Hôpital Saint-Louis
Paris, 75010, France
Location status: Recruiting
NCT Number: NCT05500794
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.
Interested in participating?
Request Info18 day and older
All sexes
Interventional
Not applicable
Paris, 75010, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OR Patient with atopic dermatitis:
Exclusion criteria
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:
Audio recordings and a manual are provided to support personal practice
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.
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.
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).
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).
Time frame: at 8 weeks
Time frame: at 16 weeks as compared to 8 weeks
Time frame: at 8 weeks
Time frame: at 16 weeks as compared to 8 weeks
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.
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.
Time frame: at 8 weeks
The maximal score of the SCORAD Index is 103.
Time frame: at 16 weeks as compared to 8 weeks
The maximal score of the SCORAD Index is 103.
Time frame: at 8 weeks
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
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Time frame: at 8 weeks
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
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Time frame: at 8 weeks
Serum stress markers will be CRP, cortisol, IL-6, IL-3, TNF-alpha and Adreno CorticoTropic Hormone
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
Contact information is provided by the study sponsor or research team.
Charles CASSIUS, Dr
CONTACT
Jérôme Lambert, Pr
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
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)
Acronym: MediDermIn
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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