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Meditation in Inflammatory Dermatosis (MediDermIn)

Primary Purpose

Atopic Dermatitis, Psoriasis, Pruritus

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MBSR (Mindfulness-Based Stress Reduction)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Dermatitis focused on measuring Mindfulness, Based Stress Reduction, Psoriasis, Atopic Dermatitis, Pruritus, Inflammatory Cytokines

Eligibility Criteria

18 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient aged 18 years old or older
  • With health insurance coverage
  • Significant pruritus defined by a Visual Analogical Scale (VAS) pruritus ≥ 4
  • Patient with plaque psoriasis

    • Without joint involvement
    • Mild to moderate severity (PASI>10)
    • DLQI > 10

OR Patient with atopic dermatitis:

  • Mild to moderate severity (SCORAD>10)
  • DLQI > 10
  • Diagnosis according to Hanifin and Raijka criteria

    • Patient in a stable psychological state
    • French langage spoken

Exclusion Criteria :

  • Current systemic treatment or treatment discontinued within the last month
  • Psychiatric illnesses diagnosed according to the DSM-5 or ICD-10 international criteria of psychotic disorder, severe anxiety disorder, depressive disorder with a current depressive episode of severe intensity, bipolar disorder with a current depressive or manic episode
  • Taking psychotropic or neuroleptic treatments
  • Participation in another interventional research study or being in the exclusion period at the end of a previous study, if applicable
  • Patient under AME

Sites / Locations

  • Hôpital Saint-Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBSR (Mindfulness-Based Stress Reduction) group

Standard group

Arm Description

MBSR (Mindfulness-Based Stress reduction) program : 1 weekly session of 2 hours and a half for 8 weeks, (first and last session: 3 hours) and an optional day of intensive practice of 6 hours, supervised by an MBSR instructor.

No intervention in this group which will be followed according to the standard care

Outcomes

Primary Outcome Measures

Pruritus assessed by Visual Analogue Scale (VAS)
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.

Secondary Outcome Measures

Pruritus assessed by Visual Analogue Scale (VAS)
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
The 5-D itch scale is a multidimensional questionnaire. The scores of each of the domains are achieved separately and then summed together : total 5-D score can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
The 5-D itch scale is a multidimensional questionnaire. The scores of each of the domains are achieved separately and then summed together : total 5-D score can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
Number of dermatocorticoides tubes
Number of dermatocorticoides tubes
Number of scratches per day (including nights)
Number of scratches per day (including nights)
Psorasis Area and severity index (PASI Index) for psoriasis group
This score takes into account the affected skin surface, the degree of redness, the thickening of the skin and the scaling. Its ranges from 0 to 72.The higher the number, the more severe the psoriasis.
Psorasis Area and severity index (PASI Index) for psoriasis group
This score takes into account the affected skin surface, the degree of redness, the thickening of the skin and the scaling. Its ranges from 0 to 72.The higher the number, the more severe the psoriasis.
SCORAD Index for atopic dermatitis
The maximal score of the SCORAD Index is 103.
SCORAD Index for atopic dermatitis
The maximal score of the SCORAD Index is 103.
Stress evaluation assessed by Perceived Stress Scale
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Stress evaluation assessed by Perceived Stress Scale
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Quantification of inflammatory stress markers in saliva
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Quantification of inflammatory stress markers in saliva
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Quantification of inflammatory stress markers in serum
Serum stress markers will be CRP, cortisol, IL-6, IL-3, TNF-alpha and Adreno CorticoTropic Hormone
Quantification of inflammatory stress markers in serum
Serum stress markers will be CRP, cortisol, IL-6, IL-31,TNF-alpha and Adreno CorticoTropic Hormone

Full Information

First Posted
August 11, 2022
Last Updated
August 11, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05500794
Brief Title
Meditation in Inflammatory Dermatosis
Acronym
MediDermIn
Official Title
Evaluation of the Therapeutic Efficacy of a Mindfulness-Based Stress Reduction (MBSR) Program as an Adjuvant Therapy in Patients With Moderate Pruritic Inflammatory Dermatosis (Psoriasis or Atopic Dermatitis)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Psoriasis and atopic dermatitis are multifactorial inflammatory dermatoses, with a very high prevalence, reaching more than 120 million patients in the world. Although the physiopathological mechanisms are not yet clearly defined, these inflammatory dermatoses involve an interaction between the immune system and the epidermal cells, severe skin inflammation and often very intense pruritus. The objectives of an effective management should be to treat lesions in order to reduce them, but also to reduce itching and allow the patients to accept and cope with their pathology, without neglecting an improvement in the "Dermatology Life Quality Index" (DLQI) and in the psychological state, sometimes depressive, of the patient. Itching is defined as "a feeling that needs to be scratched urgently" and can cause significant distress along with pain. It severely impacts the quality of life and the quality of sleep. Chronic itching is associated with increased stress, anxiety, and other mood disorders. In turn, stress and anxiety exacerbate the itching, leading to a vicious cycle of pruritus - scratching that affects patient behavior (excessive scratching) and worsens disease prognosis and quality of life. Much research over the past few decades has demonstrated the effect of mindfulness meditation on emotional and cognitive responsiveness, cognitive flexibility, rumination, self-compassion and mindfulness, but also on acute pain, anxiety, stress, depression, cardiovascular disease, eating disorders, cancer and cognitive loss with age. Several studies have shown the impact of mindfulness on brain function and immunity, with evidence for the association between mindfulness and changes in the levels of markers characteristic of immune system activity and inflammation, known to be increased in psoriasis or atopic dermatitis. Our objective is to evaluate the effect of mental training in the regulation of stress and emotions through mindfulness meditation in patients with moderate, itchy atopic dermatitis or psoriasis, not treated with systemic agents (e.g.: biotherapies). This project is based on the premise that mental training in the regulation of stress and emotions through meditation would reduce the effects of the infernal itch-scratch cycle, alleviating pruritus, thus improving the well-being and mental health of patients while reducing their inflammatory skin lesions and limiting the appearance of new lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Psoriasis, Pruritus
Keywords
Mindfulness, Based Stress Reduction, Psoriasis, Atopic Dermatitis, Pruritus, Inflammatory Cytokines

