Trial Outcomes & Findings for A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy (NCT NCT01761019)

Results Overview

This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Taclonex Topical Suspension Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Taclonex Topical Suspension n=8 Participants Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.375 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.

Outcome measures

Outcome measures
Measure	Taclonex Topical Suspension n=8 Participants Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Investigator Global Assessment	1.13 units on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: 12 weeks

This is a measure of the percentage of the body involved with psoriasis. We will measure the change in percentage of body area involved with psoriasis from baseline to week 12.

Outcome measures

Outcome measures
Measure	Taclonex Topical Suspension n=8 Participants Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Body Surface Area	0.7 percentage of body surface area Standard Deviation 0.69

SECONDARY outcome

Timeframe: 12 weeks

Throughout this study, adverse events and serious adverse events will be collected

Outcome measures

Outcome measures
Measure	Taclonex Topical Suspension n=8 Participants Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Safety	1 adverse event

SECONDARY outcome

Timeframe: 12 weeks

• Subject satisfaction: We also ask subjects for their level of satisfaction with their current treatment at week 12. They will be given the following options: "very satisfied", "satisfied", "somewhat disappointed" or "very disappointed". For measurement "very satisfied"=4, "satisfied"=3, "somewhat disappointed"=2 and "very disappointed"=1. We will determine the mean satisfaction of all patients at week 12.

Outcome measures

Outcome measures
Measure	Taclonex Topical Suspension n=8 Participants Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Patient Satisfaction	3.63 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: 12 weeks

We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.

Outcome measures

Outcome measures
Measure	Taclonex Topical Suspension n=8 Participants Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Desire to Change to Another Systemic Therapy	0 Percentage of participants

Adverse Events

Taclonex Topical Suspension

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Taclonex Topical Suspension n=8 participants at risk Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Taclonex Topical Suspension: topical medication for psoriasis
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	12.5% 1/8 • Number of events 1 • 1 year, 9 months.

Additional Information

Laura K. Ferris, MD, PhD

Department of Dermatology, University of Pittsburgh School of Medicine

Phone: 412-647-2013

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place