Clinical trial NCT05787743: Topical Palm Tocotrienols on Skin Biophysical Properties
Official title: A Randomised Double-blinded Placebo Controlled Study on the Effect of Topical Palm Tocotrienol on Skin Biophysical Properties
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wrinkle
Keywords: tocotrienol
wrinkle
skin
topical
biophysical properties
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Malaysia Palm Oil Board
name: Avantsar Sdn. Bhd.
First posted: 2023-03-28
Enrollment: 41
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change from baseline in wrinkle (SEw)
timeFrame: 24 week
Secondary outcomes:
measure: 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
timeFrame: 24 week
measure: Percent change from baseline for Lemperle Wrinkle Assessment Scale
timeFrame: 24 week
measure: Percent change from baseline in scores of survey (BeautyQoL)
timeFrame: 24 week
Other outcomes:
Locations:
city: Pulau Pinang
country: Malaysia
facility: School of Pharmaceutical Sciences, Universiti Sains Malaysia
Study officials:
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