Atopic DermatosisALLOKNESIENCT06923202
Study of Alloknesia in Atopic Dermatitis
An observational study of Atopic Dermatosis and Alloknesie, run by University Hospital, Brest at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatosis, Alloknesie
- How many people
- 160 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Feb 2026to 10 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atopic dermatitis
Who may be able to join
- Age ≥18 years
- No opposition from the patient
- Diagnosis of atopic dermatitis more than 6 months old
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU d'Angers
Angers, 49100
Nina SIGG, Doctor
- Recruiting
CHU de Brest
Brest, 29200
Laurent MISERY, Professor, laurent.misery@chu-brest.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
Romain GABEFF, Doctor
- Recruiting
Groupe Hospitalier Bretagne Sud
Lorient, 56100
Caroline JACOBZONE LEVEQUE, Doctor
- Recruiting
CHU de Nantes Hôtel-Dieu
Nantes, 44093
Sebastien BARBAROT, Professor
- Recruiting
CHU de Rennes
Rennes, 35000
Catherine DROITCOURT, Doctor
- Recruiting
CHU de Tours
Tours, 37170
Mahtab SAMINI, Professor
- Recruiting
CH Bretagne Atlantique
Vannes, 56000
Marine ROBERT, Doctor
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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
Digital pruritus scale, measuring the worst daily itching intensity 0 to 10. 0: no itching 10: worst itch imaginable
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start10 Feb 2026
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Almirall, S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923202
- Sponsor's protocol ID
- 29BRC24.0355
- Acronym
- ALLOKNESIE
- Status last verified
- May 2026
- First submitted
- 4 Apr 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
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.
PubMed 1798888Finlay 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.
PubMed 8033378Kimel 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.
PubMed 32936233
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Alloknesia in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06923202
- Acronym / sponsor ID
- ALLOKNESIE / 29BRC24.0355
- Conditions
- Atopic Dermatosis, Alloknesie
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Almirall, S.A.
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atopic dermatitis
Key inclusion criteria (3 listed)
- Age ≥18 years
- No opposition from the patient
- Diagnosis of atopic dermatitis more than 6 months old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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?
8 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 1798888Johns 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.
- Background: PubMed 8033378Finlay 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.
- Background: PubMed 32936233Kimel 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatosis and Alloknesie, run by University Hospital, Brest at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent MISERY, PUPH (02 98 22 33 15, laurent.misery@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06923202, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.