NCT03988439

Brief Summary

This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4

Geographic Reach
3 countries

9 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

June 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 24, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

June 13, 2019

Last Update Submit

April 6, 2026

Conditions

Psoriasis

Keywords

Plaque psoriasis

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics: : Maximum Observed Drug (Halobetasol Propionate, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes

    On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-118 lotion analytes.

    0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose

Secondary Outcomes (1)

  • Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8

    Week 8

Study Arms (1)

IDP-118 Lotion

EXPERIMENTAL

Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 4 to 11 years 11 months) will apply IDP-118 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.

Drug: IDP-118 Lotion

Interventions

IDP-118 LotionDRUG

Topical

IDP-118 Lotion

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Is 4 to 16 years 11 months of age at time of informed consent/assent obtained.
  • Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.
  • Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.
  • Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, 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.
  • Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is \>18 μg/dL at the Screening visit.
  • Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.

You may not qualify if:

  • Has a history of adrenal disease.
  • 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 baseline or is concurrently participating in another clinical study with an investigational drug or device.
  • Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.
  • Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
  • Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Bausch Site 7

Doral, Florida, 33166, United States

Location

Bausch Site 11

Miami, Florida, 33173, United States

Location

Bausch Site 3

Louisville, Kentucky, 40217, United States

Location

Bausch Site 6

Saint Joseph, Missouri, 64506, United States

Location

Bausch Site 1

Henderson, Nevada, 89052, United States

Location

Bausch Site 5

San Antonio, Texas, 78213, United States

Location

Bausch Site 4

Murray, Utah, 84123, United States

Location

Bausch Site 12

Santo Domingo, Dominican Republic

Location

Bausch Site 2

Panama City, Panama

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alison Magnotti-Nagel

    Bausch Health Americas, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 17, 2019

Study Start

March 24, 2021

Primary Completion

February 6, 2026

Study Completion

February 6, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(7)DO(1)PA(1)