Atopic DermatitisPhase 4NCT03388866
Effect of Sublingual Immunotherapy in Patients With Atopic Dermatitis
A Phase 4 study testing Mite extract sublingual immunotherapy (SLIT) in people with Atopic Dermatitis and Effects of Immunotherapy, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
Trial summary
Atopic dermatitis (AD) is a chronic and recurrent inflammatory disease, prevalent between 1 and 20% in the world population, with a predominance of childhood, but which may be present in adult life. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Atopic Dermatitis, Effects of Immunotherapy
- What is being tested?
- Mite extract sublingual immunotherapy (SLIT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2018to 26 Jun 2020
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of AD according to Hanifin and Rajka criteria;
- Age greater than or equal to 3 years;
- SCORAD equal to or greater than 15 points;
- Presence of skin tests and / or specific IgE positive for Dermatophagoides pteronyssinus and / or Dermatophagoides farinae;
Who cannot join
- Pregnancy or breastfeeding;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Effect of Sublingual Immunotherapy With Mite Extract in Patients With Atopic Dermatits: Placebo-controlled Double-blind Randomized Study
Atopic dermatitis (AD) is a chronic and recurrent inflammatory disease, prevalent between 1 and 20% in the world population, with a predominance of childhood, but which may be present in adult life. AD results from a complex interaction between genetic and environmental factors, with the presence of a defect in the skin barrier and deregulation of the immune response, culminating in an inflammatory response in the skin predominantly type 2. Disease control is based on restoring skin hydration, smoothing itching and controlling the process specific sensitizing agents such as inhalant allergens and foods that may pathogenesis of the disease. In selected patients who present IgE mediated response to inhalant allergens, allergen-specific immunotherapy can be effective. Classically, the subcutaneous route is the most used, however, sublingual immunotherapy (SLIT) has been used in increasing form. There are still few studies on the efficacy and safety of SLIT in atopic dermatitis. Therefore, the present study aims to to investigate the role of SLIT in the management of patients with AD allergic mites, through a randomized, double-blind and placebo-controlled study
Read the detailed description
A total of 94 patients, 3 years of age or older, with clinical diagnosis of AD, without distinction of gender, ethnicity or social group, will be selected at HCFMRP-USP Allergy and Dermatology outpatient clinics. These patients will undergo clinical evaluation and laboratory tests, including blood count, total IgE, inhalant panel specific IgE, and immediate hypersensitivity skin tests, and mite allergen-specific IgG4 (Der p 1 and Der p 2), before of the study. To calculate the sample size, a response rate to the medication was defined as a 15 - point decrease in SCORAD (a score that includes lesion extent, intensity and subjective symptoms such as pruritus and sleep), which was determined through the experience of the service. It was estimated that 40% of the patients in the treatment group and 15% of the placebo group reached the proposed rate through a test with 80% power, and the need for 47 individuals in each group was defined.
Patients in the treatment group will undergo allergen-specific immunotherapy sublingually, with weekly doses of extracts of mites Dermatophagoides pteronyssinus and Dermatophagoides farinae (60% and 40% respectively), according to the scheme described in Tables 1 and 2. Patients in the control group will be submitted to the same administration schedule, but with the diluent of the allergenic extract (doubly distilled water solution and glycerin). Patients will be divided into groups according to randomization.
Subjects will be randomly divided into blocks of random size 4 or 6 and stratified according to age (less than 12 years and greater / equal 12 years), performed through the RedCap platform, available at FMRPUSP. This process will be performed by laboratory staff who will provide the extracts and the researchers will not have access to the lists of patients in each group. As for blinding, the bottles with extract and placebo will be provided by the already coded laboratory, and the team will only be responsible for the delivery and storage of the same.
Table 1 - Weekly dose schedule Monday Wednesday Friday
- st week 1 drop 2 drops 4 drops
- nd week 6 drops 8 drops 8 drops
Table 2 - Monthly Dilution Schedule Dilution of mite extract
1st and 2nd weeks (1st month) 1: 1000000 v: v 3rd and 4th weeks (1st month) 1: 100000 v: v
1st and 2nd weeks (2nd month)1: 10000 v: v 3rd and 4th weeks (2nd month) 1:1000 v: v
1st and 2nd weeks (3rd month) 1: 100 v:v 3rd and 4th weeks (3rd month) 1:10 v:v 3rd to 18th month 1:10 v: v
Individuals will be the outpatient clinics of the Allergy and Dermatology Service of the HCFMRP-USP. All medical records and clinical and dermatological examination will be recorded in medical records, as well as clinical evaluation by SCORAD , quality of life questionnaire and personal scale of symptoms, being evaluated at the beginning of treatment, after two, three, six, nine, twelve, fifteen and eighteen months of evolution.
