IDP-118 Lotion for Psoriasis

Recruiting at 6 trial locations

Overseen By Alison Magnotti-Nagel

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch Health Americas, Inc.

Must not be taking: Topical antipsoriatics, Corticosteroids

Disqualifiers: Adrenal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 28

Duration: 8 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a lotion called IDP-118 for children with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. Researchers seek to understand the lotion's safety and its effects on hormone levels in the body. The trial seeks children and teens ages 4 to 16 with psoriasis covering at least 10% of their body. Participants must limit sun exposure on treated skin during the study. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

You may need to stop using certain psoriasis treatments before joining the trial. Specifically, you should not have used topical psoriasis treatments other than corticosteroids within 14 days before the trial starts, and you should not have used corticosteroids within 28 days before a specific test in the trial.

What is the safety track record for IDP-118 Lotion?

Research has shown that IDP-118 Lotion is generally safe for treating plaque psoriasis. In studies with adults, participants tolerated the lotion well with daily use. Some experienced mild skin irritation, but serious side effects were rare.

The FDA has approved the lotion for adults with plaque psoriasis, indicating its safety for them. However, this study aims to determine its safety for children, as their skin may react differently. While the lotion appears promising, ongoing research will confirm its safety for younger patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The IDP-118 Lotion is unique because it combines two active ingredients, halobetasol propionate and tazarotene, in a single formulation. This dual-action approach targets psoriasis by reducing inflammation and promoting cell turnover, which is different from many current treatments that typically use one active component. Researchers are excited about this treatment because it offers the potential for effective management of psoriasis with once-daily application, potentially improving adherence and outcomes for younger patients.

What is the effectiveness track record for IDP-118 Lotion in treating psoriasis?

Research shows that IDP-118 Lotion can help treat plaque psoriasis. This lotion combines halobetasol propionate and tazarotene, which work together to reduce skin inflammation and slow the growth of skin cells. In studies with adults, this treatment significantly improved psoriasis symptoms such as redness and scaling. Specifically, patients experienced clearer skin and thinner plaques. The lotion is approved for use in adults, supporting its effectiveness. The current trial tests its safety and effectiveness in children with moderate to severe plaque psoriasis. ^{4 5 6 7 8}

Who Is on the Research Team?

Alison Magnotti-Nagel

Principal Investigator

Bausch Health Americas, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 4 and 16 years old.

Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.

I am willing to use birth control during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply IDP-118 Lotion to lesions once daily for 8 weeks

8 weeks

Daily application, with blood samples on Days 28-29

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IDP-118 Lotion

Trial Overview 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.

How Is the Trial Designed?

Group I: IDP-118 Lotion Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02785172?tab=results

Study Results | Safety and Efficacy of IDP-118 Lotion to Ultravate ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/209355Orig1s000MultidisciplineR.pdf

209355Orig1s000 - accessdata.fda.gov Generally, I will not discuss the results from the IDP-118 Lotion or Tazorac® Cream ... There are no available data on BRYHALI Lotion use in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7295208/

Impact of Halobetasol Propionate and Tazarotene Lotion ... A safety and pharmacokinetics study of IDP-118 lotion in pediatric participants with plaque psoriasis - full text view - clinicalTrials.gov.

4. trial.medpath.com trial.medpath.com/clinical-trial/3f949dcf1e589989/nct02785159-idp-118-lotion-tazarotene-cream-plaque-psoriasis

Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque ... Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-idp-118-lotion-tazarotene-and-halobetasol-propionate-for-children-with-moderate-to-severe-plaque-psoriasis/

Study on the Effects of IDP-118 Lotion (Tazarotene and ... This clinical trial is focused on studying the effects of a treatment for plaque psoriasis, a skin condition that causes red, scaly patches.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02045277

Safety and Efficacy of IDP 118 in the Treatment of Plaque ... The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02785159?term=NCT02160665%20NCT02235480%20NCT02785159%20NCT02886702%20NCT03058744%20NCT03263624%20NCT04119102%20NCT05282771%20NCT05555797%20NCT05872256&rank=8

Safety and Efficacy of IDP-118 Lotion in the Treatment ... Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. Has a ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/209354Orig1s000OtherR.pdf

Other Review(s) - accessdata.fda.gov IDP-118 Lotion is indicated for topical treatment of plaque psoriasis in patients 18 years of age and older. The clinical program included ...