Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
This study has been completed.
Sponsor:
Valeant Pharmaceuticals International, Inc.
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT02462083
First received: June 1, 2015
Last updated: April 26, 2017
Last verified: April 2017
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Purpose
The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.
| Condition | Intervention | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: IDP-118 Lotion | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking 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 |
Resource links provided by NLM:
Further study details as provided by Valeant Pharmaceuticals International, Inc.:
Primary Outcome Measures:
- 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
| Enrollment: | 555 |
| Actual Study Start Date: | August 11, 2015 |
| Study Completion Date: | April 24, 2017 |
| Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IDP-118 Lotion
halobetasol propionate [HP], tazarotene [Taz]
|
Drug: IDP-118 Lotion
Applied topically once daily
Other Names:
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02462083
Show 46 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02462083
Show 46 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Dow Pharmaceutical Sciences
Investigators
| Study Director: | Binu J Alexander, MD | Valeant Pharmaceuticals |
More Information
| Responsible Party: | Valeant Pharmaceuticals International, Inc. |
| ClinicalTrials.gov Identifier: | NCT02462083 History of Changes |
| Obsolete Identifiers: | NCT02611349 |
| Other Study ID Numbers: |
V01-118A-303 |
| Study First Received: | June 1, 2015 |
| Last Updated: | April 26, 2017 |
| 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 |
ClinicalTrials.gov processed this record on July 17, 2017


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