Topical Palm Tocotrienols on Blemish-prone Skin

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Double-blind Placebo-controlled Study on the Effects of Topical Palm Tocotrienols on Blemish-prone Skin

Conditions
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Acne

Intervention / Treatment
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* Other: Cosmetic product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy individuals, aged 18 years and above Fitzpatrick skin type II to IV Blemish-prone skin with acne of severity grade 2 or 3 based on Comprehensive Acne Severity Scale (CASS) Exclusion Criteria: Has a history of chronic drug or alcohol abuse Is a current smoker History of severe allergic reactions to topical products or vitamin E Participant with severe and uncontrollable comorbidities (including but not limited to e.g. diabetes, hypertension, kidney failure) Pregnant, breastfeeding, or planning pregnancy 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) 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 Participation in another study within 4 weeks of screening visit Has severe acne or acne conglobata Use of systemic treatment for acne such as isotretinoin, contraceptive pills, or spironolactone within 4 weeks of screening visit 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 Use of scrub, alpha-hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start Participant with active bacterial/fungal/viral skin infections or susceptibility to such infections within 2 weeks of Screening visit Use oral antibiotics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate<br>Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate | Other: Cosmetic product<br>* Apply on the face twice a day<br>|
| Placebo Comparator: Serum (placebo)<br>Serum (placebo) | Other: Cosmetic product<br>* Apply on the face twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with at least 50% reduction in numbers of acne lesion or at least 2 grade improvement according to CASS from baseline | Acne lesion count | 18 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline in global face total lesion count. | Acne lesion count | 18 Week | 
| Acne lesion counts for the total global face and total lesion counts | Acne lesion count | 18 Week | 
| CASS assessment | Comprehensive Acne Severity Scale (CASS) | 18 Week | 
| Survey (CADI) | The Cardiff Acne Disability Index 2021 | 18 Week | 
| The percent change from baseline in sebum, skin pH, hydration and erythema index | Skin probe | 18 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tocotrienol, acne, topical, skin