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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate | Drug | mometasone furoate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Sérgio Sckalka | Osasco | São Paulo | 06023000 | Brazil |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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.
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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.
| after 15 days of use using instrumental measures |
| 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. |
| 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 |
| 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:
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 |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |