None listed
Conditions
Brief summary
This study uses a double-blind, placebo-controlled, randomized, parallel group study design. This study involves the testing for eight weeks of a TGA-listed off-shelf supplement (Swisse Nutra Cellular Skin Hydration product), The research study aims to compare the effect of the product against a placebo on objective measures of skin hydration, wrinkle reduction, water loss and skin elasticity, as well as change of the measures from first visit. It also aims to compare the end user experience of the product against a placebo in an eight-week real-life product testing.
Interventions
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) part
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.
Sponsors
Swisse Wellness Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Healthy volunteers
No
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
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.
Outcome results
None listed