Wrinkle
Conditions
Keywords
tocotrienol, wrinkle, skin, topical, biophysical properties
Brief summary
A single-center, double-blind, randomised, placebo-controlled parallel-group study. Selected subjects will be randomised into active and control groups in a ratio of 1:1. Investigational products assigned will be applied on the facial skin as part of daily skin care routine. The effects will be observed during the 24-weeks of use.
Interventions
OTHERFacial cream with 2% palm tocotrienols extract
Apply on the face twice a day
OTHERBase cream
Apply on the face twice a day
Sponsors
Malaysia Palm Oil Board
Avantsar Sdn. Bhd.
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy female individuals, aged 25 - 45 years old, inclusive 2. Fitzpatrick skin type II to IV 3. In generally good health and skin condition as determined by the PI or designee, based on medical history reported by the subject. 4. Willing to provide informed consent and comply with study procedures
Exclusion criteria
1. Has a history of chronic drug or alcohol abuse 2. Is current smoker 3. History of severe allergic reactions to topical products or vitamin E 4. Participant with severe and uncontrolled comorbidities (including but not limited to e.g. diabetes, hypertension, kidney failure) 5. Pregnant, breastfeeding, or planning pregnancy 6. Participant with known skin conditions (including but not limited to e.g. sensitive skin, eczema and diseased skin e.g. contact dermatitis), uncontrolled medical conditions, or any other condition that could interfere with the study evaluations or increase risk to the participant 7. Participant with compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase risk 8. Participation in another study within 4 weeks of screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in wrinkle (SEw) | 24 week | Wrinkle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in roughness (SEr), scaliness(SEsc), smoothness (SEsm), TEWL, Young's modulus, viscoelasticity, retraction time, collagen content, skin thickness, pigmentation index, erythema index, skin colour, pH, sebum and hydration | 24 week | Skin biophysical properties |
| Percent change from baseline for Lemperle Wrinkle Assessment Scale | 24 week | Wrinkle (scale 1 - 5; higher score for more wrinkles) |
| Percent change from baseline in scores of survey (BeautyQoL) | 24 week | Survey (score 0 - 100%) |
Countries
Malaysia
Outcome results
None listed