Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT02462083|
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: IDP-118 Lotion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||555 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis|
|Actual Study Start Date :||August 11, 2015|
|Actual Primary Completion Date :||January 31, 2017|
|Actual Study Completion Date :||April 24, 2017|
Experimental: IDP-118 Lotion
IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
Drug: IDP-118 Lotion
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
- Percentage of Participants Who Experienced Grade 3 Local Skin Reactions [ Time Frame: Baseline up to Week 52 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462083
|Study Director:||Binu J Alexander||Valeant Pharmaceuticals|