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Study on the Effects of IDP-118 Lotion (Tazarotene and Halobetasol Propionate) for Children with Moderate to Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for plaque psoriasis, a skin condition that causes red, scaly patches. The treatment being tested is a lotion called IDP-118, also known as Duobrii, which contains two active ingredients: tazarotene and halobetasol propionate. These ingredients are applied to the skin in the form of a liquid.

The purpose of the study is to evaluate the safety and absorption of the IDP-118 lotion when used by children and teenagers with moderate to severe plaque psoriasis. The study will also look at how the body processes the medication and whether it affects the body’s hormone system, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which is involved in stress response and hormone production.

Participants in the study will apply the lotion to their skin once a day for up to eight weeks. The study will monitor how the medication is absorbed into the body and its potential effects on the participants’ health. This research aims to provide more information about the treatment’s safety and effectiveness for young people with plaque psoriasis.

1 initial visit

During the initial visit, the study team will confirm eligibility based on age, health status, and the presence of moderate to severe plaque psoriasis.

A physical examination will be conducted, and medical history will be reviewed.

A blood test will be performed to check adrenal health and ensure normal cortisol levels.

2 baseline assessment

A baseline assessment will be conducted to evaluate the severity of psoriasis using the Investigator’s Global Assessment (IGA) score.

The affected body surface area (BSA) will be measured, excluding the face, scalp, axillae, and intertriginous areas.

3 treatment phase

The treatment involves applying Duobrii lotion, which contains tazarotene and halobetasol propionate, topically once daily.

The lotion will be applied for a total duration of 8 weeks.

For the first 4 weeks, the focus will be on monitoring systemic exposure to the active ingredients.

4 follow-up visits

Regular follow-up visits will be scheduled to monitor progress and any potential side effects.

The study team will assess the safety of the treatment and check for any signs of hypothalamic-pituitary-adrenal (HPA) axis suppression.

5 final assessment

At the end of the 8-week treatment period, a final assessment will be conducted.

The study team will evaluate the overall effectiveness of the treatment and any changes in the severity of psoriasis.

Who Can Join the Study?

  • Must be a male or female, aged between 12 to 16 years and 11 months at the time of giving permission to participate.
  • Must be willing to follow the study instructions and attend all required clinic visits.
  • Must have given verbal and written permission to participate, along with a parent or legal guardian if needed.
  • Must have a confirmed diagnosis of psoriasis, a skin condition, with a specific severity score of 3 or 4, excluding certain areas like the face and scalp.
  • Must have plaque psoriasis, a type of psoriasis, covering at least 10% of the body, excluding certain areas like the face and scalp.
  • Must be willing to avoid long exposure to sunlight or artificial UV light on the treatment area during the study.
  • Must have healthy adrenal glands, checked by a specific test that measures cortisol, a hormone, levels.
  • Must be in good general health based on medical history and a physical exam, with normal blood test results or results that are not concerning.
  • Females who have started menstruating or can become pregnant must have a negative pregnancy test before starting the study.
  • Females who can become pregnant or have started menstruating must agree to use effective birth control during the study. This includes methods like birth control pills, IUDs, condoms with spermicide, or choosing not to have sex. 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 stopped using birth control pills, it must have been at least three months before the study.

Who Cannot Join the Study?

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of allergic reactions to any of the ingredients in the study lotion are excluded.
  • Patients currently using other treatments for plaque psoriasis must stop those treatments before joining the study.
  • People with certain skin conditions that might interfere with the study results are not eligible.
  • Individuals with a weakened immune system, which means their body has a harder time fighting infections, cannot take part.
  • Patients with a history of certain serious medical conditions, like heart disease or uncontrolled diabetes, are excluded.
  • Anyone who has participated in another clinical trial within the last 30 days is not eligible.
  • Individuals who are unable to follow the study instructions or attend all required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland
NZOZ Przychodnia Specjalistyczna A-DERM-Serwis Czestochowa Poland
Dermedic Jacek Zdybski Ostrowiec Swietokrzyski Poland

Other Sites

Site Name City Country Status
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne Swidnik Poland
Cpyfsaw Meadzpyx Lgjwsfu Jazayr Łdng Chojnice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.09.2020

Trial locations

Investigated drugs:

IDP-118 Lotion: This is a topical treatment used in the study for pediatric patients with moderate to severe plaque psoriasis. The lotion contains two active ingredients: HP and Taz. It is applied to the skin once daily. The study aims to evaluate how well the body absorbs these ingredients, their effects on the body, and any potential impact on the body’s hormone regulation system over a period of 8 weeks.

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 and others having widespread, severe outbreaks. The condition tends to go through cycles, with periods of flare-ups followed by times of remission.

Trial ID:
2024-520057-20-00
Protocol code:
V01-118A-401
Trial Phase:
Therapeutic exploratory (Phase II)

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