Study of Alloknesia in Atopic Dermatitis

NCT06923202 | Recruiting

• 1 other identifier: 29BRC24.0355
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Atopic Dermatosis; Alloknesie

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• WI-NRS scale / Worst Itch Numeric Rating Scale

  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

  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

  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

  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

  At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atopic dermatitis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• Almirall, S.A.: collaborator

Study Sites (8)

CHU d'Angers

Angers, 49100, France

NOT YET RECRUITING

CHU de Brest

Brest, 29200, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85925, France

NOT YET RECRUITING

Groupe Hospitalier Bretagne Sud

Lorient, 56100, France

NOT YET RECRUITING

CHU de Nantes Hôtel-Dieu

Nantes, 44093, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35000, France

NOT YET RECRUITING

CHU de Tours

Tours, 37170, France

NOT YET RECRUITING

CH Bretagne Atlantique

Vannes, 56000, France

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 1798888 BACKGROUND

• 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.

  PMID: 8033378 BACKGROUND

• 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.

  PMID: 32936233 BACKGROUND

Central Study Contacts

Laurent MISERY, PUPH

CONTACT

02 98 22 33 15; laurent.misery@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• 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.

Locations

FR (8)