Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000709842
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
8/06/2021
Date last updated
16/03/2023
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of topical and oral Resveratrol on skin health, condition and visible signs of ageing, in healthy ageing females.
Scientific title
Effect of topical and oral Resveratrol on skin health, condition and visible signs of ageing, in healthy ageing females.
Secondary ID [1] 304035 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin health 321665 0
Skin condition - pores, sebum, wrinkle, pigment condition, moisture, elasticity, skin tone
and skin temperature 321666 0
Visible signs of skin ageing 321667 0
Condition category
Condition code
Skin 319414 319414 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, randomised, placebo-controlled clinical study with an 8-week participation and 4 groups, assessing the effect of topical and oral Resveratrol on skin health, condition and visible signs of ageing, in healthy ageing females.

Once enrolled in the trial, participants will be randomly allocated to one of the four treatment groups on a 1:4 chance basis. Baseline skin assessment and a fasting blood test (fasted for at least 10 hours excluding water) will be completed at enrolment. Skin assessment includes the characterization of fine lines/wrinkles, pore size, pigmentation area, sebum, moisture, elasticity and skin temperature. Prior to the skin assessment and photograph being taken, participants will remove all make-up and lipstick using provided make-up removal wipes, hair will be cleared away from the face. The fasting blood sample will measure oxidation markers, Resveratrol concentration and metabolites.

Once the participant has completed the baseline measurements, they will be instructed to take/apply the allocated product according to the dose prescribed. Oral treatment (75 mg of Resveratrol per capsule. Total of 150mg of Resveratrol per day) will be taken twice daily in a single capsule with water (morning and evening). Topical treatment (1 g of cream containing 1.5% of Resveratrol) will be applied as 1g of cream topically morning and evening.
During the 8-week study period, participants will be asked to attend the study site at midpoint (week 4) and the end of the study (week 8) to repeat baseline measurements. At the end of the study (week 8), participants will be asked to complete an exit interview (completed by trained trial coordinators) and questionnaire. Participants will be required to attend the study site in a fasted state during all visits. At the end of the 8 weeks, participation in the study will be considered complete.

Participants will be monitored for compliance with the protocol by a combination of telephone and email communications in addition to during each scheduled visit.

Intervention code [1] 320356 0
Treatment: Other
Intervention code [2] 320667 0
Treatment: Drugs
Comparator / control treatment
Placebo Oral - The placebo will consist of microcrystalline cellulose encapsulated in opaque capsules to appear identical to the Resveratrol oral product. The placebo will be administered as per the active oral product (1 capsule in the morning and 1 capsule in the evening with water).

Placebo Topical - The cream is water based (oil in water emulsion) including the same ingredients as the active topical treatment with the exclusion of resveratrol. It will be applied as 1g of cream topically morning and evening as per the active topical product.
Control group
Placebo

Outcomes
Primary outcome [1] 327272 0
Change in wrinkles (fine and deep lines) as composite outcome -Measured using the A-One Smart Pro skin analysis system
Timepoint [1] 327272 0
Baseline, Week 4 and Week 8 (primary endpoint) post- commencement of intervention
Secondary outcome [1] 394418 0
Other Skin characteristics measured as a composite outcome (including pore, sebum, elasticity, tone and pigment condition. The attached probe measures skin temperature and moisture) – as measured by A-One Smart Pro skin analysis system
Timepoint [1] 394418 0
Baseline, week 4 and Week 8 post- commencement of intervention
Secondary outcome [2] 394419 0
Change in Subject self-assessment questionnaire (Designed for this study and consists of 17 questions related to overall satisfaction with the product and specific facial and skin properties)
Timepoint [2] 394419 0
Week 4 and Week 8 post- commencement of intervention
Secondary outcome [3] 394420 0
Biochemical Measurements (Oxidative stress markers, resveratrol concentration (free), metabolites (conjugated sulphate and glucuronidase)) as measured in plasma in composite outcome
Timepoint [3] 394420 0
Baseline, Week 4 and Week 8 post- commencement of intervention
Secondary outcome [4] 394421 0
Change in photography as assessed by visual assessment (pigment and skin condition)
Timepoint [4] 394421 0
Baseline, Week 4 and Week 8 post- commencement of intervention

Eligibility
Key inclusion criteria
• Females aged 40 years and above
• Otherwise healthy
• Agree not to change standard skincare routine
• Able to provide informed consent
• Agree not to undertake another clinical trial while enrolled in this trial
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, gastrointestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled
• Currently taking resveratrol or using resveratrol cream
• Cosmetic surgery and procedures, including Botox and other injectables, microdermabrasion, laser treatments
• Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
• Chronic past and/or current alcohol use (Greater than 14 alcoholic drinks week)
• Known pregnant or lactating woman
• Allergies or hypersensitivity to resveratrol
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2021
Actual
6/09/2021
Date of last participant enrolment
Anticipated
Actual
26/09/2022
Date of last data collection
Anticipated
Actual
29/11/2022
Sample size
Target
140
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308417 0
Commercial sector/Industry
Name [1] 308417 0
Evolva AG
Country [1] 308417 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
RDC Clinical Pty Ltd
Address
3/76 Doggett Street,
Newstead, QLD 4006
Country
Australia
Secondary sponsor category [1] 309252 0
Commercial sector/Industry
Name [1] 309252 0
Evolva AG
Address [1] 309252 0
Duggingerstrasse 23
4153 Reinach, Switzerland
Country [1] 309252 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308379 0
Bellberry Limited
Ethics committee address [1] 308379 0
Ethics committee country [1] 308379 0
Australia
Date submitted for ethics approval [1] 308379 0
08/04/2021
Approval date [1] 308379 0
11/06/2021
Ethics approval number [1] 308379 0

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

Contacts
Principal investigator
Name 110506 0
Dr Amanda Rao
Address 110506 0
RDC Clinical Pty Ltd
3/76 Doggett street
Newstead, QLD 4006
Country 110506 0
Australia
Phone 110506 0
+61 414 488 559
Fax 110506 0
Email 110506 0
[email protected]
Contact person for public queries
Name 110507 0
Amanda Rao
Address 110507 0
RDC Clinical Pty Ltd
3/76 Doggett street
Newstead, QLD 4006
Country 110507 0
Australia
Phone 110507 0
+61 414 488 559
Fax 110507 0
Email 110507 0
[email protected]
Contact person for scientific queries
Name 110508 0
Amanda Rao
Address 110508 0
RDC Clinical Pty Ltd
3/76 Doggett street
Newstead, QLD 4006
Country 110508 0
Australia
Phone 110508 0
+61 414 488 559
Fax 110508 0
Email 110508 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
No IPD will be shared


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.