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Trial registered on ANZCTR


Registration number
ACTRN12619000231145
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
18/02/2019
Date last updated
11/02/2020
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of RadianiX™ as a skin health supplement.
Scientific title
A randomized, double-blind, placebo-controlled, multiple-dose study of the efficacy and safety of a sublingual glutathione wafer (RadianiX™) as a therapeutic skin health supplement.
Secondary ID [1] 297293 0
RDX-001
Universal Trial Number (UTN)
U1111-1227-9944
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Appearance 311376 0
Condition category
Condition code
Skin 310013 310013 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to 1 of 3 treatment groups:
Cohort 1 will receive 100mg RadianiX™ dissolved under the tongue twice daily for 12 weeks. Cohort 2 will receive 200 mg RadianiX™ dissolved under the tongue twice daily for 12 weeks.
Cohort 3 will receive Placebo wafers dissolved under the tongue twice daily for 12 weeks.
Participants will complete a diary each time the medication is taken and will bring their diary and their study medication supply (including empty packaging) to clinic visits for review.

Intervention code [1] 313572 0
Treatment: Drugs
Comparator / control treatment
Cohort 3 will receive a microcrystalline cellulose placebo wafer to be dissolved under the tongue twice daily for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 318960 0
To determine the change in skin melanin index as measured by the Mexameter® MX 18 (Courage + Khazaka electronic GmbH). The Mexameter® probe emits 3 specific light wavelengths. A receiver measures the reflection from the skin.


Timepoint [1] 318960 0
Days 0, 28, 56, 70 and 84.
Primary outcome [2] 319030 0
To determine the change in skin colourimetry as measured by the Skin-Colorimeter CL 400 (Courage + Khazaka electronic GmbH). The probe sends out white LED light and the light reflected from the skin is measured in the probe.
Timepoint [2] 319030 0
Days 0, 28, 56, 70 and 84.
Primary outcome [3] 319031 0
To determine the change in skin luminosity as measured by the Skin-Glossymeter GL 200 (Courage + Khazaka electronic GmbH), a tool used to measure gloss on surfaces, especially skin. The measurement is based on light reflection.
Timepoint [3] 319031 0
Days 0, 28, 56, 70 and 84.
Secondary outcome [1] 366982 0
(Primary) To determine the change in erythema score as measured by the Mexameter® MX 18 (Courage + Khazaka electronic GmbH). The Mexameter® probe emits 3 specific light wavelengths. A receiver measures the reflection from the skin.
Timepoint [1] 366982 0
Days 0, 28, 56, 70 and 84.

Eligibility
Key inclusion criteria
Fitzpatrick skin type IV or V
Good general health
Minimum age
30 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of glutathione products within the last 1 month.
Personal history of skin cancer.
Inappropriate for measurement in the skin area.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301855 0
Commercial sector/Industry
Name [1] 301855 0
iX Biopharma Pty Ltd
Address [1] 301855 0
24 Augusta Street
Willetton, WA 6155
Australia
Country [1] 301855 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
iX Biopharma Pty Ltd
Address
24 Augusta Street
Willetton, WA 6155
Australia
Country
Australia
Secondary sponsor category [1] 301600 0
None
Name [1] 301600 0
Address [1] 301600 0
Country [1] 301600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302551 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 302551 0
129 Glen Osmond Road
Eastwood, SA 5063
Ethics committee country [1] 302551 0
Australia
Date submitted for ethics approval [1] 302551 0
06/02/2019
Approval date [1] 302551 0
28/10/2019
Ethics approval number [1] 302551 0

Summary
Brief summary
This study aims to demonstrate the safety and effectiveness of a wafer containing glutathione (an anti-oxidant) as a therapeutic skin health supplement. The treatment involves taking glutathione wafer under the tongue 2 times daily for 12 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90618 0
Dr Joanna Grimsdale
Address 90618 0
Oztrials Clinical Research
Suite 1, 56-56A Thompson Street
Drummoyne NSW 2047

Country 90618 0
Australia
Phone 90618 0
+61 02 9719 3852
Fax 90618 0
Email 90618 0
trials@oztrials.com
Contact person for public queries
Name 90619 0
Ms Emanuela Elia
Address 90619 0
Oztrials Clinical Research
Suite 1, 56-56A Thompson Street
Drummoyne NSW 2047
Country 90619 0
Australia
Phone 90619 0
+61 02 9719 3852
Fax 90619 0
Email 90619 0
trials@oztrials.com
Contact person for scientific queries
Name 90620 0
Ms Emanuela Elia
Address 90620 0
Oztrials Clinical Research
Suite 1, 56-56A Thompson Street
Drummoyne NSW 2047
Country 90620 0
Australia
Phone 90620 0
+61 02 9719 3852
Fax 90620 0
Email 90620 0
trials@oztrials.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results