Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882647
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: 000-0551 Lotion
Drug: Vehicle Lotion
Enrollment 222
Recruitment Details

Recruitment period: June 2013 to February 2014

The location of clinical sites included dermatology clinics and clinical research centers.

Pre-assignment Details All subjects who met the entry criteria were randomized and enrolled into the study.
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Period Title: Overall Study
Started 110 112
Completed 108 106
Not Completed 2 6
Reason Not Completed
Lost to Follow-up             2             2
Withdrawal by Subject             0             4
Arm/Group Title Active Arm Vehicle Arm Total
Hide Arm/Group Description

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Total of all reporting groups
Overall Number of Baseline Participants 110 112 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean Number Analyzed 110 participants 112 participants 222 participants
50.8  (14.49) 50.8  (15.15) 50.8  (14.79)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 222 participants
Female
50
  45.5%
60
  53.6%
110
  49.5%
Male
60
  54.5%
52
  46.4%
112
  50.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 222 participants
Hispanic or Latino
19
  17.3%
21
  18.8%
40
  18.0%
Not Hispanic or Latino
91
  82.7%
91
  81.3%
182
  82.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 222 participants
American Indian or Alaska Native
0
   0.0%
1
   0.9%
1
   0.5%
Asian
4
   3.6%
0
   0.0%
4
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   3.6%
9
   8.0%
13
   5.9%
White
102
  92.7%
102
  91.1%
204
  91.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Hide Description The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were classified into the following datasets: intent-to-treat (ITT), per protocol (PP), and safety populations. Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description:

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Overall Number of Participants Analyzed 110 112
Measure Type: Number
Unit of Measure: percentage of participants
44.5 7.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Arm, Vehicle Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment groups were compared with respect to the proportions of subjects with "treatment success" at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center.
Method Cochran-Mantel-Haenszel
Comments Multiple imputation was used to impute missing data from the ITT population.
2.Secondary Outcome
Title The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Hide Description A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description:

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Overall Number of Participants Analyzed 110 112
Measure Type: Number
Unit of Measure: percentage of participants
Scaling 59.1 9.8
Erythema 43.6 10.7
Plaque Elevation 43.6 8.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Arm, Vehicle Arm
Comments Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The pre-specified threshold for statistical significance was ≤0.05.
Method Cochran-Mantel-Haenszel
Comments Missing data was imputed as treatment failure.
3.Other Pre-specified Outcome
Title Percentage of Subjects With IGA "Treatment Success" at Day 8
Hide Description Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description:

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: percentage of participants
12.1 2.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Arm, Vehicle Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8
Hide Description Interim analysis of clinical signs of psoriasis. "Treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description:

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: percentage of participants
Scaling 36.4 6.5
Erythema 13.1 3.7
Plaque Elevation 17.8 3.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Arm, Vehicle Arm
Comments Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The pre-specified threshold for statistical significance was ≤0.05.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Change From Baseline in Pruritus Score at Day 15
Hide Description Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description:

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Overall Number of Participants Analyzed 108 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.6  (3.65) -1.9  (3.24)
6.Other Pre-specified Outcome
Title Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15
Hide Description The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the Intent-to-Treat (ITT) population at Day 15 and compared to baseline. ITT was defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description:

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

Overall Number of Participants Analyzed 108 106
Mean (Standard Deviation)
Unit of Measure: Change in %BSA
-2.4  (2.68) -0.3  (1.12)
Time Frame Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
Adverse Event Reporting Description The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
 
Arm/Group Title Active Arm Vehicle Arm
Hide Arm/Group Description

Topical lotion, applied twice daily

000-0551 Lotion

Topical lotion, applied twice daily

Vehicle Lotion

All-Cause Mortality
Active Arm Vehicle Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Active Arm Vehicle Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/110 (0.91%)      0/112 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease with Acute Exacerbation * 1 [1]  1/110 (0.91%)  1 0/112 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 16.0
[1]
The event was determined to be unrelated to the test article.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Arm Vehicle Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/110 (9.09%)      5/112 (4.46%)    
Gastrointestinal disorders     
Bowel movement irregularity * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Diarrhoea * 1  2/110 (1.82%)  2 0/112 (0.00%)  0
Dry Mouth * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Food poisoning * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Nausea * 1  1/110 (0.91%)  1 1/112 (0.89%)  1
General disorders     
Application site atrophy * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Application site pain * 1  2/110 (1.82%)  2 1/112 (0.89%)  1
Application site telangiectasia * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Chest discomfort * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Infections and infestations     
Otitis media acute * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Upper respiratory tract infection * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Injury, poisoning and procedural complications     
Wound * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Investigations     
Intraocular pressure increased * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle spasms * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Myalgia * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Nervous system disorders     
Headache * 1  2/110 (1.82%)  2 1/112 (0.89%)  1
Psychiatric disorders     
Insomnia * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
Dyspnoea * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Skin and subcutaneous tissue disorders     
Nail bed disorder * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Pruritus * 1  0/110 (0.00%)  0 1/112 (0.89%)  1
Rash erythematous * 1  1/110 (0.91%)  1 0/112 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review thirty days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research, Therapeutics Inc.
Organization: Therapeutics, Inc.
Phone: 585-571-1800
EMail: clinicalreseach@therapeuticsinc.com
Layout table for additonal information
Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01882647    
Other Study ID Numbers: 000-0551-305
First Submitted: June 18, 2013
First Posted: June 20, 2013
Results First Submitted: March 10, 2016
Results First Posted: February 13, 2017
Last Update Posted: February 13, 2017