What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for psoriasis, such as topical corticosteroids and retinoids, can have several side effects. Topical corticosteroids may cause skin thinning, stretch marks, and increased susceptibility to skin infections. Retinoids, like tazarotene, can lead to skin irritation, dryness, and increased sensitivity to sunlight. Systemic treatments, including biologics and oral medications, may have more severe side effects, such as increased risk of infections, liver toxicity, and potential cardiovascular issues. It's important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for psoriasis, including topical corticosteroids and retinoids, which are known for their anti-inflammatory and keratolytic effects. Topical corticosteroids, such as clobetasol and betamethasone, are commonly used to reduce inflammation and plaque formation. Retinoids like tazarotene are also approved for their ability to normalize skin cell growth. Combination therapies, such as those involving both corticosteroids and retinoids, have been developed to enhance efficacy and reduce side effects. Additionally, biologics targeting specific immune pathways and systemic treatments like methotrexate and cyclosporine are also FDA-approved for more severe cases of psoriasis.

What other types of research exist?

Promising novel alternatives to IDP-118 lotion for psoriasis patients include: 1) Topical Janus kinase (JAK) inhibitors, which target specific pathways involved in inflammation. 2) Phosphodiesterase-4 (PDE4) inhibitors, which reduce inflammation by modulating cyclic AMP levels. 3) New formulations of existing drugs, such as liposomal encapsulated drugs, which may enhance delivery and reduce side effects. These emerging treatments are currently being evaluated in clinical trials and may offer improved outcomes for psoriasis patients.

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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 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 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, 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

0 / 7Eligibility criteria met

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.