Topical Palm Tocotrienols on Blemish-prone Skin

Not Applicable

Terminated

• Conditions: Acne
• Interventions: Other: Cosmetic product

• Registration Number: NCT05756881
• Lead Sponsor: Universiti Sains Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-10
• Study Start: 2023-02-15
• Study First Submitted QC: 2023-03-04
• Study First Posted: 2023-03-06
• Status Verified: 2023-11
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate	Cosmetic product	Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate
Serum (placebo)	Cosmetic product	Serum (placebo)

Primary Outcome Measures

Name	Time	Method
Proportion of participants with at least 50% reduction in numbers of acne lesion or at least 2 grade improvement according to CASS from baseline	18 Week	Acne lesion count

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Pharmaceutical Sciences, Universiti Sains Malaysia; 🇲🇾 Pulau Pinang, Malaysia