Effect of Sublingual Immunotherapy in Patients With Atopic Dermatitis

NCT03388866 | Completed Phase 4 DMC

• 1 other identifier: SLIT_AD1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Atopic Dermatitis; Effects of Immunotherapy

Keywords

inhaled aeroallergens; eczema; pruritus; life quality; immunotheraphy; atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Measures at baseline and after 18 months

Secondary Outcomes (8)

• EASI (Eczema Area and Severity Index)

  3, 6, 9, 12, 15 and 18 months

• IGA (Investigator Global Assessment)

  3,6,9,12,15 and 18 months

• DLQI (Dermatology Life Quality Index)

  3, 6, 9, 12,15 and 18 months

• Analog Visual Scale of Symptoms

  3, 6, 9, 12,15 and 18 months

• Pruritus scale

  3, 6, 9, 12, 15 and 18 months

Study Arms (2)

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

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

Other: Placebo

Interventions

Mite extract sublingual immunotherapy (SLIT) DRUG

Administration of increasing weekly doses of extracts of mites Dermatophagoides pteronyssinus in the treatment group.

Also known as: Allergen specific sublingual immunotherapy, Sublingual immunotherapy (SLIT)

Mite extract sublingual immunotherapy

Placebo OTHER

Placebo group will be submitted to administration of increasing weekly doses, but with diluent of the allergenic extract (doubly distilled water solution and glycerin).

Also known as: Diluent of the allergenic extract

SLIT placebo

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Pregnancy or breastfeeding;

Sponsors & Collaborators

• Casa Espirita Terra de Ismael: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Karla L Arruda, PhD

  Faculdade de Medicina de Ribeirão Preto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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) and severity (SCORAD less than 50 and greater / equal 50)\*\*, 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. \*\* Initial SCORAD was not part of the stratification because it was part of the primary outcome variable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical School of Ribeirão Preto - University of São Paulo Children´s Hospital

Model Details: 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).

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: January 3, 2018
• Study Start: May 2, 2018
• Primary Completion: October 30, 2019
• Study Completion: June 26, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

BR (1)