Serum levels of IgG4 specific mite for Der p 1 and Der p 2 will be determined by ImmunoCAP and evaluated at the beginning and the end of treatment. Interleukins 4, 5, 9, 10 13, 17, TNFα, TGFβ and interferon-γ will be performed in plasma in the beginning, with 9 months of evolution and at the end of the study.
- Conditions
- Atopic Dermatitis, Effects of Immunotherapy
- Being tested
- Mite extract sublingual immunotherapy (SLIT), Placebo
- Keywords
- inhaled aeroallergens, eczema, pruritus, life quality, immunotheraphy, atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mite extract sublingual immunotherapy (SLIT)Drug
Also called Allergen specific sublingual immunotherapy, Sublingual immunotherapy (SLIT)
Administration of increasing weekly doses of extracts of mites Dermatophagoides pteronyssinus in the treatment group.
PlaceboOther
Also called Diluent of the allergenic extract
Placebo group will be submitted to administration of increasing weekly doses, but with diluent of the allergenic extract (doubly distilled water solution and glycerin).
| Study group | Role | What they receive |
|---|---|---|
| Mite extract sublingual immunotherapy | Active comparator | Use of mite extract sublingual immunotherapy (SLIT) with increasing weekly doses of extracts of mite Dermatophagoides pteronyssinus, as represented below:
Weekly dose schedule Monday Wednesday Friday
1. st week 1 drop 2 drops 4 drops
2. nd week 6 drops 8 drops 8 drops
Monthly Dilution Schedule Dilution of mite extract
1st and 2nd weeks (1st month) 1: 1000000 v: v 3rd and 4th weeks (1st month) 1: 100000 v: v
1st and 2nd weeks (2nd month)1: 10000 v: v 3rd and 4th weeks (2nd month) 1:1000 v: v
1st and 2nd weeks (3rd month) 1: 100 v:v 3rd and 4th weeks (3rd month) 1:10 v:v 3rd to 18th month 1:10 v: v Receives: Drug: Mite extract sublingual immunotherapy (SLIT) |
| SLIT placebo | Placebo comparator | Patients in the control group will be submitted to the same administration schedule, but with allergen extract diluent (doubly distilled water solution and glycerin), as described below:
Weekly dose schedule Monday Wednesday Friday
1. st week 1 drop 2 drops 4 drops
2. nd week 6 drops 8 drops 8 drops
Intervention: Placebo - Immunotherapy allergen diluent Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Severity Scoring of Atopic Dermatitis (SCORAD)
The SCORAD is calculated using the extent of the injury, intensity and subjective symptoms, the formula used for the calculation is A / 5 + 7B / 2 + C (A - extent B - intensity C-subjective symptoms). The extent can vary from zero to 100, applying the nine rule also used in large burned patients. The intensity varies from zero to 18, divided into six items, including erythema, edema, excoriation, lichenification, and dryness. Subjective symptoms range from zero to 30 evaluated by means of analog pruritus scale and sleep.
The SCORAD severity rating is:
0-20 mild 20-40 moderate > 40 severe
Based on our clinical experience, it was decided to consider as the main outcome a 15-point decrease in SCORAD,in any degree of severity, in 40% of subjects in the treatment group and 15% in the placebo group.
Measured: Measures at baseline and after 18 months
Secondary outcomes (8)
EASI (Eczema Area and Severity Index)
EASI is based on the extension and severity of Atopic Dermatitis. To obtain EASI, the proportion of body areas are taken into consideration, with head being equivalent to 10%, trunk 30%, upper extremities 20% and lower extremities 40%. The percentage of involvement of these four regions is determined using a scale of 0 to 6. Clinical signs including erythema, infiltration and/or papulation, excoriation, and lichenification are evaluated each on a scale of 0 to 3.
Final score is calculated using the formula below. Severity is classified as: 0 = clear; 0.1 - 1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. Any reduction in the EASI score will be accepted as a positive outcome.
Measured: 3, 6, 9, 12, 15 and 18 months
IGA (Investigator Global Assessment)
IGA consists of evaluation of the severity of Atopic Dermatitis considering the inflammatory signs of the disease (erythema, papulation and infiltration). IGA is calculated according to the following scale: clear; almost clear; mild disease; moderate disease; severe disease; and very severe disease.
IGA score 0 or 1 after 18 months of treatment will be accepted as a positive outcome.
Measured: 3,6,9,12,15 and 18 months
DLQI (Dermatology Life Quality Index)
The DLQI is a questionnaire of 10 questions used to measure how much skin problems affect patient´s life in the past seven days.
The scoring of each question is as follows:
Very much, score of 3; A lot, score of 2; A little, score of 1; Not at all, score of 0; Not relevant, score of 0. Question 7, 'prevented work or studying', score of 3. The DLQI is calculated by summing the score for each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
How to interpret meaning of DLQI scores:
0 - 1 no effect at all on patient's life; 2 - 5 small effect on patient's life; 6 - 10 moderate effect on patient's life; 11 - 20 very large effect on patient's life; 21 - 30 extremely large effect on patient's life.
The decrease of 4 or more points in DLQI is a secondary outcome measure.
Measured: 3, 6, 9, 12,15 and 18 months
Analog Visual Scale of Symptoms
The analog visual scale consists of three questions that can be answered using a scale of 0 to 10, as described below:
How much your skin itched last week? How much your skin peeled last week? How atopic dermatitis interfered with last week's sleep? Any reduction in the analog visual scale will be accepted as a positive outcome
Measured: 3, 6, 9, 12,15 and 18 months
Pruritus scale
Patients will provide information on their perception of pruritus in their daily life. The evaluation is subjective, varying from absence of pruritus to severe pruritus.
Any reduction in the Pruritus scale will be accepted as a positive outcome
Measured: 3, 6, 9, 12, 15 and 18 months
IgG4 antibodies to mite allergens Der p 1, Der p 2 and Der p 10
It has been consistently shown that both subcutaneous and sublingual immunotherapy increase levels of specific IgG4 antibodies. Therefore, we expect to find an increase in levels of IgG4 to mite allergens at the end of treatment. IgG4 specific to Der p 1, Der p 2 and Der p 10 can be measured by ImmunoCAP.
Measured: 0 and 18 months
Specific IgE antibodies to purified allergens and to Staphylococcal allerg
IgE antibodies to a panel of purified allergens will be assessed by ImmunoCAP and ImmunoCAP-ISAC, including Dermatophagoides pteronyssinus allergens rDer p1, rDer p 2 e rDer p 10. In addition, levels of specific IgE to Staphylococcal enterotoxins, including enterotoxins A, B, C and TSST, will be determined in patients' sera before and after treatment. It is expected that levels of IgE antibodies to mite allergens and to Staphylococcal enterotoxins will be decreased at the end of treatment
Measured: 0 and 18 months
Type 2 and regulatory cytokines
Reduction in type 2 cytokine group (IL4, IL5, IL9 and IL13) Regulatory cytokines [Time Frame: 0, 9 and 18 months] Increase of regulatory cytokines (IL-10 and TGF-beta)
Measured: 0, 9 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start2 May 2018
- Primary completion30 Oct 2019
- Study completion26 Jun 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 94 patients, 3 years of age or older, with clinical diagnosis of AD, without distinction of gender, ethnicity or social group, will be selected at HCFMRP-USP Allergy and Dermatology outpatient clinics. These patients will undergo clinical evaluation and laboratory tests, including blood count, total IgE, inhalant panel specific IgE, and / or immediate hypersensitivity skin tests, and mite allergen specific IgG4 (Der p 1 and Der p 2), before of the study. Patients in the treatment group will undergo sublingual allergen-specific immunotherapy with weekly and weekly doses of extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae mites (60% and 40% respectively), according to the predetermined schedule. Patients in the control group will be submitted to the same administration schedule, but with allergen extract diluent (doubly distilled water solution and glycerin).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Espirita Terra de Ismael
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Fabio Carmona, Casa Espirita Terra de Ismael
- Investigators
- Karla L Arruda, PhD, Study director, Faculdade de Medicina de Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388866
- Sponsor's protocol ID
- SLIT_AD1
- Status last verified
- Aug 2020
- First submitted
- 22 Nov 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sublingual Immunotherapy With Mite Extract in Patients With Atopic Dermatits: Placebo-controlled Double-blind Randomized Study
- ClinicalTrials.gov ID
- NCT03388866
- Acronym / sponsor ID
- SLIT_AD1
- Conditions
- Atopic Dermatitis, Effects of Immunotherapy
- Keywords
