Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000249853
Ethics application status
Approved
Date submitted
18/02/2012
Date registered
29/02/2012
Date last updated
18/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of ion channel modification on symptoms in chronic eczema
Scientific title
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
Secondary ID [1] 279965 0
Nil
Universal Trial Number (UTN)
U1111-1126-6120
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatologist or allergist diagnosed eczema 285882 0
Condition category
Condition code
Skin 286072 286072 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 284300 0
Treatment: Other
Comparator / control treatment
Glycerine cream
Control group
Active

Outcomes
Primary outcome [1] 286551 0
PO SCORAD(patient orientated scoring atopic dermatitis) index
Timepoint [1] 286551 0
at end of weeks 1-13 for each arm of treatment
Primary outcome [2] 286552 0
SCORAD (scoring atopic dermatitis) index
Timepoint [2] 286552 0
at time 0 and end of week 13 for each arm of treatment
Secondary outcome [1] 296143 0
amount of steroid used measured in grams - measurements made by counting number of full tubes of steroid used and adding their weights, plus using measuring scales to weigh any part used tubes to determine weight used.
Timepoint [1] 296143 0
at time 0 and end of week 13 for each arm of treatment
Secondary outcome [2] 296144 0
infected eczema and need for antibiotics
Timepoint [2] 296144 0
at end of each 13 week treatment arm, record number of episodes during the 13 week period.
Secondary outcome [3] 296145 0
quality of life reflective itch score; measured using the The Dermatology Life Quality Index (DLQI) reproduced with permission (from Professor Andrew Finlay) http://www.dermatology.org.uk/quality/quality-life.html
Timepoint [3] 296145 0
At weekly intervals during treatment arms

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled for both arms of treatment with a treatment free period of 2 weeks (washout) in between each arm. Allocation will be concealed using a randomisation generator via the internet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
http://www.randomization.com/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2012
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
30/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284733 0
Self funded/Unfunded
Name [1] 284733 0
Peter Smith - Testudo Research Pty Ltd
Country [1] 284733 0
Australia
Primary sponsor type
Individual
Name
Peter Smith
Address
Pacific Private Clinic
Suite 4. Level 5, 123 Nerang Street
Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 283629 0
None
Name [1] 283629 0
Address [1] 283629 0
Country [1] 283629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286741 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 286741 0
Office for research
Griffith University
G39 3.56
Gold Coast Campus
Parklands Drive
Southport, Qld 4215
Ethics committee country [1] 286741 0
Australia
Date submitted for ethics approval [1] 286741 0
20/02/2012
Approval date [1] 286741 0
01/07/2013
Ethics approval number [1] 286741 0

Summary
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.
Trial website
Trial related presentations / publications
None yet. We found a 40% reduction in itch scores.
Public notes

Contacts
Principal investigator
Name 33797 0
Prof Pete smith
Address 33797 0
QLD Allergy Services
17/123 Nerang St
Southport Qld 4215
Country 33797 0
Australia
Phone 33797 0
+61755915744
Fax 33797 0
Email 33797 0
admin@qldallergy.com
Contact person for public queries
Name 17044 0
Dr Pete Smith
Address 17044 0
QLD Allergy Services
17/123 Nerang St
Southport Qld 4215
Country 17044 0
Australia
Phone 17044 0
+61755915744
Fax 17044 0
Email 17044 0
admin@qldallergy.com
Contact person for scientific queries
Name 7972 0
Prof Peter Smith
Address 7972 0
QLD Allergy Services
17/123 Nerang St
Southport Qld 4215
Country 7972 0
Australia
Phone 7972 0
+61755915744
Fax 7972 0
Email 7972 0
admin@qldallergy.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.