Clinical trial NCT04271007: Comparative Study:Topison (Mometasone Furoate) Versus Two Others Mometasone Furoates
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Topison
Atopic dermatitis
mometasone furoate
Lead sponsor: Libbs Farmacêutica LTDA
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: sensory evaluation
timeFrame: up to 5 minutes after first monitored aplication
measure: Effectiveness
timeFrame: after 15 days of using the products.
Secondary outcomes:
measure: Hydrating efficacy using the equipment Corneometer MPA 580 (Courage Khazaka)
timeFrame: after 15 days of use using instrumental measures
measure: Sensory parameters (immediate burning, spreadability, feeling of comfort and calming effect)
timeFrame: after 15 days of continuous use.
measure: Improvement in atopic dermatitis symptoms:erythema, edema, excoriation, crust, lichenification, dry skin and pruritus
timeFrame: after 15 days of continuous use
measure: Improvement in atopic dermatitis symptoms (questionnaire)
timeFrame: after 15 days of continuous use
measure: Preference assessment
timeFrame: after 15 days of continuous use
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Dr Sérgio Sckalka
state: São Paulo
Study officials:
References: