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Topical Psoriasis Study for Patients Receiving Biologic Therapy

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ClinicalTrials.gov Identifier: NCT02983981
Recruitment Status : Completed
First Posted : December 6, 2016
Results First Posted : May 7, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Taro Pharmaceuticals USA
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Topicort Topical Spray
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topicort Topical Spray
Hide Arm/Group Description Topicort spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Open Label
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
53.33  (7.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
5
  25.0%
Male
15
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Psoriasis Severity
Hide Description 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%.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Topicort topical spray

Topicort Topical Spray: open label Topicort spray

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.25  (5.71)
2.Secondary Outcome
Title Psoriasis Severity
Hide Description Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Topicort topical spray

Topicort Topical Spray: open label Topicort spray

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.65  (.89)
3.Secondary Outcome
Title Psoriasis Severity
Hide Description Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Topicort topical spray

Topicort Topical Spray: open label Topicort spray

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
2.05  (2.28)
4.Secondary Outcome
Title Dermatology Life Quality Index
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Topicort topical spray

Topicort Topical Spray: open label Topicort spray

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.65  (4.08)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label
Hide Arm/Group Description

Topicort topical spray

Topicort Topical Spray: open label Topicort spray

All-Cause Mortality
Open Label
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Label
Affected / at Risk (%) # Events
Total   7/20 (35.00%)    
Cardiac disorders   
hypertension  1/20 (5.00%)  1
Infections and infestations   
cough/congestion  1/20 (5.00%)  1
Metabolism and nutrition disorders   
hyperglycemia  1/20 (5.00%)  1
Nervous system disorders   
sciatic neuralgia  1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
worsening of psoriasis  2/20 (10.00%)  2
erythema multiforme  1/20 (5.00%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jerry Bagel Director of Clinical Trials
Organization: Psoriasis Treatment Center of Central New Jersey
Phone: 6094434500
EMail: dreamacres1@aol.com
Layout table for additonal information
Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT02983981     History of Changes
Other Study ID Numbers: JB-01
First Submitted: October 5, 2016
First Posted: December 6, 2016
Results First Submitted: December 21, 2017
Results First Posted: May 7, 2018
Last Update Posted: January 14, 2019