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Trial record 29 of 31 for:    ACITRETIN

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

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ClinicalTrials.gov Identifier: NCT01761019
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Laura Ferris, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Taclonex Topical Suspension
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description

Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks

Taclonex Topical Suspension: topical medication for psoriasis

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description

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 Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
51.375
(38 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Investigator Global Assessment
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.13  (0.35)
2.Secondary Outcome
Title Body Surface Area
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage of body surface area
0.7  (0.69)
3.Secondary Outcome
Title Safety
Hide Description Throughout this study, adverse events and serious adverse events will be collected
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: adverse event
1
4.Secondary Outcome
Title Patient Satisfaction
Hide Description • 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.63  (0.52)
5.Secondary Outcome
Title Desire to Change to Another Systemic Therapy
Hide Description We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Percentage of participants
0
Time Frame 1 year, 9 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Taclonex Topical Suspension
Hide Arm/Group Description

Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks

Taclonex Topical Suspension: topical medication for psoriasis

All-Cause Mortality
Taclonex Topical Suspension
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Taclonex Topical Suspension
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Taclonex Topical Suspension
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Infection *  1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
The greatest limitation of this study was the small sample size. Other study limitations include the open label, non-randomized design and absence of a placebo arm.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura K. Ferris, MD, PhD
Organization: Department of Dermatology, University of Pittsburgh School of Medicine
Phone: 412-647-2013
EMail: ferrlk@upmc.edu
Layout table for additonal information
Responsible Party: Laura Ferris, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01761019     History of Changes
Other Study ID Numbers: PRO12100308
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: September 17, 2015
Results First Posted: September 21, 2016
Last Update Posted: September 21, 2016