Topical Palm Tocotrienols on Skin Biophysical Properties

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Double-blinded Placebo Controlled Study on the Effect of Topical Palm Tocotrienol on Skin Biophysical Properties

Conditions
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Wrinkle

Intervention / Treatment
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* Other: Facial cream with 2% palm tocotrienols extract
* Other: Base cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female individuals, aged 25 - 45 years old, inclusive Fitzpatrick skin type II to IV In generally good health and skin condition as determined by the PI or designee, based on medical history reported by the subject. Willing to provide informed consent and comply with study procedures Exclusion Criteria: Has a history of chronic drug or alcohol abuse Is current smoker History of severe allergic reactions to topical products or vitamin E Participant with severe and uncontrolled comorbidities (including but not limited to e.g. diabetes, hypertension, kidney failure) Pregnant, breastfeeding, or planning pregnancy 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 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 Participation in another study within 4 weeks of screening visit

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Facial cream with 2% palm tocotrienols extract<br>Facial cream with 2% palm tocotrienols extract | Other: Facial cream with 2% palm tocotrienols extract<br>* Apply on the face twice a day<br>|
| Placebo Comparator: Base cream (no active)<br>Base cream (no active) | Other: Base cream<br>* Apply on the face twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in wrinkle (SEw) | Wrinkle | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Skin biophysical properties | 24 week | 
| Percent change from baseline for Lemperle Wrinkle Assessment Scale | Wrinkle (scale 1 - 5; higher score for more wrinkles) | 24 week | 
| Percent change from baseline in scores of survey (BeautyQoL) | Survey (score 0 - 100%) | 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tocotrienol, wrinkle, skin, topical, biophysical properties