Clinical trial NCT03058744: Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Official title: A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Detailed description: A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Eligibility criteria: Inclusion Criteria:

* Male or Female of any race, at least 18 years old of age (inclusive)
* Freely provides both written and oral informed consent.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
* Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
* The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.

Key Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
* Has a history of adrenal disease.
* Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing, or planning pregnancy during the study period.

Primary outcomes:
measure: Local Skin Reactions (LSRs)
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Valeant Site 12
state: California
city: Encino
country: United States
facility: Valeant Site 05
state: California
city: San Diego
country: United States
facility: Valeant Site 01
state: California
city: Santa Rosa
country: United States
facility: Valeant Site 07
state: California
city: Orange Park
country: United States
facility: Valeant Site 10
state: Florida
city: Sanford
country: United States
facility: Valeant Site 09
state: Florida
city: Atlanta
country: United States
facility: Valeant Site 08
state: Georgia
city: Plainfield
country: United States
facility: Valeant Site 04
state: Indiana
city: New York
country: United States
facility: Valeant Site 06
state: New York
city: Philadelphia
country: United States
facility: Valeant Site 11
state: Pennsylvania
city: Austin
country: United States
facility: Valeant Site 03
state: Texas
city: Katy
country: United States
facility: Valeant Site 02
state: Texas
Study officials:
affiliation: Valeant Pharmaceuticals
name: Lindsey Mathew
role: STUDY_DIRECTOR
References: