Clinical trial NCT05756881: Topical Palm Tocotrienols on Blemish-prone Skin
Official title: A Randomised Double-blind Placebo-controlled Study on the Effects of Topical Palm Tocotrienols on Blemish-prone Skin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acne
Keywords: tocotrienol
acne
topical
skin
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Malaysia Palm Oil Board
name: Avantsar Sdn. Bhd.
First posted: 2023-03-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_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 12-weeks of use.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with at least 50% reduction in numbers of acne lesion or at least 2 grade improvement according to CASS from baseline
timeFrame: 18 Week
Secondary outcomes:
measure: The percent change from baseline in global face total lesion count.
timeFrame: 18 Week
measure: Acne lesion counts for the total global face and total lesion counts
timeFrame: 18 Week
measure: CASS assessment
timeFrame: 18 Week
measure: Survey (CADI)
timeFrame: 18 Week
measure: The percent change from baseline in sebum, skin pH, hydration and erythema index
timeFrame: 18 Week
Other outcomes:
Locations:
city: Pulau Pinang
country: Malaysia
facility: School of Pharmaceutical Sciences, Universiti Sains Malaysia
Study officials:
affiliation: Universiti Sains Malaysia
name: Choon Fu Goh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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