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Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02462122
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
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-118 Lotion
Drug: IDP-118 Vehicle Lotion
Enrollment 215
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IDP-118 Lotion IDP-118 Vehicle Lotion
Hide Arm/Group Description

Lotion

IDP-118 Lotion: Lotion

Vehicle Lotion

IDP-118 Vehicle Lotion: Lotion

Period Title: Overall Study
Started 141 74
Completed 120 61
Not Completed 21 13
Arm/Group Title IDP-118 Lotion IDP-118 Vehicle Lotion Total
Hide Arm/Group Description

Lotion

IDP-118 Lotion: Lotion

Vehicle Lotion

IDP-118 Vehicle Lotion: Lotion

Total of all reporting groups
Overall Number of Baseline Participants 141 74 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 74 participants 215 participants
51.8  (14.84) 51.8  (13.18) 51.8  (14.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 74 participants 215 participants
Female
55
  39.0%
24
  32.4%
79
  36.7%
Male
86
  61.0%
50
  67.6%
136
  63.3%
1.Primary Outcome
Title The Percentage of Participants With Treatment Success at Week 8
Hide Description Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-118 Lotion IDP-118 Vehicle Lotion
Hide Arm/Group Description:

Lotion

IDP-118 Lotion: Lotion

Vehicle Lotion

IDP-118 Vehicle Lotion: Lotion

Overall Number of Participants Analyzed 141 74
Measure Type: Number
Unit of Measure: percentage of participants
45.33 12.51
2.Secondary Outcome
Title Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
Hide Description Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IDP-118 Lotion IDP-118 Vehicle Lotion
Hide Arm/Group Description:

Lotion

IDP-118 Lotion: Lotion

Vehicle Lotion

IDP-118 Vehicle Lotion: Lotion

Overall Number of Participants Analyzed 141 74
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 33.35 8.84
Week 6 37.53 8.24
Week 4 26.96 1.36
Week 2 9.77 0
Time Frame 12 weeks
Adverse Event Reporting Description Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
 
Arm/Group Title IDP-118 Lotion IDP-118 Vehicle Lotion
Hide Arm/Group Description

Lotion

IDP-118 Lotion: Lotion

Vehicle Lotion

IDP-118 Vehicle Lotion: Lotion

All-Cause Mortality
IDP-118 Lotion IDP-118 Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
IDP-118 Lotion IDP-118 Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/137 (0.00%)   0/73 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IDP-118 Lotion IDP-118 Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   13/137 (9.49%)   4/73 (5.48%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact * 1  13/137 (9.49%)  0/73 (0.00%) 
Pruritis * 1  4/137 (2.92%)  4/73 (5.48%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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.
Contact sponsor directly for details.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Bausch Health
EMail: anyaloncaric@bauschhealth.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02462122    
Obsolete Identifiers: NCT02615093
Other Study ID Numbers: V01-118A-302
First Submitted: June 1, 2015
First Posted: June 3, 2015
Results First Submitted: August 8, 2020
Results First Posted: August 20, 2020
Last Update Posted: August 20, 2020