NCT05500794: MediDermIn

Meditation in Inflammatory Dermatosis

Recruiting now NA Last updated 19 September 2024

What this trial tests

NA trial testing MBSR (Mindfulness-Based Stress Reduction) in Atopic Dermatitis in 72 participants. Currently enrolling.

Timeline

15 November 2022

Primary endpoint
15 March 2026

15 May 2026

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	72
Start date	15 November 2022
Primary completion	15 March 2026
Estimated completion	15 May 2026
Sites	1 location across France

Drugs / interventions tested

• MBSR (Mindfulness-Based Stress Reduction)

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →
• Psoriasis — all drugs for Psoriasis →
• Pruritus — all drugs for Pruritus →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 Days and older, any sex, with Atopic Dermatitis or Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.