number of events 2
Skin and subcutaneous tissue disorders erythema multiforme	5.0% 1/20 • Number of events 1
Cardiac disorders hypertension	5.0% 1/20 • Number of events 1
Nervous system disorders sciatic neuralgia	5.0% 1/20 • Number of events 1
Infections and infestations cough/congestion	5.0% 1/20 • Number of events 1
Metabolism and nutrition disorders hyperglycemia	5.0% 1/20 • Number of events 1

Additional Information

Jerry Bagel Director of Clinical Trials

Psoriasis Treatment Center of Central New Jersey

Phone: 6094434500

Email: dreamacres1@aol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place