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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a special lotion called IDP-118 for children with moderate to severe plaque psoriasis. It aims to ensure the lotion is safe, see how much gets into the body, and check if it affects stress-related hormones. The goal is to find a safe and effective treatment for these children. IDP-118 is a combination of halobetasol propionate and tazarotene, which has shown effectiveness in treating moderate-to-severe plaque psoriasis in adults.
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.
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.
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 belowSelect...
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 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
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, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes
Secondary study objectives
Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8
Awards & Highlights
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Topical corticosteroids and retinoids are common treatments for psoriasis, working through anti-inflammatory and keratolytic mechanisms, respectively. Corticosteroids reduce inflammation and immune response, alleviating redness, swelling, and itching.
Retinoids normalize skin cell growth and differentiation, reducing scales and plaques. Combining these treatments, as in the IDP-118 lotion, targets multiple disease pathways, offering a more effective and comprehensive symptom management for psoriasis patients.
Investigation of anti-inflammatory and anti-proliferative activities promoted by photoactivated cationic porphyrin.
Investigation of anti-inflammatory and anti-proliferative activities promoted by photoactivated cationic porphyrin.
Find a Location
Who is running the clinical trial?
Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,991 Total Patients Enrolled
24 Trials studying Psoriasis
11,512 Patients Enrolled for Psoriasis
Anya LoncaricStudy DirectorBausch Health Americas, Inc.
39 Previous Clinical Trials
20,618 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 4 and 16 years old.I am willing to use birth control during the study.I have moderate to severe psoriasis, not including my face, scalp, underarms, or skin folds.I can stay out of the sun and away from UV lights during the study.I have psoriasis covering 10% of my body, excluding my face, scalp, and certain areas.
Research Study Groups:
This trial has the following groups:- Group 1: IDP-118 Lotion
Awards:
This trial has 3 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Psoriasis Patient Testimony for trial: Trial Name: NCT03988439 — Phase 4
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