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Corticosteroid

IDP-122 Lotion for Psoriasis

Phase 4

Recruiting

Research Sponsored by Bausch Health Americas, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Is 6 to 16 years 11 months of age at time of informed consent/assent obtained.

Must not have

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.

Has a history of adrenal disease.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing a new medication for plaque psoriasis in children. The goal is to see if it's safe and effective, with minimal side effects.

Who is the study for?

This trial is for children aged 6 to nearly 17 with moderate to severe plaque psoriasis covering at least 10% of their body, excluding face, scalp, and certain other areas. Participants must avoid excessive UV light exposure and girls able to have children must use birth control. Those with adrenal diseases or allergies to the lotion's ingredients can't join.

What is being tested?

The study tests IDP-122 Lotion's safety in kids with psoriasis, focusing on how much drug gets into the bloodstream and if it affects adrenal gland function (which controls stress response).

What are the potential side effects?

Possible side effects may include skin irritation at the application site, hormonal imbalances affecting growth or weight gain due to systemic absorption of halobetasol propionate (the active ingredient), or worsening of psoriasis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe psoriasis, not including my face, scalp, underarms, or skin folds.

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I am between 6 and 16 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't used any experimental drugs or devices recently.

Select...

I have a history of adrenal gland problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes

Secondary study objectives

Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Side effects data

From 2017 Phase 3 trial • 217 Patients • NCT02514577

Lobar pneumonia

Anal fissure

Application site cellulitis

Diverticulitis

Cardiac failure chronic

100%

80%

60%

40%

20%

Study treatment Arm

IDP-122 Vehicle Lotion

IDP-122 Lotion

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IDP-122 LotionExperimental Treatment1 Intervention

Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 6 to 11 years 11 months) will apply IDP-122 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IDP-122 Lotion

2015

Completed Phase 3

~580

0 / 4Eligibility criteria met