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Long-Term Safety of IDP-118 Lotion in the Treatment of 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: NCT02462083
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
The objective of this study is to evaluate the long-term safety of IDP-118 lotion.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: IDP-118 Lotion Phase 3

Detailed Description:
This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female, of any race, at least 18 years of age (inclusive).
  • Freely provides both verbal and written informed consent.
  • Has an area of plaque psoriasis appropriate for topical treatment that covers a Body Surface Area (BSA) of at least 3 percent (%), but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
  • Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
  • Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigators Global Assessment (IGA) score of 3 or 4 (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Key Exclusion Criteria:

  • Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
  • Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
  • Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
  • Is pregnant, nursing an infant, or planning a pregnancy during the study period.
  • Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.

Information from the National Library of Medicine

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


Locations
Show Show 46 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Dow Pharmaceutical Sciences
Investigators
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Study Director: Binu J Alexander Valeant Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Bausch Health Americas, Inc.:
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02462083    
Obsolete Identifiers: NCT02611349
Other Study ID Numbers: V01-118A-303
First Posted: June 3, 2015    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases