NCT04271007

Comparative Study:Topison (Mometasone Furoate) Versus Two Others Mometasone Furoates

Phase IV Clinical Study,Comparative, Blind Double and Randomized to Compare Mometasone Furoate Cream (TOPISON) Versus Other Two Cream Mometasone Furoate, in Participants With Atopic Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Libbs Farmacêutica LTDA · Industry
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Atopic dermatitis is a chronic disease, with outbreaks, predominant in childhood, whose main symptom is pruritus of variable intensity and signs of cutaneous xerosis and eczematous pattern lesions. In this context, the present study aims to evaluate a comparative way of Topison drugs in reducing transepidermal water loss, improving skin hydration and comfort in participants with atopic dermatitis.

Detailed description

Phase IV, national, single-center, comparative, double-blind, randomized clinical study with instrumental, clinical and subjective tests to compare mometasone cream puncture (Topison) versus two other mometasone cream punctures in participants with atopic dermatitis. 60 research participants of both sexes will be required, aged 10 or over and under or equal to 60 years. Participants will be randomized into two groups, as follows: Group I: Use the drug Topison on one side of the upper limb and Mometasone Furoate 1mg / g Sanofi, Medley on the opposite side. Group II: Use the drug Topison on one side of the upper limb and Mometasone Furoate 1mg / g Aché on the opposite side. The side of the upper limb for the use of Topison or momofasone furoate Sanofi, Medley or Aché will be defined randomly.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Mometasone Furoate	mometasone furoate

Timeline

• Start date: 2020-11-23
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2020-02-17
• Last updated: 2023-10-11

Locations

1 site across 1 country: Brazil