Effect of ion channel modification on symptoms in chronic eczema

In Dermatologist or Allergist diagnosed eczema, does use of multi-transient receptor potential modifying compound (MTRPMC) formulation plus placebo compared with no MTRPMC formulation plus placebo improve PO SCORAD

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000249853

Enrollment

Registered

2012-02-29

Start date

2013-07-01

Completion date

2013-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate the efficacy of naturally occurring edible compounds, that effect (block or activate) ion channels on nerves and some cells involved in inflammation, used topically to reduce the symptoms of chronic eczema. The eczema study will investigate patients with Dermatologist or Allergist diagnosed eczema who have significantly impaired quality of life and frequent need for moisturising creams and topical steroids. A randomized, controlled, crossover clinical trial will be undertaken with 2 sequential arms of treatment, 13 weeks duration each, and a 2 week washout period between each arm. One of the treatment arms will be active and one will be placebo. Patients will have a SCORAD completed at weeks 0 and 13 of each treatment arm with weekly PO-SCORAD measurements for self completion in between. Use of steroid cream, number of infected eczema episodes and quality of life measures will also be recorded. Patients will be recruited through specialist allergist and dermatology rooms.

Interventions

Arm 1: MTRPMC formulation (glycerine cream plus actives) Dose: Apply topically when required for itch/pain associated with eczema Arm 2: Placebo (glycerine cream) Dose: Apply topically when required for itch/pain associated with eczema Each intervention will be given for 13 weeks with a 2 week washout between each arm

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Dermatologist or Allergist diagnosed eczema severity moderate-severe Significant impairment of quality of life Need for frequent moisturising and topical steroids Must have indicated a willingness to enter the study Must have read and fully understood a study information form Must have had the opportunity to ask any questions prior to enrolment Must have signed study consent form

Exclusion criteria

Pregnant or likely to become pregnant People whose primary language is other than English (LOTE) People with a cognitive impairment, an intellectual disability or a mental illness Children and/or young people (ie. <18 years) Any history of reaction or intolerance to MTRPMC formulation

Outcome results