#1 Clinical Trials Search in Europe

Corticosteroids, Potent (Group Iii)

This article explores a clinical trial investigating the use of lebrikizumab in combination with topical corticosteroids for children and teenagers with moderate to severe atopic dermatitis. The study aims to assess the efficacy, safety, and pharmacokinetics of this treatment approach in patients aged 6 months to under 18 years. We’ll discuss the trial’s objectives, eligibility criteria, and key aspects of the study design.

Table of Contents

What are Corticosteroids?

Corticosteroids are a class of medications that mimic the effects of hormones your body naturally produces in your adrenal glands[1]. These drugs are widely used to reduce inflammation in various conditions, including skin disorders like atopic dermatitis, also known as eczema.

Potent (Group III) Corticosteroids

Corticosteroids are classified into different potency groups based on their strength. Potent (Group III) corticosteroids are a specific category of these medications[1]. They are stronger than mild (Group I) and moderate (Group II) corticosteroids, but not as strong as very potent (Group IV) corticosteroids. This balance of potency makes them suitable for treating moderate to severe cases of atopic dermatitis while minimizing the risk of side effects associated with the strongest corticosteroids.

Use in Atopic Dermatitis

Potent (Group III) corticosteroids are primarily used in the treatment of moderate to severe atopic dermatitis[1]. Atopic dermatitis is a chronic, inflammatory skin condition characterized by itchy, red, and dry skin. These medications work by reducing inflammation, itching, and other symptoms associated with eczema flare-ups.

Application and Dosage

Potent (Group III) corticosteroids are typically applied topically, meaning directly to the skin[1]. The specific dosage and frequency of application can vary depending on the severity of the condition and the specific product being used. Generally, these medications are used sparingly and for short periods to manage flare-ups.

According to the clinical trial information, the maximum treatment period for topical corticosteroids in this study was 18 weeks[1]. However, it’s important to note that in regular clinical practice, the duration of use may be shorter and should be determined by a healthcare provider.

Potential Side Effects

While potent corticosteroids are effective in treating atopic dermatitis, they can have side effects, especially with prolonged use. Some potential side effects include:

  • Thinning of the skin
  • Changes in skin color
  • Increased risk of skin infections
  • Acne or rosacea-like eruptions
  • Stretch marks

It’s crucial to use these medications as directed by a healthcare provider to minimize the risk of side effects[1].

Precautions and Considerations

When using potent (Group III) corticosteroids, there are several important considerations:

  1. Age and weight restrictions: The clinical trial mentioned specific age and weight criteria for participants, indicating that these factors are important when prescribing these medications[1].
  2. Duration of use: These medications are typically used for short periods to manage flare-ups rather than as a long-term treatment[1].
  3. Combination therapy: In some cases, corticosteroids may be used in combination with other treatments for atopic dermatitis[1].
  4. Medical history: It’s important to inform your healthcare provider about any current infections, allergies, or other medical conditions before using these medications[1].
  5. Pregnancy and breastfeeding: The use of these medications during pregnancy or while breastfeeding should be discussed with a healthcare provider[1].

Always consult with a healthcare professional before starting or changing any treatment regimen for atopic dermatitis. They can provide personalized advice based on your specific condition and medical history.

Aspect Details
Study Title A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Main Objective Evaluate efficacy of lebrikizumab with TCS treatment vs. placebo in moderate-to-severe AD
Study Design Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study
Age Range 6 months to <18 years
Primary Endpoints 1. IGA score 0 or 1 with ≥2 point reduction from baseline
2. EASI-75 (≥75% reduction in EASI score from baseline)
Corticosteroid Use Potent (Group III) corticosteroids, applied topically
Treatment Duration Up to 18 weeks

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness of lebrikizumab when used together with topical corticosteroid treatment, compared to a placebo, in young patients with moderate-to-severe atopic dermatitis.
  • Who can participate in this study? Participants must be between 6 months and 18 years old, have had atopic dermatitis for at least 6 months (if younger than 6 years) or 1 year (if older than 6 years), and meet specific weight requirements. Parents or legal guardians must be able to provide consent and follow study guidelines.
  • What are the main exclusion criteria for the trial? Participants cannot join if they've been in a similar study recently, are pregnant or breastfeeding, have had previous reactions to the study drug or ointments used, have severe infections, have certain medical conditions that could affect safety, or have addictions to drugs or alcohol.
  • How is the effectiveness of the treatment measured? The study measures effectiveness using two primary methods: the percentage of participants achieving an Investigator Global Assessment (IGA) score of 0 or 1 with a reduction of at least 2 points from baseline, and the percentage of participants achieving at least a 75% reduction in their Eczema Area and Severity Index (EASI) score.
  • What role do topical corticosteroids play in this study? Topical corticosteroids are used in combination with lebrikizumab in this study. They are classified as 'potent (group III)' corticosteroids and are applied topically to the skin as part of the treatment regimen being evaluated for effectiveness in managing atopic dermatitis.

Ongoing Clinical Trials on Corticosteroids, Potent (Group Iii)

  • Study of Lebrikizumab and Topical Corticosteroids for Children and Teens with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Poland Spain

Glossary

  • Atopic Dermatitis: A chronic inflammatory skin condition characterized by itchy, red, and dry skin. It's also known as eczema.
  • Lebrikizumab: An investigational drug being studied for its potential in treating atopic dermatitis.
  • Topical Corticosteroids: Steroid medications applied directly to the skin to reduce inflammation and relieve itching.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Investigator Global Assessment (IGA): A tool used by researchers to evaluate the overall severity of a skin condition.
  • Eczema Area and Severity Index (EASI): A standardized method for measuring the extent and severity of atopic dermatitis.
  • Phase 3 Study: A large-scale clinical trial to confirm the effectiveness and monitor side effects of a new drug or treatment.

References

  1. http://clinicaltrials.eu/trial/study-of-lebrikizumab-and-topical-corticosteroids-for-children-and-teens-with-moderate-to-severe-atopic-dermatitis/