Trial Outcomes & Findings for Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis (NCT NCT02462083)
NCT ID: NCT02462083
Last Updated: 2020-01-27
Results Overview
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
555 participants
Primary outcome timeframe
Baseline up to Week 52
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
IDP-18 Lotion
IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
|
|---|---|
|
Overall Study
STARTED
|
555
|
|
Overall Study
Safety Population
|
550
|
|
Overall Study
COMPLETED
|
136
|
|
Overall Study
NOT COMPLETED
|
419
|
Reasons for withdrawal
| Measure |
IDP-18 Lotion
IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
|
|---|---|
|
Overall Study
Sponsor request
|
39
|
|
Overall Study
Withdrawal by Subject
|
87
|
|
Overall Study
Lost to Follow-up
|
41
|
|
Overall Study
Lack of Efficacy
|
151
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Adverse Event
|
33
|
|
Overall Study
Worsening condition
|
16
|
|
Overall Study
Other than specified
|
45
|
Baseline Characteristics
Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
IDP-118 Lotion
n=550 Participants
IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
|
|---|---|
|
Age, Continuous
|
51.9 Years
STANDARD_DEVIATION 14.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
361 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
409 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
473 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
IDP-118 Lotion
n=550 Participants
IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
|
|---|---|
|
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Itching
|
22.2 percentage of participants
|
|
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Dryness
|
6.9 percentage of participants
|
|
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Burning/stinging
|
9.8 percentage of participants
|
Adverse Events
IDP-118 Lotion
Serious events: 18 serious events
Other events: 131 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDP-118 Lotion
n=550 participants at risk
IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
|
|---|---|
|
Infections and infestations
Cellulitis gangrenous
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Diverticulitis
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Sepsis
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Tonsillitis
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Pericardial effusion
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.18%
1/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
IDP-118 Lotion
n=550 participants at risk
IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
|
|---|---|
|
General disorders
Application site dermatitis
|
10.7%
59/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Application site pruritus
|
6.0%
33/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Application site pain
|
5.3%
29/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
28/550 • Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
|
Additional Information
Director of Clinical Operations
Bausch Health Americas, Inc.
Phone: 1-510-259-5284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER