Trial Review

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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
21/03/2022
Date data sharing statement initially provided
18/02/2019
Date results information initially provided
15/10/2021
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
30/01/2020
Actual
15/03/2021
Date of last participant enrolment
Anticipated
Actual
28/06/2021
Date of last data collection
Anticipated
30/11/2021
Actual
30/11/2021
Sample size
Target
48
Accrual to date
Final
48
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
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
[email protected]
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
[email protected]
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
[email protected]

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 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.