CompletedPhase 3ACTRN12621000709842

Effect of topical and oral Resveratrol on skin health, condition and visible signs of ageing, in healthy ageing females.


Sponsor

RDC Clinical Pty Ltd

Enrollment

140 participants

Start Date

Sep 6, 2021

Study Type

Interventional

Conditions

Summary

Effect of topical and oral Resveratrol on skin health, condition and visible signs of ageing, in healthy ageing females. This study aims to assess the effectiveness of Resveratrol for skin health parameters and visible signs of ageing compared to a placebo in otherwise healthy females aged over 40 years old. This study hypothesises that oral supplementation and topical application of Resveratrol will improve skin health parameters and ageing, including fine lines, wrinkles, uneven pigmentation, skin elasticity, hydration, visible pores and oxidative stress markers compared to the placebo products.


Eligibility

Sex: FemalesMin Age: 40 Yearss

Inclusion Criteria5

  • 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

Exclusion Criteria8

  • 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

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Interventions

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 visi

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.


Locations(1)

QLD, Australia

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ACTRN12621000709842