Study of Alloknesia in Atopic Dermatitis (ALLOKNESIE)

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: Recruiting
• Conditions: Atopic Dermatosis; Alloknesie

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Laurent MISERY, PUPH; Phone Number: 02 98 22 33 15; Email: laurent.misery@chu-brest.fr

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • CHU d'Angers
    • Contact: Nina SIGG, Doctor
  • Brest, France, 29200
    • Recruiting
    • CHU de Brest
    • Contact: Laurent MISERY, Professor; Email: laurent.misery@chu-brest.fr
  • 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Alloknesia diagnostic questionnaire	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

Outcome Measure	Measure Description	Time Frame
WI-NRS scale / Worst Itch Numeric Rating Scale	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	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	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	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	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	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	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	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

• Sponsor: University Hospital, Brest
• Collaborators: Almirall, S.A.

Publications and helpful links

General Publications

• Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
• Kimel M, Zeidler C, Kwon P, Revicki D, Stander S. Validation of Psychometric Properties of the Itch Numeric Rating Scale for Pruritus Associated With Prurigo Nodularis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1354-1358. doi: 10.1001/jamadermatol.2020.3071.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 10, 2027

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Skin Diseases
• Other Study ID 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