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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04829578
Other study ID # 20-AOIP-01
Secondary ID 2020-A03263-36
Status Completed
Phase N/A
First received
Last updated
Start date April 13, 2021
Est. completion date October 31, 2022

Study information

Verified date January 2024
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, for which there is no specific treatment. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.


Description:

Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, with significative impact on quality of life. At present, there is no specific treatment for CIP. Topical steroids are frequently used, with partial efficacy, and adverse effects. Hypnosis is a specific state of conscience. It differs from waking state, sleeping state, relaxation, or meditation. In this state, the person is highly responsive to suggestion. In medicine, hypnosis can be used to engage the internal resources of the person against unpleasant feelings. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 31, 2022
Est. primary completion date September 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Male or female of at least 18 years at screening - Diagnosis of chronic (at least 6 wks.) idiopathic pruritus - Pruritus Numeric Rating Scale > = 4 Exclusion Criteria: - Pruritus caused by a dermatological or a systemic conditions - Suicidal crisis, moderate, or severe - Psychosis (schizophrenia, persistent delusional disorder) - Bipolar disorder, not stabilized or decompensating - Personality disorder, decompensated

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hypnosis
Chronic idiopathic pruritus is treated by hypnosis

Locations

Country Name City State
France Chu de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Pruritus Numeric Rating Scale Assessment of the intensity of pruritis in Pruritus Numeric Rating Scal; the minimum and maximum values 0 to 10 Day 84
Secondary Change From Baseline in Pruritus Verbal Rating Scale Assessment of Pruritus by pruritus Verbal Rating Scale; the minimum and maximum values 0 to 4 Day 84
Secondary Change From Baseline in Sleeping Scale assessment in sleeping scale ; the minimum and maximum values 0 to 10 Day 84
Secondary Change From Baseline in DLQI scale assessment in DLQI scale; result between 0 to 30 Day 84
Secondary Change From Baseline in HAD scale assessment in HAD scale; result between 0 to 42 Day 84
Secondary Change From Baseline in usage of topical steroids assessment in usage of topical steroids Day 84
Secondary Evaluation of tolerance of hypnosis assessment of tolerance of hypnosis with report of adverse event Day 84
See also
  Status Clinical Trial Phase
Completed NCT03858634 - A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases Phase 2