- inhaled aeroallergens, eczema, pruritus, life quality, immunotheraphy, atopic dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Casa Espirita Terra de IsmaelUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 3 Jan 2018 (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 (AD) is a chronic and recurrent inflammatory disease, prevalent between 1 and 20% in the world population, with a predominance of childhood, but which may be present in adult life. AD results from a complex interaction between genetic and environmental factors, with the presence of a defect in the skin barrier and deregulation of the immune response, culminating in an inflammatory response in the skin predominantly type 2. Disease control is based on restoring skin hydration, smoothing itching and controlling the process specific sensitizing agents such as inhalant allergens and foods that may pathogenesis of the disease. In selected patients who present IgE mediated response to inhalant allergens, allergen-specific immunotherapy can be effective. Classically, the subcutaneous route is the most used, however, sublingual immunotherapy (SLIT) has been used in increasing form. There are still few studies on the efficacy and safety of SLIT in atopic dermatitis. Therefore, the present study aims to to investigate the role of SLIT in the management of patients with AD allergic mites, through a randomized, double-blind and placebo-controlled study
Detailed description
A total of 94 patients, 3 years of age or older, with clinical diagnosis of AD, without distinction of gender, ethnicity or social group, will be selected at HCFMRP-USP Allergy and Dermatology outpatient clinics. These patients will undergo clinical evaluation and laboratory tests, including blood count, total IgE, inhalant panel specific IgE, and immediate hypersensitivity skin tests, and mite allergen-specific IgG4 (Der p 1 and Der p 2), before of the study. To calculate the sample size, a response rate to the medication was defined as a 15 - point decrease in SCORAD (a score that includes lesion extent, intensity and subjective symptoms such as pruritus and sleep), which was determined through the experience of the service. It was estimated that 40% of the patients in the treatment group and 15% of the placebo group reached the proposed rate through a test with 80% power, and the need for 47 individuals in each group was defined.
Patients in the treatment group will undergo allergen-specific immunotherapy sublingually, with weekly doses of extracts of mites Dermatophagoides pteronyssinus and Dermatophagoides farinae (60% and 40% respectively), according to the scheme described in Tables 1 and 2. Patients in the control group will be submitted to the same administration schedule, but with the diluent of the allergenic extract (doubly distilled water solution and glycerin). Patients will be divided into groups according to randomization.
Subjects will be randomly divided into blocks of random size 4 or 6 and stratified according to age (less than 12 years and greater / equal 12 years), performed through the RedCap platform, available at FMRPUSP. This process will be performed by laboratory staff who will provide the extracts and the researchers will not have access to the lists of patients in each group. As for blinding, the bottles with extract and placebo will be provided by the already coded laboratory, and the team will only be responsible for the delivery and storage of the same.
Table 1 - Weekly dose schedule Monday Wednesday Friday
- st week 1 drop 2 drops 4 drops
- nd week 6 drops 8 drops 8 drops
Table 2 - Monthly Dilution Schedule Dilution of mite extract
1st and 2nd weeks (1st month) 1: 1000000 v: v 3rd and 4th weeks (1st month) 1: 100000 v: v
1st and 2nd weeks (2nd month)1: 10000 v: v 3rd and 4th weeks (2nd month) 1:1000 v: v
1st and 2nd weeks (3rd month) 1: 100 v:v 3rd and 4th weeks (3rd month) 1:10 v:v 3rd to 18th month 1:10 v: v
Individuals will be the outpatient clinics of the Allergy and Dermatology Service of the HCFMRP-USP. All medical records and clinical and dermatological examination will be recorded in medical records, as well as clinical evaluation by SCORAD , quality of life questionnaire and personal scale of symptoms, being evaluated at the beginning of treatment, after two, three, six, nine, twelve, fifteen and eighteen months of evolution.
Serum levels of IgG4 specific mite for Der p 1 and Der p 2 will be determined by ImmunoCAP and evaluated at the beginning and the end of treatment. Interleukins 4, 5, 9, 10 13, 17, TNFα, TGFβ and interferon-γ will be performed in plasma in the beginning, with 9 months of evolution and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A total of 94 patients, 3 years of age or older, with clinical diagnosis of AD, without distinction of gender, ethnicity or social group, will be selected at HCFMRP-USP Allergy and Dermatology outpatient clinics. These patients will undergo clinical evaluation and laboratory tests, including blood count, total IgE, inhalant panel specific IgE, and / or immediate hypersensitivity skin tests, and mite allergen specific IgG4 (Der p 1 and Der p 2), before of the study. Patients in the treatment group will undergo sublingual allergen-specific immunotherapy with weekly and weekly doses of extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae mites (60% and 40% respectively), according to the predetermined schedule. Patients in the control group will be submitted to the same administration schedule, but with allergen extract diluent (doubly distilled water solution and glycerin).
