In short
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.
At a glance
- 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
What is Mometasone Furoate?
Mometasone Furoate is a potent corticosteroid medication used to treat various skin conditions, including plaque psoriasis. 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.
Treating Plaque Psoriasis
Plaque psoriasis is a chronic skin condition characterized by red, scaly patches on the skin. 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.
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. 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).
Eligibility Criteria
The trial has specific criteria for participants, including:
- Adults aged 18 to 65 years
- Confirmed diagnosis of stable plaque psoriasis
- Mild severity of psoriasis, affecting no more than 10% of body surface area
- Two comparable psoriatic areas for treatment on the body (excluding face, scalp, neck, palms, soles, and skin folds)
Certain conditions may exclude participation, such as pregnancy, breastfeeding, or other forms of psoriasis like guttate or pustular psoriasis.
Treatment Details
In the clinical trial, participants are randomly assigned to different treatment groups. They apply either:
- The new mometasone furoate emulsion
- Ecural® fat cream (an existing treatment)
- 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.
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
- More effective than the vehicle (cream without active ingredient)
- Safe for use in treating plaque psoriasis
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.