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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.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
Awards & highlights

Study 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.Check my eligibility
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).See study design
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
Select...
I have moderate to severe psoriasis, not including my face, scalp, underarms, or skin folds.
Select...
I have psoriasis covering 10% of my body, not including my face, scalp, underarms, or skin folds.
Select...
I am between 6 and 16 years old.
Select...
I have psoriasis on more than 10% of my body, not including my face, scalp, underarms, or skin folds.
Select...
I am willing to use birth control during the study.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes
Secondary outcome measures
Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Side effects data

From 2017 Phase 3 trial • 217 Patients • NCT02514577
1%
Lobar pneumonia
1%
Anal fissure
1%
Application site cellulitis
1%
Diverticulitis
1%
Cardiac failure chronic
100%
80%
60%
40%
20%
0%
Study treatment Arm
IDP-122 Vehicle Lotion
IDP-122 Lotion

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

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,983 Total Patients Enrolled
24 Trials studying Psoriasis
11,512 Patients Enrolled for Psoriasis
Anya LoncaricStudy DirectorBausch Health Americas, Inc.
39 Previous Clinical Trials
20,786 Total Patients Enrolled
4 Trials studying Psoriasis
3,813 Patients Enrolled for Psoriasis
Varsha BhattStudy DirectorBausch Health Americas, Inc.
8 Previous Clinical Trials
994 Total Patients Enrolled
2 Trials studying Psoriasis
61 Patients Enrolled for Psoriasis

Media Library

IDP-122 Lotion (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03987763 — Phase 4
Psoriasis Research Study Groups: IDP-122 Lotion
Psoriasis Clinical Trial 2023: IDP-122 Lotion Highlights & Side Effects. Trial Name: NCT03987763 — Phase 4
IDP-122 Lotion (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03987763 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Bausch Site 05
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Jun 2024