Atopic DermatitisPhase 4LB2001NCT04271007
Comparative Study:Topison (Mometasone Furoate) Versus Two Others Mometasone Furoates
A Phase 4 study testing Mometasone Furoate in people with Atopic Dermatitis, run by Libbs Farmacêutica LTDA at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Mometasone Furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Nov 2020to 10 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Mometasone Furoate
- Keywords
- Topison, Atopic dermatitis, mometasone furoate
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone FuroateDrug
mometasone furoate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Mometasone Furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory evaluation
Compare performance in the immediate burning sensation after the first monitored application, assessed by the research participant through sensory evaluations
Measured: 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.
Measured: after 15 days of using the products.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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:
- 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).
Measured: 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.
Measured: after 15 days of continuous use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start23 Nov 2020
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Libbs Farmacêutica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271007
- Sponsor's protocol ID
- EN19092501
- Acronym
- LB2001
- Status last verified
- Jul 2022
- First submitted
- 12 Feb 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04271007
- Acronym / sponsor ID
- LB2001 / EN19092501
- Conditions
- Atopic Dermatitis
- Keywords
- Topison, Atopic dermatitis, mometasone furoate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Libbs Farmacêutica LTDAIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Mometasone FuroateUse 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 | Drug: Mometasone FuroateUse of the drug Topison on one side of the upper limb and Mometasone Furoate 1mg /g Aché on the opposite side |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone Furoatemometasone furoate | Drug | Group I, Group II |
Primary outcome
sensory evaluation
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
Effectiveness
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.
5 secondary outcomes
Hydrating efficacy using the equipment Corneometer MPA 580 (Courage Khazaka)
Time frame: after 15 days of use using instrumental measures
Sensory parameters (immediate burning, spreadability, feeling of comfort and calming effect)
Time frame: after 15 days of continuous use.
Improvement in atopic dermatitis symptoms:erythema, edema, excoriation, crust, lichenification, dry skin and pruritus
Time frame: after 15 days of continuous use
Improvement in atopic dermatitis symptoms (questionnaire)
Time frame: after 15 days of continuous use
Preference assessment
Time frame: after 15 days of continuous use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone Furoate in people with Atopic Dermatitis, run by Libbs Farmacêutica LTDA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory evaluation (time frame: up to 5 minutes after first monitored aplication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.