Topical Palm Tocotrienols on Skin Biophysical Properties

Universiti Sains Malaysia

Status: Terminated

Conditions: Wrinkle

Treatments: Other: Facial cream with 2% palm tocotrienols extract; Other: Base cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05787743

MA-T3-T1

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

41 participants in 2 patient groups, including a placebo group

Facial cream with 2% palm tocotrienols extract

Active Comparator group

Description:

Facial cream with 2% palm tocotrienols extract

Treatment:

Other: Facial cream with 2% palm tocotrienols extract

Base cream (no active)

Placebo Comparator group

Description:

Base cream (no active)

Treatment:

Other: Base cream