IDP-122 Lotion for Psoriasis

Recruiting at 3 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: Unknown

Duration: 8 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a lotion called IDP-122 to determine its safety and effectiveness for children with moderate to severe plaque psoriasis, a skin condition that causes itchy, scaly patches. Researchers aim to assess whether the lotion affects the body's hormone system and how much is absorbed into the bloodstream. Children aged 6 to 16 with psoriasis covering at least 10% of their body, excluding the face or scalp, may qualify for this study. Participants will apply the lotion daily for 8 weeks. As a Phase 4 trial, this study involves an FDA-approved treatment, helping to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical psoriasis treatments other than corticosteroids 14 days before starting, and any treatments with corticosteroids 28 days before the screening test. Other medications are not specifically mentioned, so it's best to discuss with the study team.

What is the safety track record for IDP-122 Lotion?

Research has shown that IDP-122 Lotion is generally safe to use. In past studies, both adults and children with moderate to severe plaque psoriasis used this lotion and experienced few side effects. These studies included enough participants to assess potential risks.

Reports indicate that IDP-122 Lotion, which contains the steroid halobetasol propionate, is well-tolerated when used once daily. Some individuals experienced mild skin reactions, such as redness or itching, but these were uncommon. Importantly, the FDA has already approved the lotion for treating psoriasis, confirming it has passed strict safety checks.

In summary, current data suggests the lotion is safe, with only minor side effects observed in some users. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard psoriasis treatments, which often include creams or ointments with steroids, IDP-122 Lotion uses a novel formulation of halobetasol propionate. This high-potency corticosteroid is specifically designed to be effective on larger body surface areas while maintaining a once-daily application routine, which is simpler for patients. Researchers are particularly excited because it targets pediatric patients, a group that has limited treatment options, and offers a potentially safer and more convenient approach for managing their symptoms.

What is the effectiveness track record for IDP-122 Lotion in treating psoriasis?

Research shows that IDP-122 Lotion, containing halobetasol propionate, effectively treats plaque psoriasis. Studies have found that applying this lotion significantly improves skin condition in those with plaque psoriasis. Specifically, trials 301 and 302 demonstrated that it effectively reduces the severity of skin patches. The lotion is already approved for use in adults with plaque psoriasis, confirming its effectiveness. This trial focuses on children, and existing data in adults suggests it could also work well for kids. ^{1 2 3 4 6}

Who Is on the Research Team?

Alison Magnotti-Nagel

Principal Investigator

Bausch Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your body produces enough cortisol, a hormone that helps with stress and metabolism, after a special test.

I have moderate to severe psoriasis, not including my face, scalp, underarms, or skin folds.

I have psoriasis covering 10% of my body, not including my face, scalp, underarms, or skin folds.

Exclusion Criteria

I haven't used non-steroid psoriasis creams in the last 14 days or steroid creams in the last 28 days.

Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.

Is considered by the Investigator, for any other reason, to be an unsuitable candidate for 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-122 Lotion to affected areas once daily for 8 weeks

8 weeks

Regular visits for monitoring and blood sample collection

Pharmacokinetics Assessment

Blood samples collected to determine plasma concentrations and PK parameters of IDP-122 Lotion analytes

Days 28-29

Multiple time-point blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IDP-122 Lotion

Trial Overview 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).

How Is the Trial Designed?

Group I: IDP-122 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 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.

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/NCT02514577?tab=results

Safety and Efficacy of IDP-122 in the Treatment ... 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 Trials 301 and 302) to evaluate the efficacy of IDP-122 (halobetasol propionate) Lotion,. 0.01% for the topical treatment of plaque psoriasis.

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-idp-122-lotion-for-children-with-moderate-to-severe-plaque-psoriasis/

Study on the Effects of IDP-122 Lotion for Children with ... The purpose of the study is to evaluate the safety and effects of the IDP-122 Lotion when used by children and teenagers with moderate to severe ...

4. ctv.veeva.com ctv.veeva.com/study/safety-and-efficacy-of-idp-122-in-the-treatment-of-participants-with-plaque-psoriasis-1

Safety and Efficacy of IDP-122 in the Treatment of Participants ... This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe ...

5. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2019-002209-23/PL

Clinical Trials Register Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis. A.3.1, Title of the ...

6. go.drugbank.com go.drugbank.com/drugs/DB00596/clinical_trials?conditions=DBCOND0107033&phase=2&purpose=treatment&status=completed

Ulobetasol Completed Phase 2 Trials for Psoriasis Treatment Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis. Ulobetasol (DB00596) ...