| Arm | Type | Receives |
|---|---|---|
| Mite extract sublingual immunotherapy | Active comparator | Drug: Mite extract sublingual immunotherapy (SLIT)Use of mite extract sublingual immunotherapy (SLIT) with increasing weekly doses of extracts of mite Dermatophagoides pteronyssinus, as represented below: Weekly dose schedule Monday Wednesday Friday 1. st week 1 drop 2 drops 4 drops 2. nd week 6 drops 8 drops 8 drops Monthly Dilution Schedule Dilution of mite extract 1st and 2nd weeks (1st month) 1: 1000000 v: v 3rd and 4th weeks (1st month) 1: 100000 v: v 1st and 2nd weeks (2nd month)1: 10000 v: v 3rd and 4th weeks (2nd month) 1:1000 v: v 1st and 2nd weeks (3rd month) 1: 100 v:v 3rd and 4th weeks (3rd month) 1:10 v:v 3rd to 18th month 1:10 v: v |
| SLIT placebo | Placebo comparator | Other: PlaceboPatients in the control group will be submitted to the same administration schedule, but with allergen extract diluent (doubly distilled water solution and glycerin), as described below: Weekly dose schedule Monday Wednesday Friday 1. st week 1 drop 2 drops 4 drops 2. nd week 6 drops 8 drops 8 drops Intervention: Placebo - Immunotherapy allergen diluent |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of AD according to Hanifin and Rajka criteria;
- Age greater than or equal to 3 years;
- SCORAD equal to or greater than 15 points;
- Presence of skin tests and / or specific IgE positive for Dermatophagoides pteronyssinus and / or Dermatophagoides farinae;
Key exclusion criteria (1 listed)
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Mite extract sublingual immunotherapy (SLIT)Also: Allergen specific sublingual immunotherapy, Sublingual immunotherapy (SLIT)Administration of increasing weekly doses of extracts of mites Dermatophagoides pteronyssinus in the treatment group. | Drug | Mite extract sublingual immunotherapy |
| PlaceboAlso: Diluent of the allergenic extractPlacebo group will be submitted to administration of increasing weekly doses, but with diluent of the allergenic extract (doubly distilled water solution and glycerin). | Other | SLIT placebo |
Primary outcome
Decrease in Severity Scoring of Atopic Dermatitis (SCORAD)
Time frame: Measures at baseline and after 18 months
The SCORAD is calculated using the extent of the injury, intensity and subjective symptoms, the formula used for the calculation is A / 5 + 7B / 2 + C (A - extent B - intensity C-subjective symptoms). The extent can vary from zero to 100, applying the nine rule also used in large burned patients. The intensity varies from zero to 18, divided into six items, including erythema, edema, excoriation, lichenification, and dryness. Subjective symptoms range from zero to 30 evaluated by means of analog pruritus scale and sleep. The SCORAD severity rating is: 0-20 mild 20-40 moderate > 40 severe Based on our clinical experience, it was decided to consider as the main outcome a 15-point decrease in SCORAD,in any degree of severity, in 40% of subjects in the treatment group and 15% in the placebo group.
8 secondary outcomes
EASI (Eczema Area and Severity Index)
Time frame: 3, 6, 9, 12, 15 and 18 months
IGA (Investigator Global Assessment)
Time frame: 3,6,9,12,15 and 18 months
DLQI (Dermatology Life Quality Index)
Time frame: 3, 6, 9, 12,15 and 18 months
Analog Visual Scale of Symptoms
Time frame: 3, 6, 9, 12,15 and 18 months
Pruritus scale
Time frame: 3, 6, 9, 12, 15 and 18 months
IgG4 antibodies to mite allergens Der p 1, Der p 2 and Der p 10
Time frame: 0 and 18 months
Specific IgE antibodies to purified allergens and to Staphylococcal allerg
Time frame: 0 and 18 months
Type 2 and regulatory cytokines
Time frame: 0, 9 and 18 months
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 26 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Karla L Arruda, PhD study director
Faculdade de Medicina de Ribeirão Preto
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 Mite extract sublingual immunotherapy (SLIT) in people with Atopic Dermatitis and Effects of Immunotherapy, run by Casa Espirita Terra de Ismael 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 4 inclusion and 1 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 26 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
Decrease in Severity Scoring of Atopic Dermatitis (SCORAD) (time frame: Measures at baseline and after 18 months). 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 26 Aug 2020.