Clinical trial NCT06923202: Study of Alloknesia in Atopic Dermatitis
Official title: Study of Alloknesia in Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atopic Dermatosis
Alloknesie
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Almirall, S.A.
First posted: 2025-04-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atopic dermatitis

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, we aim to investigate the frequency of alloknesia in patients with atopic dermatitis and to measure the consequences of alloknesia in these patients.


Eligibility criteria: 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

Primary outcomes:
measure: Alloknesia diagnostic questionnaire
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Secondary outcomes:
measure: WI-NRS scale
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
measure: ItchyQoL questionnaire
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
measure: DLQI (Dermatology Life Quality Index) questionnaire
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
measure: HADS (Hospital Anxiety and Depression Scale) questionnaire
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
measure: Stigmatisation : PUSH-D questionnaire
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
measure: Stress perçu : PSS (Perceived Stress Scale)
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
measure: Insomnia: Epworth questionnaire
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
measure: ISS (Sexual Satisfaction Index) questionnaire
timeFrame: Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.