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBSR (Mindfulness-Based Stress Reduction) group
Arm Type
Experimental
Arm Description
MBSR (Mindfulness-Based Stress reduction) program : 1 weekly session of 2 hours and a half for 8 weeks, (first and last session: 3 hours) and an optional day of intensive practice of 6 hours, supervised by an MBSR instructor.
Arm Title
Standard group
Arm Type
No Intervention
Arm Description
No intervention in this group which will be followed according to the standard care
Intervention Type
Other
Intervention Name(s)
MBSR (Mindfulness-Based Stress Reduction)
Intervention Description
MBSR (Mindfulness-Based Stress reduction) program : 1 weekly session of 2 hours and a half for 8 weeks, (first and last session: 3 hours) and an optional day of intensive practice of 6 hours, supervised by an MBSR instructor. In each weekly session, the instructor creates a supportive environment in which: Guided meditation practices; Mindfulness stretching and yoga; Reflection and group discussion periods aimed at promoting mindfulness in daily life; Practice instructions and opportunity to ask questions; Instructions for home practice. Audio recordings and a manual are provided to support personal practice. Audio recordings and a manual are provided to support personal practice
Primary Outcome Measure Information:
Title
Pruritus assessed by Visual Analogue Scale (VAS)
Description
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
Time Frame
at 8 weeks
Secondary Outcome Measure Information:
Title
Pruritus assessed by Visual Analogue Scale (VAS)
Description
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
Time Frame
at 16 weeks
Title
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
Description
The 5-D itch scale is a multidimensional questionnaire. The scores of each of the domains are achieved separately and then summed together : total 5-D score can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
Time Frame
at 8 weeks
Title
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
Description
The 5-D itch scale is a multidimensional questionnaire. The scores of each of the domains are achieved separately and then summed together : total 5-D score can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
Time Frame
at 16 weeks as compared to 8 weeks
Title
Number of dermatocorticoides tubes
Time Frame
at 8 weeks
Title
Number of dermatocorticoides tubes
Time Frame
at 16 weeks as compared to 8 weeks
Title
Number of scratches per day (including nights)
Time Frame
at 8 weeks
Title
Number of scratches per day (including nights)
Time Frame
at 16 weeks as compared to 8 weeks
Title
Psorasis Area and severity index (PASI Index) for psoriasis group
Description
This score takes into account the affected skin surface, the degree of redness, the thickening of the skin and the scaling. Its ranges from 0 to 72.The higher the number, the more severe the psoriasis.
Time Frame
at 8 weeks
Title
Psorasis Area and severity index (PASI Index) for psoriasis group
Description
This score takes into account the affected skin surface, the degree of redness, the thickening of the skin and the scaling. Its ranges from 0 to 72.The higher the number, the more severe the psoriasis.
Time Frame
at 16 weeks as compared to 8 weeks
Title
SCORAD Index for atopic dermatitis
Description
The maximal score of the SCORAD Index is 103.
Time Frame
at 8 weeks
Title
SCORAD Index for atopic dermatitis
Description
The maximal score of the SCORAD Index is 103.
Time Frame
at 16 weeks as compared to 8 weeks
Title
Stress evaluation assessed by Perceived Stress Scale
Description
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Time Frame
at 8 weeks
Title
Stress evaluation assessed by Perceived Stress Scale
Description
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Time Frame
at 16 weeks as compared to 8 weeks
Title
Quantification of inflammatory stress markers in saliva
Description
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Time Frame
at 8 weeks
Title
Quantification of inflammatory stress markers in saliva
Description
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Time Frame
at 16 weeks as compared to 8 weeks
Title
Quantification of inflammatory stress markers in serum
Description
Serum stress markers will be CRP, cortisol, IL-6, IL-3, TNF-alpha and Adreno CorticoTropic Hormone
Time Frame
at 8 weeks
Title
Quantification of inflammatory stress markers in serum
Description
Serum stress markers will be CRP, cortisol, IL-6, IL-31,TNF-alpha and Adreno CorticoTropic Hormone
Time Frame
at 16 weeks as compared to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 18 years old or older With health insurance coverage Significant pruritus defined by a Visual Analogical Scale (VAS) pruritus ≥ 4 Patient with plaque psoriasis Without joint involvement Mild to moderate severity (PASI>10) DLQI > 10 OR Patient with atopic dermatitis: Mild to moderate severity (SCORAD>10) DLQI > 10 Diagnosis according to Hanifin and Raijka criteria Patient in a stable psychological state French langage spoken Exclusion Criteria : Current systemic treatment or treatment discontinued within the last month Psychiatric illnesses diagnosed according to the DSM-5 or ICD-10 international criteria of psychotic disorder, severe anxiety disorder, depressive disorder with a current depressive episode of severe intensity, bipolar disorder with a current depressive or manic episode Taking psychotropic or neuroleptic treatments Participation in another interventional research study or being in the exclusion period at the end of a previous study, if applicable Patient under AME
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles CASSIUS
Phone
+331.42.38.50.49
Email
charles.cassius@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu Resche-Rigon
Phone
+33142499742
Email
matthieu.resche-rigon@u-paris.fr
Facility Information:
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles CASSIUS
Phone
+331.42.38.50.49
Email
charles.cassius@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Meditation in Inflammatory Dermatosis

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