NCT03058744

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

December 21, 2016

Last Update Submit

June 8, 2017

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Local Skin Reactions (LSRs)

    Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.

    8 Weeks

Study Arms (4)

IDP-118 Lotion

EXPERIMENTAL

8 Weeks

Drug: IDP-118 Lotion

HP Monad Lotion

EXPERIMENTAL

8 Weeks

Drug: HP Monad Lotion

Ultravate Cream

ACTIVE COMPARATOR

2 Weeks

Drug: Ultravate Cream

Tazorac Cream

ACTIVE COMPARATOR

4 Weeks

Drug: Tazorac Cream

Interventions

IDP-118 LotionDRUG

Lotion

Also known as: Lotion
IDP-118 Lotion
HP Monad LotionDRUG

Lotion

Also known as: Lotion
HP Monad Lotion
Ultravate CreamDRUG

Cream

Also known as: Ultravate
Ultravate Cream
Tazorac CreamDRUG

Cream

Also known as: Taz
Tazorac Cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Valeant Site 12

Anaheim, California, 92801, United States

Location

Valeant Site 05

Encino, California, 91436, United States

Location

Valeant Site 01

San Diego, California, 92093, United States

Location

Valeant Site 07

Santa Rosa, California, 95401, United States

Location

Valeant Site 10

Orange Park, Florida, 32065, United States

Location

Valeant Site 09

Sanford, Florida, 32771, United States

Location

Valeant Site 08

Atlanta, Georgia, 30301, United States

Location

Valeant Site 04

Plainfield, Indiana, 46168, United States

Location

Valeant Site 06

New York, New York, 10001, United States

Location

Valeant Site 11

Philadelphia, Pennsylvania, 19019, United States

Location

Valeant Site 03

Austin, Texas, 73301, United States

Location

Valeant Site 02

Katy, Texas, 77449, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

halobetasolTranscriptional Coactivator with PDZ-Binding Motif Proteins

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Adaptor Proteins, Signal TransducingIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsCarrier ProteinsProteins

Study Officials

  • Lindsey Mathew

    Valeant Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

February 23, 2017

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations

US(12)