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Topical Medication

IDP-118 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
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.
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 will test a topical treatment for plaque psoriasis to see if it is safe and effective, with the potential to suppress the body's HPA axis.

Who is the study for?
This trial is for children aged 4 to nearly 17 with moderate to severe plaque psoriasis, covering at least 10% of their body excluding face, scalp, and certain areas. They must have normal adrenal function and agree to avoid sun/UV exposure. Girls able to have children must use birth control during the study.Check my eligibility
What is being tested?
The trial tests IDP-118 Lotion's safety and effects on the body when applied topically in kids with plaque psoriasis. It also checks if it affects adrenal gland hormones by measuring cortisol levels after a stimulation test.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include skin reactions at the application site or systemic effects due to absorption through the skin which could influence hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 4 and 16 years old.
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, excluding my face, scalp, and certain areas.
Select...
I can stay out of the sun and away from UV lights during the study.
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, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes
Secondary outcome measures
Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8

Side effects data

From 2016 Phase 3 trial • 203 Patients • NCT02462070
5%
Dermatitis contact
1%
Cellulitis staphylococcal
1%
Pneumonia
1%
Asthma
1%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IDP-118 Lotion
IDP-118 Vehicle Lotion

Trial Design

1Treatment groups
Experimental Treatment
Group I: IDP-118 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 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IDP-118 Lotion
2016
Completed Phase 3
~1590

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-118 Lotion (Topical Medication) Clinical Trial Eligibility Overview. Trial Name: NCT03988439 — Phase 4
Psoriasis Research Study Groups: IDP-118 Lotion
Psoriasis Clinical Trial 2023: IDP-118 Lotion Highlights & Side Effects. Trial Name: NCT03988439 — Phase 4
IDP-118 Lotion (Topical Medication) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03988439 — Phase 4
Psoriasis Patient Testimony for trial: Trial Name: NCT03988439 — Phase 4

Frequently Asked Questions

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

Are there presently opportunities for individuals to participate in this study?

"Affirmative. According to clinicaltrials.gov, this medical experiment is currently enrolling participants and was first advertised on March 24th 2021. 45 volunteers are required from 6 different healthcare facilities with the most recent update being posted June 6th 2022."

Answered by AI

Has the FDA approved IDP-118 Lotion for therapeutic use?

"As this is a Phase 4 trial and the drug has already been approved, we have judged IDP-118 Lotion to be of high safety with a score of 3."

Answered by AI

Are there any facilities within this city that are currently conducting the clinical trial?

"This study is recruiting patients from 6 different centres located in cities like Miami, Louisville and Murray. If you choose to participate, it would be wise to select the clinical trial site closest to your residence in order to reduce travel requirements."

Answered by AI

Are any participants over 20 years of age currently enrolled in the clinical trial?

"According to the eligibility requirements, this clinical trial is intended for participants aged 4-17. In comparison, 31 trials are open for those below 18 and 142 have been designed with patients over 65 in mind."

Answered by AI

How many people can potentially be recruited for this research project?

"Yes, records on clinicaltrials.gov demonstrate that this trial is currently accepting patients. The research was first posted in March 2021 and has been modified as recently June 6th 2022 with the goal of recruiting 45 individuals from six distinct sites."

Answered by AI

To whom is this scientific inquiry open?

"This clinical trial is recruiting 45 paediatric patients aged between 4 and 17 who have been clinically diagnosed with psoriasis. To be considered, they must also possess a plaque covering at least 10% body surface area (excluding face, scalp, axillae and intertriginous areas) as well as an Investigator's Global Assessment score of 3 or 4 when assessed by a doctor. Moreover, females within the age group above 9 years old must practice effective contraception for the duration of the study while all participants are expected to avoid prolonged exposure to ultraviolet radiation from natural and artificial sources throughout their involvement in this experiment."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
18 - 65
What site did they apply to?
Bausch Site 2
Bausch Site 3
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I would love for the street of my psoriasis not to bother me. I am tired of wasting money on things that don't work for my psoriasis.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Bausch Site 3: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis
2021. "A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03988439.
All > Psoriasis > Plaque Psoriasis
~1 spots leftby Jun 2024
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