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Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

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: NCT02514577
Recruitment Status : Completed
First Posted : August 3, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: IDP-122 Lotion
Drug: IDP-122 Vehicle Lotion
Enrollment 217
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IDP-122 Lotion IDP-122 Vehicle Lotion
Hide Arm/Group Description Participants applied IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks. Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Period Title: Overall Study
Started 143 74
Intent-to-Treat (ITT) Population [1] 143 74
Safety Population [2] 142 72
Completed 129 61
Not Completed 14 13
Reason Not Completed
Lost to Follow-up             6             6
Protocol Violation             1             0
Withdrawal by Subject             6             6
Adverse Event             1             1
[1]
Participants who were randomized and dispensed study drug.
[2]
Randomized participants with ≥1 confirmed dose of study drug and ≥1 post-Baseline safety assessment.
Arm/Group Title IDP-122 Lotion IDP-122 Vehicle Lotion Total
Hide Arm/Group Description Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks. Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 143 74 217
Hide Baseline Analysis Population Description
Participants who were randomized and dispensed study drug (ITT population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 143 participants 74 participants 217 participants
51.6  (14.84) 51.0  (15.43) 51.4  (15.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 74 participants 217 participants
Female
58
  40.6%
35
  47.3%
93
  42.9%
Male
85
  59.4%
39
  52.7%
124
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 74 participants 217 participants
Hispanic or Latino
41
  28.7%
20
  27.0%
61
  28.1%
Not Hispanic or Latino
102
  71.3%
54
  73.0%
156
  71.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 143 participants 74 participants 217 participants
Asian 5 2 7
Black or African American 13 3 16
Native Hawaiian or Other Pacific Islander 2 1 3
White 121 68 189
Turkish 1 0 1
Unknown 1 0 1
Investigator's Global Assessment [IGA] Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 143 participants 74 participants 217 participants
0 - Clear 0 0 0
1 - Almost Clear 0 0 0
2 - Mild 0 0 0
3 - Moderate 121 61 182
4 - Severe 22 13 35
[1]
Measure Description: The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
1.Primary Outcome
Title Percentage of Participants With Treatment Success at Week 8
Hide Description Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and dispensed study drug (ITT population). Markov Chain Monte Carlo (MCMC) multiple imputation was used to impute missing data.
Arm/Group Title IDP-122 Lotion IDP-122 Vehicle Lotion
Hide Arm/Group Description:
Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Overall Number of Participants Analyzed 143 74
Measure Type: Number
Unit of Measure: percentage of participants
36.5 8.13
2.Secondary Outcome
Title Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Hide Description Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time Frame Weeks 2, 4, 6, and 12 (4-week follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and dispensed study drug (ITT population). MCMC multiple imputation was used to impute missing data.
Arm/Group Title IDP-122 Lotion IDP-122 Vehicle Lotion
Hide Arm/Group Description:
Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Overall Number of Participants Analyzed 143 74
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 7.06 0
Week 4 19.81 2.77
Week 6 30.14 7.93
Week 12 19.48 6.69
Time Frame Baseline through Week 12
Adverse Event Reporting Description Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
 
Arm/Group Title IDP-122 Lotion IDP-122 Vehicle Lotion
Hide Arm/Group Description Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks. Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
All-Cause Mortality
IDP-122 Lotion IDP-122 Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/142 (0.00%)   0/72 (0.00%) 
Hide Serious Adverse Events
IDP-122 Lotion IDP-122 Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   1/142 (0.70%)   3/72 (4.17%) 
Cardiac disorders     
Cardiac failure chronic  1  1/142 (0.70%)  1/72 (1.39%) 
Gastrointestinal disorders     
Anal fissure  1  0/142 (0.00%)  1/72 (1.39%) 
Infections and infestations     
Lobar pneumonia  1  0/142 (0.00%)  1/72 (1.39%) 
Application site cellulitis  1  0/142 (0.00%)  1/72 (1.39%) 
Diverticulitis  1  0/142 (0.00%)  1/72 (1.39%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IDP-122 Lotion IDP-122 Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/142 (0.00%)   0/72 (0.00%) 
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.
Please contact Sponsor directly for additional information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Operations
Organization: Bausch Health Americas, Inc.
Phone: 1-510-259-5284
EMail: aloncaric@bauschhealth.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02514577    
Other Study ID Numbers: V01-122A-301
First Submitted: July 31, 2015
First Posted: August 3, 2015
Results First Submitted: January 14, 2020
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020