Topical Palm Tocotrienols on Skin Biophysical Properties

November 27, 2023 updated by: Goh Choon Fu, Universiti Sains Malaysia

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
      • Pulau Pinang, Malaysia, 11800
        • School of Pharmaceutical Sciences, Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Other: Base cream
Apply on the face twice a day

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Collaborators

Malaysia Palm Oil Board
Avantsar Sdn. Bhd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2023

Primary Completion (Actual)

November 16, 2023

Study Completion (Actual)

November 16, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-T3-T1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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