Topical Palm Tocotrienols on Blemish-prone Skin

Universiti Sains Malaysia

Status: Terminated

Conditions: Acne

Treatments: Other: Cosmetic product

Study type: Interventional

Funder types: Other

Identifiers

NCT05756881

MA-T3-T3

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 12-weeks of use.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy individuals, aged 18 years and above
2. Fitzpatrick skin type II to IV
3. Blemish-prone skin with acne of severity grade 2 or 3 based on Comprehensive Acne Severity Scale (CASS)

Exclusion criteria

1. Has a history of chronic drug or alcohol abuse
2. Is a current smoker
3. History of severe allergic reactions to topical products or vitamin E
4. Participant with severe and uncontrollable 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 (such as polycystic ovary syndrome and contact dermatitis)
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
9. Has severe acne or acne conglobata
10. Use of systemic treatment for acne such as isotretinoin, contraceptive pills, or spironolactone within 4 weeks of screening visit
11. Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, salicylic acid, alpha hydroxy acids (AHAs), vitamins A (retinol) or C (ascorbic acid) or their analogs or derivatives and other anti-inflammatory drugs within 2 weeks of screening visit
12. Use of scrub, alpha-hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start
13. Participant with active bacterial/fungal/viral skin infections or susceptibility to such infections within 2 weeks of Screening visit
14. Use oral antibiotics

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate

Active Comparator group

Description:

Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate

Treatment:

Other: Cosmetic product

Serum (placebo)

Placebo Comparator group

Description:

Serum (placebo)

Treatment:

Other: Cosmetic product