A Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Status: | Recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2015 |
End Date: | December 2016 |
Contact: | Krista Bohnert |
Email: | kbohnert@sadickdermatology.com |
Phone: | 2127727242 |
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
This is a double-blind study to evaluate the safety and efficacy of topical IDP-118 Lotion
when applied once daily to adult subjects with moderate to severe plaque psoriasis.
when applied once daily to adult subjects with moderate to severe plaque psoriasis.
Patients will be randomized in a 2:1 ratio to receive IDP-118 Lotion and IDP-118 Vehicle
Lotion.
Lotion.
Inclusion Criteria:
- Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA
of at lease 3%, but no more than 12%
- is willing to avoid prolonged exposure of the treatment area to ultraviolet radiation
(natural and artificial) for the duration of the study
- is in overall good general health
- if female, is not pregnant, planning to become pregnant or breastfeeding.
Exclusion Criteria:
- has received treatment with a biologic within the past 3 months
- is currently using lithium or Plaquenil
- has a history of drug or alcohol abuse
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