Topical Palm Tocotrienols on Skin Biophysical Properties

Sponsor

Universiti Sains Malaysia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05787743

Collaborator

Malaysia Palm Oil Board (Other), Avantsar Sdn. Bhd. (Other)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wrinkle	Other: Facial cream with 2% palm tocotrienols extract Other: Base cream	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Facial cream with 2% palm tocotrienols extract Facial cream with 2% palm tocotrienols extract	Other: Facial cream with 2% palm tocotrienols extract Apply on the face twice a day
Placebo Comparator: Base cream (no active) Base cream (no active)	Other: Base cream Apply on the face twice a day

Arm

Intervention/Treatment

Active Comparator: Facial cream with 2% palm tocotrienols extract

Facial cream with 2% palm tocotrienols extract

Other: Facial cream with 2% palm tocotrienols extract

Apply on the face twice a day

Placebo Comparator: Base cream (no active)

Base cream (no active)

Other: Base cream

Apply on the face twice a day

Outcome Measures

Primary Outcome Measures

Percent change from baseline in wrinkle (SEw) [24 week]
Wrinkle

Secondary Outcome Measures

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%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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