Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000974303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
10/02/2026
Date registered
Help: Date registered
7/08/2026
Date last updated
Help: Date last updated
22/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Consumer expeRiencE of suPpLemEnt on agiNg sIgns and Skin Hydration
Scientific title
Consumer expeRiencE of suPpLemEnt on agiNg sIgns and Skin Hydration
Additional trial identifiers [1] 316496 0
None
Universal Trial Number (UTN)
Trial acronym
REPLENISH
Related trial records

Health condition
Health condition(s) studied:
Skin hydration 340630 0
Condition category
Condition code
Skin 336822 336822 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Swisse Nutra Cellular Skin Hydration capsule (ARTG ID: 486190) is an over the counter, non-prescription supplement, that contains 35mg of Ceramosides Oil Neutra, 100mg of sodium hyaluronate, 1.25mg of Vitamin B5 and 50mg of Vitamin C.

The product presentation is a soft capsule, route of administration is oral, and frequency of intake two capsules once daily, in the evening for the duration of the study (8 weeks). Adherence to the intervention will be monitored using two approaches: (1) participants will complete self-reported adherence questions at Week 4 and Week 8 as part of the study questionnaires, and (2) participants will be asked to return their used and unused vials at the Week 4 and Week 8 visits.
Intervention code [1] 333163 0
Treatment: Other
Description of the comparator or control
Participants will be randomly assigned in 1:1 allocation to either a treatment or placebo group, The placebo tablet contains no active ingredients. The placebo consists of an inert fill of microcrystalline cellulose. The placebo contains no active ingredients and no known allergens.
Control group
Placebo

Outcomes
Primary outcome [1] 344341 0
Mean change in skin hydration
Timepoint [1] 344341 0
Baseline, 4 weeks following treatment and 8 weeks following treatment
Secondary outcome [1] 457566 0
Mean change in lines and wrinkles. This will be assessed as a composite outcome.
Timepoint [1] 457566 0
Baseline, 4 weeks following treatment and 8 weeks following treatment
Secondary outcome [2] 457567 0
Mean change in transepidermal water loss
Timepoint [2] 457567 0
Baseline, 4 weeks following treatment and 8 weeks following treatment
Secondary outcome [3] 457568 0
Mean change in skin elasticity
Timepoint [3] 457568 0
Baseline, 4 weeks following treatment and 8 weeks following treatment
Secondary outcome [4] 457569 0
Effect of the product on self-reported skin-perception measures. This will be assessed as a composite secondary outcome.
Timepoint [4] 457569 0
Baseline, 4 weeks following treatment and 8 weeks following treatment

Eligibility
Key inclusion criteria
Female participants experiencing symptoms of skin dehydration with no skin conditions, aged 30-60 years, who consent to participate and willing/able to attend required study visits
Minimum age
30 Years
Maximum age
60 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Individuals using tanning beds within two months of screening, individuals undergoing dermatological, pharmacological or anti-aging/skin hydration treatments within two months of screening, Individuals diagnosed with any skin condition which may interfere with assessments, Individuals who are currently on systemic therapies and/or prescribed medical topical therapy, Individuals who have taken supplements containing any of the following in the last 14 days; collagen, ceramides, hyaluronic acid, Individuals who are pregnant and/or lactating, or who are planning to become pregnant during the study or four (4) weeks after the study, Individuals with known or suspected intolerance or hypersensitivity to the product ingredients (or closely related compounds) or any of their stated ingredients, Individuals who have participated in any other interventional study or have received any investigational drug within 30 days of the screening.

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)
Yes, allocation concealment occurs through number kit containers and through central randomisation list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 321114 0
Commercial sector/Industry
Name [1] 321114 0
Swisse Wellness Pty Ltd
Country [1] 321114 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Swisse Wellness Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 323818 0
None
Name [1] 323818 0
Address [1] 323818 0
Country [1] 323818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319644 0
Bellberry Human Research Ethics Committee I
Ethics committee address [1] 319644 0
Ethics committee country [1] 319644 0
Australia
Date submitted for ethics approval [1] 319644 0
28/05/2025
Approval date [1] 319644 0
28/10/2025
Ethics approval number [1] 319644 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 147970 0
Dr Joanne Grimsdale
Address 147970 0
Ozderm & Oztrials Clinical Research, Suite 1, 56-56A Thompson Street, Drummoyne, NSW 2047
Country 147970 0
Australia
Phone 147970 0
+61 02 9719 3852
Fax 147970 0
Email 147970 0
[email protected]
Contact person for public queries
Name 147971 0
Emanuela Elia
Address 147971 0
Ozderm & Oztrials Clinical Research, Suite 1, 56-56A Thompson Street, Drummoyne, NSW 2047
Country 147971 0
Australia
Phone 147971 0
+61 0297193852
Fax 147971 0
Email 147971 0
[email protected]
Contact person for scientific queries
Name 147972 0
Emanuela Elia
Address 147972 0
Ozderm & Oztrials Clinical Research, Suite 1, 56-56A Thompson Street, Drummoyne, NSW 2047
Country 147972 0
Australia
Phone 147972 0
+61 0297193852
Fax 147972 0
Email 147972 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.