Safety and Efficacy 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: | 12/17/2017 |
Start Date: | February 2016 |
End Date: | December 2016 |
A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
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 (IGA) Investigator
Global Assessment score of 3 or 4. (The face, scalp, palms, soles, axillae and
intertriginous areas are to be excluded in this assessment, if psoriasis is present.)
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
13
sites
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