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Trial record 2 of 8 for:    IDP 118

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
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, 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 subjects with plaque psoriasis. To be eligible for the study, subjects must be at least 18 years of age and have a clinical diagnosis of moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
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 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
halobetasol propionate [HP], tazarotene [Taz]
Drug: IDP-118 Lotion
Applied topically once daily
Other Names:
  • Tazarotene
  • halobetasol propionate




Primary Outcome Measures :
  1. The percent of subjects who experience a local skin reaction [ Time Frame: up to 12 months ]
    Graded at a level of 3 (on the Investigators Global Assessment [IGA] scale) at any point in the study



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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%, 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


  Show 46 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Dow Pharmaceutical Sciences
Investigators
Study Director: Binu J Alexander, MD Valeant Pharmaceuticals

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT02462083     History of Changes
Obsolete Identifiers: NCT02611349
Other Study ID Numbers: V01-118A-303
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tazarotene
Halobetasol
Dermatologic Agents
Keratolytic Agents
Vasoconstrictor Agents