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

Atopic Dermatitis Clinical Trial

— LB2001  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271007
• Other study ID #: EN19092501
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2020
• Est. completion date: July 10, 2023

Study information

• Verified date: July 2022
• Source: Libbs Farmacêutica LTDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Mometasone Furoate
mometasone furoate

Locations

Country	Name	City	State
Brazil	Dr Sérgio Sckalka	Osasco	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Libbs Farmacêutica LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hydrating efficacy using the equipment Corneometer MPA 580 (Courage Khazaka)	Compare the hydrating efficacy of Topison cream medications and two other Mometaona Furoate products after 15 days of use using instrumental measures by the Corneometer® equipment.Corneometer equipment measures skin hydration by capacitance. A device probe is a capacitor that, during a measurement, forms an electric field that is interfered by the water present in the skin. The device displays the amount of water present in the arbitrary units, intrinsic to the equipment, from 0 to 130. Without changes, a probe / capacitor interprets the result as 0 and, when affected by the water present on the skin, it presents higher results. The greater the amount of water present on the skin, the higher the result of the application, therefore, it is expected that the values will increase after the application of the product.	after 15 days of use using instrumental measures
Secondary	Sensory parameters (immediate burning, spreadability, feeling of comfort and calming effect)	Compare the performance of Topison cream and two other Mometasone Furoate products through sensory parameters, evaluated by the research participant after the first monitored application and after 15 days of continuous use.The participant will evaluate: Regarding the immediate burning sensation after applying the product, the alternative applicable to what was felt:Intense, moderate, light, very light, absent (without burning).About product spreadability:very difficult (impossible to spread),spreadability difficult, normal, easy, spreadability very easy (pleasant) If the product provides a comfortable feeling for the skin: strongly disagree, disagree, I do not agree nor disagree,accept,I fully agree. And finally, if the product provides a calming effect for your skin: completely disagree, disagree, neither agree nor disagree, agree, fully agree.	after 15 days of continuous use.
Secondary	Improvement in atopic dermatitis symptoms:erythema, edema, excoriation, crust, lichenification, dry skin and pruritus	Compare the improvement in atopic dermatitis symptoms between Topison cream and two other Mometasone Furoate products after 15 days of continuous use, compared to baseline thorugh clinical evaluation performed by dermatologist.The dermatologist will evaluate the signs and symptoms: erythema, edema, abrasion, crust, lichenification, dry skin and itching according to an intensity scale: absent (0), mild (1), moderate (2) and this scale (zero) represents the best result and 3 the worst.	after 15 days of continuous use
Secondary	Improvement in atopic dermatitis symptoms (questionnaire)	Compare the improvement in atopic dermatitis symptoms between Topison cream and two other Mometasone Furoate products after 15 days of continuous use, using a questionnaire evaluated by the research participant.The participant will answer two questions in this questionnaire: hydration status of your skin after using the product; If the product reduces any itchy sensations on the skin.; The answer options for both questions will be: it got worse, it didn't change, it improved little, it improved modernly or it improved (following a descriptive scale from the worst scenario to the best).	after 15 days of continuous use
Secondary	Preference assessment	Assess which product the research participant prefers, among the two he has used, after 15 days of continuous use.The subject will inform if the best product was applied to the right or left arm.	after 15 days of continuous use