#1 Clinical Trials Search in Europe

Mometasone Furoate Ph. Eur.

This article discusses a clinical trial investigating the use of Mometasone Furoate Ph. Eur., a potent corticosteroid, in treating plaque psoriasis. The study compares a 0.1% mometasone furoate cutaneous emulsion with a comparator product and a vehicle (inactive base) to assess its effectiveness and safety in adult patients with stable plaque psoriasis.

Table of Contents

What is Mometasone Furoate?

Mometasone Furoate is a potent corticosteroid medication used to treat various skin conditions, including plaque psoriasis[1]. It belongs to a group of drugs known as corticosteroids, potent (group III), which are effective in reducing inflammation and relieving symptoms associated with certain skin disorders[1].

Treating Plaque Psoriasis

Plaque psoriasis is a chronic skin condition characterized by red, scaly patches on the skin[1]. Mometasone Furoate is being studied as a potential treatment for this condition. It is applied topically, which means it is used directly on the skin where the psoriasis plaques appear[1].

Clinical Trial Overview

A Phase III clinical trial is being conducted to evaluate the effectiveness and safety of a 0.1% mometasone furoate cutaneous emulsion for treating plaque psoriasis in adults[1]. This trial aims to compare the new formulation with an existing product called Ecural® fat cream and a vehicle (a cream without the active ingredient)[1].

Eligibility Criteria

The trial has specific criteria for participants, including:

  • Adults aged 18 to 65 years[1]
  • Confirmed diagnosis of stable plaque psoriasis[1]
  • Mild severity of psoriasis, affecting no more than 10% of body surface area[1]
  • Two comparable psoriatic areas for treatment on the body (excluding face, scalp, neck, palms, soles, and skin folds)[1]

Certain conditions may exclude participation, such as pregnancy, breastfeeding, or other forms of psoriasis like guttate or pustular psoriasis[1].

Treatment Details

In the clinical trial, participants are randomly assigned to different treatment groups[1]. They apply either:

  1. The new mometasone furoate emulsion
  2. Ecural® fat cream (an existing treatment)
  3. A vehicle (cream without active ingredient)

The medication is applied once daily for 21 days, with the amount depending on the size of the affected skin area[1].

Safety and Effectiveness

The main goals of the study are to determine if the new mometasone furoate emulsion is:

  • As effective as Ecural® fat cream in treating plaque psoriasis[1]
  • More effective than the vehicle (cream without active ingredient)[1]
  • Safe for use in treating plaque psoriasis[1]

The effectiveness is measured by observing changes in the Total Sign Score (TSS), which considers factors like redness, thickness, and scaling of the psoriasis plaques[1].

Aspect Details
Study Type Phase III, multicentre, randomised, observer-blind, intraindividual, paired, comparative trial
Main Objective To evaluate the efficacy and safety of 0.1% mometasone furoate cutaneous emulsion compared to Ecural® fat cream and vehicle
Participants Adults aged 18-65 with stable plaque psoriasis
Treatment Duration 21 days
Primary Endpoint Percentage change from baseline in Total Sign Score (TSS) on Day 22
Secondary Endpoints Percentage change from baseline in TSS on Day 8, Changes from baseline in TSS on Days 8 and 22
Safety Assessment Comparison of safety profile between test product, comparator, and vehicle

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to demonstrate that the 0.1% mometasone furoate cutaneous emulsion is as effective as the comparator product and better than the vehicle in treating chronic stable plaque-type psoriasis.
  • Who can participate in this trial? Adults aged 18 to 65 with stable plaque psoriasis, having two comparable psoriatic areas for treatment on the extremities or trunk, and meeting specific criteria for disease severity.
  • How long does the treatment last? The treatment period lasts for 21 days, with participants applying the medication once daily.
  • What is the primary way of measuring the treatment's effectiveness? The primary measure is the percentage change from baseline in the Total Sign Score (TSS), which includes erythema, induration, and scaling, on Day 22 of the trial.
  • Are there any restrictions on other psoriasis treatments during the trial? Yes, participants must avoid other topical, systemic, or phototherapy treatments for psoriasis for specified periods before and during the trial to ensure accurate results.

Ongoing Clinical Trials on Mometasone Furoate Ph. Eur.

  • Study on the Effectiveness and Safety of 0.1% Mometasone Furoate Emulsion and Ecural Cream for Adults with Plaque Psoriasis

    Not recruiting

    3 1 1
    Investigated drugs:
    Poland

Glossary

  • Plaque psoriasis: A common form of psoriasis characterized by raised, red patches covered with a silvery white buildup of dead skin cells, typically appearing on the scalp, knees, elbows, and lower back.
  • Mometasone Furoate: A potent corticosteroid used in topical treatments for various skin conditions, including psoriasis, to reduce inflammation and relieve symptoms.
  • Cutaneous emulsion: A topical preparation where tiny droplets of oil are suspended in water, used to deliver medication to the skin.
  • Total Sign Score (TSS): A measure used to assess the severity of psoriasis, combining scores for erythema (redness), induration (thickness), and scaling of the affected skin.
  • Vehicle: The inactive base of a topical medication that carries the active ingredient. In clinical trials, it's often used as a control to compare with the active treatment.
  • Erythema: Redness of the skin caused by increased blood flow to superficial capillaries, often seen in inflammatory skin conditions like psoriasis.
  • Induration: Hardening or thickening of the skin, which is a common feature in plaque psoriasis.
  • Body Surface Area (BSA): A measurement used to estimate the percentage of the body affected by a skin condition, often used in assessing psoriasis severity.
  • Non-inferiority trial: A type of clinical trial designed to demonstrate that a new treatment is not worse than a standard treatment by more than a pre-specified margin.
  • Topical administration: Application of a medication directly to the skin surface.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-0-1-mometasone-furoate-emulsion-and-ecural-cream-for-adults-with-plaque-psoriasis/