Dr Sérgio Sckalka
Osasco, São Paulo, 06023000, Brazil
NCT Number: NCT04271007
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.
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Notify Me10 year–60 year
All sexes
Interventional
Phase 4
Osasco, São Paulo, 06023000, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
mometasone furoate
Time frame: up to 5 minutes after first monitored aplication
Compare performance in the immediate burning sensation after the first monitored application, assessed by the research participant through sensory evaluations
Time frame: after 15 days of using the products.
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.
Time frame: after 15 days of use using instrumental measures
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.
Time frame: after 15 days of continuous use.
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.
Time frame: after 15 days of continuous use
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.
Time frame: after 15 days of continuous use
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).
Time frame: after 15 days of continuous use
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.
Libbs Farmacêutica LTDA
Industry
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
Acronym: LB2001
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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