Study of Alloknesia in Atopic Dermatitis (ALLOKNESIE)

May 29, 2026 updated by: University Hospital, Brest
Alloknesia is defined as pruritus (= itching) triggered by light mechanical stimuli, which are responsible for the perception of light touch under physiological conditions, but which are perceived as pruritic under pathological conditions. Alloknesia occurs mainly in the context of chronic pruritus. Consequently, patients suffering from chronic pruritus frequently perceive light touch sensations as pruritic, which can be particularly unpleasant and alter human interactions and quality of life on a daily basis. However, the epidemiology and burden of alloknesia have never been studied, whatever the cause of chronic pruritus.Atopic dermatitis is one of the main diseases causing chronic itching, and patients frequently complain of alloknesia. In this study, the investigators are studying the frequency of alloknesia in patients with atopic dermatitis and measuring the consequences of alloknesia in these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France, 49100
        • Recruiting
        • CHU d'Angers
        • Contact:
          • Nina SIGG, Doctor
      • Brest, France, 29200
      • La Roche-sur-Yon, France, 85925
        • Recruiting
        • CHD Vendee
        • Contact:
          • Romain GABEFF, Doctor
      • Lorient, France, 56100
        • Recruiting
        • Groupe Hospitalier Bretagne Sud
        • Contact:
          • Caroline JACOBZONE LEVEQUE, Doctor
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes Hôtel-Dieu
        • Contact:
          • Sebastien BARBAROT, Professor
      • Rennes, France, 35000
        • Recruiting
        • CHU de Rennes
        • Contact:
          • Catherine DROITCOURT, Doctor
      • Tours, France, 37170
        • Recruiting
        • Chu De Tours
        • Contact:
          • Mahtab SAMINI, Professor
      • Vannes, France, 56000
        • Recruiting
        • CH Bretagne Atlantique
        • Contact:
          • Marine ROBERT, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with atopic dermatitis

Description

Inclusion Criteria:

  • Age ≥18 years
  • No opposition from the patient
  • Diagnosis of atopic dermatitis more than 6 months old

Exclusion Criteria:

  • Patients who are physically or mentally unable to complete the questionnaires.
  • Patients on systemic treatment for 1 month or more
  • Refusal to participate
  • Patients under legal protection (guardianship, curatorship)
  • Patients under court protection

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with atopic dermatitis
Patients will take part in the study on a single occasion, during which they will complete the various questionnaires (Alloknesia diagnostic questionnaire, WI-NRS scale, ItchyQol questionnaire, DLQI questionnaire, HADS questionnaire, PUSH-D questionnaire, PSS (Perceived Stress Scale), Epworth questionnaire, ISS questionnaire). There will be no follow-up.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alloknesia diagnostic questionnaire
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
The questionnaire consists of a single question: 'Can the touch of your skin by clothing, air movements or the light touch of an object or another person trigger itching?
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WI-NRS scale / Worst Itch Numeric Rating Scale
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Digital pruritus scale, measuring the worst daily itching intensity 0 to 10. 0: no itching 10: worst itch imaginable
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
ItchyQoL questionnaire / quality-of life instrument for pruritus
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Quality-of life instrument for pruritus Itch-related quality of life 0 to 110
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
DLQI questionnaire / Dermatology Life Quality Index
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Skin-related quality of life 0 to 30
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
HADS questionnaire / Hospital Anxiety and Depression Scale
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.

The HAD scale is an instrument for screening for anxiety and depressive disorders.

0 to 21
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
PUSH-D questionnaire / Patient Unique Stigmatization Holistic tool in dermatology
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.

PUSH-D allows a comprehensive view of the degree of stigmatization in visible skin disorders.

0 to 68
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Stress perçu : PSS / Perceived Stress Scale
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
The PSS (Perceived Stress Scale) is a scale for measuring perceived stress. 0 to 40
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Epworth questionnaire / sleepiness scale
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.

The Epworth Test is a self-administered questionnaire that assesses subjective sleepiness and fatigue.

0 to 21
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
ISS questionnaire / Sexual Satisfaction Index
Time Frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Satisfaction with sexual relations 25 to 175
At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Almirall, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29BRC24.0355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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