Completed

RAAPEfficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Food Hypersensitivity+1

+ Hypersensitivity

+ Hypersensitivity, Immediate

Over 10 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2016
See protocol details

Summary

Principal SponsorMichel Bouvier
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2016

Actual date on which the first participant was enrolled.

The aim of this study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017. Methods : Patients were included during the first consultation, UR was performed with RGA in day hospital performed in two institutions, the Charcot clinic and the polyclinic of Beaujolais. Starting with 1 gram (g) of food, then by regularly doubling dose from 2g to 128g, to reach a 255g cumulative dose in a 3 hour period. During the the post hospitalization period, patients back home had to eat ½ RGA a day during one month, then 1 RGA a day during one month, together with other rosacea fruits resumption at the end of the 5th week if UR were performed between April 15th and July 15th. A synthesis consultation was made at two months and a telephone interview at one year.

Official TitleEfficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients
NCT04116580
Principal SponsorMichel Bouvier
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 10 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Food HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System Diseases

Criteria

3 inclusion criteria required to participate
No longer eat raw rosacea for at least 6 months due to oral allergic syndrome
With allergic rhinitis or asthma due to betulaceae pollen (SPT+ and/or IgE + to Bet v 1 > 0,10 kUA/L)
With reduced quality of life
5 exclusion criteria prevent from participating
With severe allergic reaction to rosacea (>Grade 3 according to Ring and Messmer's classification)
Pregnant woman
Uncontrolled asthma (FEV1 < 70%)
Immunosuppressed patient or having malignant disease, current infectious disease, or serious cardiovascular disease
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

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CompletedNo study centers