Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2018 |
Start Date: | August 11, 2015 |
End Date: | April 24, 2017 |
A Phase 3, Multicenter, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.
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).
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).
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.
We found this trial at
41
sites
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