Meditation in Inflammatory Dermatosis (MediDermIn)

September 13, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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)

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. The 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MBSR (Mindfulness-Based Stress Reduction) group
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.
Other: MBSR (Mindfulness-Based Stress Reduction)

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pruritus assessed by Visual Analogue Scale (VAS)
Time Frame: at 8 weeks
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pruritus assessed by Visual Analogue Scale (VAS)
Time Frame: at 16 weeks
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
at 16 weeks
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
Time Frame: at 8 weeks
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).
at 8 weeks
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
Time Frame: at 16 weeks as compared to 8 weeks
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).
at 16 weeks as compared to 8 weeks
Number of dermatocorticoides tubes
Time Frame: at 8 weeks
at 8 weeks
Number of dermatocorticoides tubes
Time Frame: at 16 weeks as compared to 8 weeks
at 16 weeks as compared to 8 weeks
Number of scratches per day (including nights)
Time Frame: at 8 weeks
at 8 weeks
Number of scratches per day (including nights)
Time Frame: at 16 weeks as compared to 8 weeks
at 16 weeks as compared to 8 weeks
Psorasis Area and severity index (PASI Index) for psoriasis group
Time Frame: at 8 weeks
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.
at 8 weeks
Psorasis Area and severity index (PASI Index) for psoriasis group
Time Frame: at 16 weeks as compared to 8 weeks
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.
at 16 weeks as compared to 8 weeks
SCORAD Index for atopic dermatitis
Time Frame: at 8 weeks
The maximal score of the SCORAD Index is 103.
at 8 weeks
SCORAD Index for atopic dermatitis
Time Frame: at 16 weeks as compared to 8 weeks
The maximal score of the SCORAD Index is 103.
at 16 weeks as compared to 8 weeks
Stress evaluation assessed by Perceived Stress Scale
Time Frame: at 8 weeks
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
at 8 weeks
Stress evaluation assessed by Perceived Stress Scale
Time Frame: at 16 weeks as compared to 8 weeks
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
at 16 weeks as compared to 8 weeks
Quantification of inflammatory stress markers in saliva
Time Frame: at 8 weeks
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
at 8 weeks
Quantification of inflammatory stress markers in saliva
Time Frame: at 16 weeks as compared to 8 weeks
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
at 16 weeks as compared to 8 weeks
Quantification of inflammatory stress markers in serum
Time Frame: at 8 weeks
Serum stress markers will be CRP, cortisol, IL-6, IL-3, TNF-alpha and Adreno CorticoTropic Hormone
at 8 weeks
Quantification of inflammatory stress markers in serum
Time Frame: at 16 weeks as compared to 8 weeks
Serum stress markers will be CRP, cortisol, IL-6, IL-31,TNF-alpha and Adreno CorticoTropic Hormone
at 16 weeks as compared to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP211191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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