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Study on the Effects of IDP-122 Lotion for Children with Moderate to Severe Plaque Psoriasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The treatment being tested is a lotion called Bryhali, which contains the active ingredient halobetasol propionate. This lotion is applied directly to the skin and is designed to help reduce the symptoms of plaque psoriasis.

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 plaque psoriasis. Participants will apply the lotion once daily for a period of eight weeks. The study will also look at how the body absorbs the medication and its potential impact on the hypothalamic-pituitary-adrenal (HPA) axis, which is a system in the body that helps regulate stress and other important functions.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information about the use of this lotion in young people with plaque psoriasis, helping to improve treatment options for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
The patient attends an initial visit to confirm eligibility for the study. This includes a clinical diagnosis of plaque psoriasis with an Investigator's Global Assessment (IGA) score of 3 or 4, and a body surface area (BSA) involvement of at least 10%.
A physical examination and medical history review are conducted to ensure good general health. Laboratory tests are performed to check hematology and serum chemistry values.
For females of childbearing potential, a negative pregnancy test is required. Effective contraception must be practiced throughout the study.
Step 2
Treatment phase
The patient begins applying IDP-122 Lotion (containing halobetasol propionate 0.01%) topically once daily.
The treatment is administered for a total duration of 8 weeks. The first 4 weeks focus on evaluating systemic exposure, while the full 8 weeks assess safety and potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
Patients are instructed to avoid prolonged exposure of the treatment area to ultraviolet radiation during the study.
Step 3
Follow-up visits
The patient returns to the clinic for regular follow-up visits as required by the study protocol.
These visits include assessments of the treatment's effects, monitoring of any side effects, and evaluation of the patient's overall health status.
Step 4
End of study
Upon completion of the 8-week treatment period, a final evaluation is conducted to assess the outcomes of the study.
The patient may be required to undergo additional tests to ensure no adverse effects have occurred and to evaluate the overall effectiveness of the treatment.

Who can join the trial?

10 criteria

Must be a boy or girl, of any race, aged between 6 years and 16 years and 11 months at the time of giving permission to join the study.
Must be willing to follow the study instructions and come back to the clinic for required visits.
Must have given verbal and written permission to join the study, either by themselves or through a parent or legal guardian.
Must have been diagnosed with **psoriasis**, a skin condition, at the initial visits, with a specific severity score of 3 or 4. Areas like the face, scalp, armpits, and skin folds are not included in this assessment.
Must have an area of **plaque psoriasis** suitable for treatment that covers at least 10% of the body, excluding the face, scalp, armpits, and skin folds.
Must be willing and able to avoid long exposure of the treatment area to sunlight or artificial UV light during the study.
Must be in good general **adrenal health**, as shown by a specific test result for **cortisol**, a hormone, being above a certain level at screening.
Must be in good general health based on medical history and a physical exam, with blood and chemistry tests showing normal or not concerning results.
Girls aged 9 and older who have not started menstruating and those who can become pregnant must have a negative pregnancy test at the start and before applying the study medication.
Girls who can become pregnant and those who have not started menstruating (aged 9 and older) must agree to use effective birth control during the study. This includes methods like birth control pills, IUDs, condoms with spermicide, diaphragms with spermicide, implants, Nuvaring, injections, patches, or abstinence. If using birth control pills, they must have been on the same type for at least three months before the study and not change during the study. If they used birth control pills in the past, they must have stopped at least three months before the study starts.

Who cannot join the trial?

8 criteria

Individuals who do not have plaque psoriasis, a skin condition that causes red, scaly patches on the skin, cannot participate.
People who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Participants who are not willing or able to follow the study procedures cannot participate.
Individuals who have other medical conditions that might interfere with the study cannot participate.
People who are taking medications that could affect the study results cannot participate.
Participants who are pregnant or breastfeeding cannot participate.
Individuals who have participated in another clinical trial recently cannot participate.
People who have allergies to the study medication or its ingredients cannot participate.

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Verified sites

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Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
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Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, Poland

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Investigated drugs

IDP-122 Lotion is a topical treatment being studied for its effects on moderate to severe plaque psoriasis in children. This lotion is applied to the skin once a day. The study aims to understand how the body absorbs the medication and how it affects the body's hormone system, specifically the hypothalamic-pituitary-adrenal (HPA) axis, over a period of 8 weeks. The safety of using this lotion is also being evaluated.

HALOBETASOL PROPIONATE

What is already known about the treatment

IDP-122 Lotion – This medication is administered topically as a lotion and is currently being studied in clinical trials for its safety and effectiveness in treating moderate to severe plaque psoriasis. It is in the phase of evaluating its absorption, systemic pharmacokinetics, and potential to affect the hypothalamic-pituitary-adrenal (HPA) axis. The main therapeutic indication for IDP-122 Lotion is plaque psoriasis, a skin condition characterized by red, scaly patches. The mechanism of action involves the active ingredient, which is a corticosteroid, working at the molecular level to reduce inflammation and suppress the immune response in the skin. This medication is classified pharmacologically as a topical corticosteroid.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic skin condition characterized by the development of thick, red patches covered with silvery-white scales. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The condition results from an accelerated skin cell production process, leading to the buildup of cells on the skin's surface. It can cause itching, discomfort, and sometimes pain. The severity of plaque psoriasis can vary, with some individuals experiencing only minor patches, while others may have widespread areas of affected skin. The condition tends to go through cycles, with periods of flare-ups followed by times of remission.