Topical Palm Tocotrienols on Skin Biophysical Properties

Not Applicable

Terminated

• Conditions: Wrinkle
• Interventions: Other: Facial cream with 2% palm tocotrienols extract; Other: Base cream

• Registration Number: NCT05787743
• Lead Sponsor: Universiti Sains Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-28
• Study Start: 2023-07-17
• Status Verified: 2023-11
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facial cream with 2% palm tocotrienols extract	Facial cream with 2% palm tocotrienols extract	Facial cream with 2% palm tocotrienols extract
Base cream (no active)	Base cream	Base cream (no active)

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in wrinkle (SEw)	24 week	Wrinkle

Secondary Outcome Measures

Name	Time	Method
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%)
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

Trial Locations

Locations (1)

School of Pharmaceutical Sciences, Universiti Sains Malaysia; 🇲🇾 Pulau Pinang, Malaysia