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

NCT04271007 | Completed Phase 4

• 1 other identifier: EN19092501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Topison; Atopic dermatitis; mometasone furoate

Outcome Measures

Primary Outcomes (2)

• sensory evaluation

  Compare performance in the immediate burning sensation after the first monitored application, assessed by the research participant through sensory evaluations

  up to 5 minutes after first monitored aplication

• Effectiveness

  Compare the effectiveness of Topison cream and two other Mometasone Furoate products in reducing transepidermal water loss by Evaporimetry (TEWL) after 15 days of using the products.

  after 15 days of using the products.

Secondary Outcomes (5)

• Hydrating efficacy using the equipment Corneometer MPA 580 (Courage Khazaka)

  after 15 days of use using instrumental measures

• Sensory parameters (immediate burning, spreadability, feeling of comfort and calming effect)

  after 15 days of continuous use.

• Improvement in atopic dermatitis symptoms:erythema, edema, excoriation, crust, lichenification, dry skin and pruritus

  after 15 days of continuous use

• Improvement in atopic dermatitis symptoms (questionnaire)

  after 15 days of continuous use

• Preference assessment

  after 15 days of continuous use

Study Arms (2)

Group I

ACTIVE COMPARATOR

Use of the drug Topison on one side of the upper limb and Mometasone Furoate 1mg /g Sanofi, Medley on the opposite side

Drug: Mometasone Furoate

Group II

ACTIVE COMPARATOR

Use of the drug Topison on one side of the upper limb and Mometasone Furoate 1mg /g Aché on the opposite side

Drug: Mometasone Furoate

Interventions

Mometasone Furoate DRUG

mometasone furoate

Group I; Group II

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ability to understand and consent / consent to their participation in this clinical study, manifested by signing the Informed Consent Form and, when applicable, the Informed Consent Form and the responsible consent form;
• Participants of both sexes aged 10 or over and less than or equal to 60 years;
• Participant with a previous history of atopic dermatitis (who has had at least one crisis in his life);
• Presence of active lesions of atopic dermatitis in the upper limbs in a symmetrical way that allows the treatment of two different regions with two different products. Both lesions must be present with the following symptoms: dry skin, itching and erythema with mild (1) or moderate (2) intensity, assessed using the scale: 0: absent, 1: mild; 2: moderate and 3: intense;
• Agreement to follow the trial procedures and attend the clinic on certain days and times.

You may not qualify if:

• Pregnancy / lactation or intention to record during the study period;
• Women who do not agree to use acceptable contraceptive methods (oral contraceptive, injectable contraceptive, intrauterine device (IUD), hormonal implant, barrier methods, hormonal transdermal patch and tubal ligation); except for those that are surgically sterile (bilateral oophorectomy or hysterectomy), as menopausal women for at least 01 (one) year and as participants who declared that they did not practice sexual practices or exercise in a non-reproductive manner;
• Male participants who do not agree to use acceptable contraceptive methods:
• Contraceptive methods for the participant: barrier condom, except for those who are surgically sterile (vasectomy) or for a participant in sexual abstinence; Contraceptive methods for partner: oral contraceptive, injectable contraceptive, intrauterine device (IUD), hormonal implant, hormonal transdermal patch, tubal ligation and pressure inhibition methods for women who are sterile (bilateral oophorectomy or hysterectomy), menopausal at least 01 (one) year;
• Use of the following medications for topical or systemic use: antihistamines, non-hormonal anti-inflammatory drugs, antibacterial, antifungal and corticoid with no period less than or equal to 30 days before the selection data;
• Participants with fungal and / or bacterial infections at the time of selection;
• Decompensated endocrinopathies;
• Relevant or current medical history of alcohol or other drug abuse;
• Known history or suspected intolerance / allergy to products of the same category or components of the formula;
• Intense sun exposure up to 15 days before the evaluation;
• Aesthetic or dermatological treatment in the evaluation area up to 4 weeks before selection;
• Professionals directly involved in carrying out the present study;
• Other conditions of use by the evaluating physician as reasonable to disqualify participation in the study. If so, it can be described under observation in the clinical record.
• Use of the following medications for topical or systemic use: antihistamines, non-inflammatory drugshormonal, antibacterial, antifungal, immunosuppressive and corticosteroids in the period less than or equal to 30 daysbefore the date of selection.

Sponsors & Collaborators

• Libbs Farmacêutica LTDA: lead

Study Sites (1)

Dr Sérgio Sckalka

Osasco, São Paulo, 06023000, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: November 23, 2020
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: October 11, 2023

Record last verified: 2022-07

Locations

BR (1)