Comparative Study:Topison (Mometasone Furoate) Versus Two Others Mometasone Furoates
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Atopic Dermatitis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: 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 Ache 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.Masking: Double (Participant, Investigator)Masking Description: To allow the study to be blinded, each participant will receive the product from the non-blind professional, delegated by the Principal Investigator, according to the allocation generated through the randomization list. Uncharacterized products will be dispensed with, making it impossible to identify them. The cream that each participant will receive will be non-transferable and confidential to the other research participants and to the employees of the research center, except for the non-blind professional; therefore, the research center should guide this conduct when dispensing. The Sponsor will delegate a non-blind monitor other than the monitors responsible for the study's monitoring. The non-blind monitor will be responsible only for checking the randomization, accounting and adherence of the returned medication. This conference should be held in a room isolated from the other monitors in the study and other professionals in the research center.Primary Purpose: Other
Participation Requirements
- Age
- Between 10 years and 60 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04271007
- Collaborators
- Not Provided
- Investigators
- Not Provided
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