NCT02045277

Brief Summary

The objective of the study is to evaluate the safety and efficacy of a topical lotion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

18 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

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

August 20, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

January 22, 2014

Results QC Date

August 8, 2020

Last Update Submit

August 8, 2020

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8

    Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).

    8 weeks

  • Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12

    Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).

    Weeks 2, 4, 6, and 12 (4-week follow-up)

Study Arms (4)

IDP-118 Lotion

EXPERIMENTAL

halobetasol propionate \[HP\], tazarotene \[Taz\]

Drug: IDP-118 Lotion

IDP-118 Monad HP Lotion

ACTIVE COMPARATOR

HP

Drug: IDP-118 Monad HP Lotion

IDP-118 Monad Taz Lotion

ACTIVE COMPARATOR

Taz

Drug: IDP-118 Monad Taz Lotion

IDP-118 Vehicle Lotion

ACTIVE COMPARATOR

Vehicle

Drug: IDP-118 Vehicle Lotion

Interventions

IDP-118 LotionDRUG

Lotion

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

Active Comparator

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

Active Comparator

Also known as: Taz
IDP-118 Monad Taz Lotion
IDP-118 Vehicle LotionDRUG

Vehicle

Also known as: Vehicle
IDP-118 Vehicle Lotion

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 of age (inclusive).
  • Freely provides both verbal and written informed consent.
  • Has an area of plaque psoriasis appropriate for topical treatment that covers a 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 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Valeant Site 13

Encino, California, 91436, United States

Location

Valeant Site 11

San Diego, California, 92123, United States

Location

Valeant Site 15

Santa Rosa, California, 95403, United States

Location

Valeant Site 10

Augusta, Georgia, 30909, United States

Location

Valeant Site 09

Newnan, Georgia, 30263, United States

Location

Valeant Site 08

Louisville, Kentucky, 40217, United States

Location

Valeant Site 04

Rockville, Maryland, 20850, United States

Location

Valeant Site 14

Clinton Township, Michigan, 48038, United States

Location

Valeant Site 07

Fridley, Minnesota, 55432, United States

Location

Valeant Site 01

East Windsor, New Jersey, 08520, United States

Location

Valeant Site 03

New York, New York, 10075, United States

Location

Valeant Site 17

Rochester, New York, 14623, United States

Location

Valeant Site 02

High Point, North Carolina, 27262, United States

Location

Valeant Site 05

Austin, Texas, 78759, United States

Location

Valeant Site 06

College Station, Texas, 77845, United States

Location

Valeant Site 16

Salt Lake City, Utah, 84117, United States

Location

Valeant Site 18

Lynchburg, Virginia, 24501, United States

Location

Valeant Site 12

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Transcriptional Coactivator with PDZ-Binding Motif Proteins

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Study Director
Organization
Bausch Health
anya.loncaric@bauschhealth.com

Study Officials

  • Binu J Alexander

    Valeant Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 20, 2020

Results First Posted

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Locations

US(18)