Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Information source: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Plaque Psoriasis
Intervention: IDP-118 Lotion (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Valeant Pharmaceuticals International, Inc.
Summary
The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The percent of subjects who experience a local skin reaction graded at a level of 3 at any point in the study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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 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.
Locations and Contacts
Additional Information
Starting date: July 2015
Last updated: June 1, 2015
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