AcneNCT05756881
Topical Palm Tocotrienols on Blemish-prone Skin
A study testing Cosmetic product in people with Acne, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Cosmetic product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Feb 2023to 16 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
School of Pharmaceutical Sciences, Universiti Sains Malaysia
Pulau Pinang, 11800
About this study
Official title: A Randomised Double-blind Placebo-controlled Study on the Effects of Topical Palm Tocotrienols on Blemish-prone Skin
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.
- Conditions
- Acne
- Being tested
- Cosmetic product
- Keywords
- tocotrienol, acne, topical, skin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic productOther
Apply on the face twice a day
| Study group | Role | What they receive |
|---|---|---|
| Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate | Active comparator | Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate Receives: Other: Cosmetic product |
| Serum (placebo) | Placebo comparator | Serum (placebo) Receives: Other: Cosmetic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 Week
Secondary outcomes (5)
The percent change from baseline in global face total lesion count.
Acne lesion count
Measured: 18 Week
Acne lesion counts for the total global face and total lesion counts
Acne lesion count
Measured: 18 Week
CASS assessment
Comprehensive Acne Severity Scale (CASS)
Measured: 18 Week
Survey (CADI)
The Cardiff Acne Disability Index 2021
Measured: 18 Week
The percent change from baseline in sebum, skin pH, hydration and erythema index
Skin probe
Measured: 18 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start15 Feb 2023
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Why it stopped: Sponsor withdrawal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Avantsar Sdn. Bhd.
- Responsible party
- Principal investigator, Goh Choon Fu, Universiti Sains Malaysia
- Investigators
- Choon Fu Goh, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756881
- Sponsor's protocol ID
- MA-T3-T3
- Status last verified
- Nov 2023
- First submitted
- 10 Feb 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sen CK, Khanna S, Roy S. Tocotrienols in health and disease: the other half of the natural vitamin E family. Mol Aspects Med. 2007 Oct-Dec;28(5-6):692-728. doi: 10.1016/j.mam.2007.03.001. Epub 2007 Mar 27.
PubMed 17507086Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.
PubMed 22298568Ikeda S, Niwa T, Yamashita K. Selective uptake of dietary tocotrienols into rat skin. J Nutr Sci Vitaminol (Tokyo). 2000 Jun;46(3):141-3. doi: 10.3177/jnsv.46.141.
PubMed 10955281Traber MG, Podda M, Weber C, Thiele J, Rallis M, Packer L. Diet-derived and topically applied tocotrienols accumulate in skin and protect the tissue against ultraviolet light-induced oxidative stress. Asia Pac J Clin Nutr. 1997 Mar;6(1):63-7.
PubMed 24394657Suzuki YJ, Tsuchiya M, Wassall SR, Choo YM, Govil G, Kagan VE, Packer L. Structural and dynamic membrane properties of alpha-tocopherol and alpha-tocotrienol: implication to the molecular mechanism of their antioxidant potency. Biochemistry. 1993 Oct 12;32(40):10692-9. doi: 10.1021/bi00091a020.
PubMed 8399214Thiele JJ, Traber MG, Podda M, Tsang K, Cross CE, Packer L. Ozone depletes tocopherols and tocotrienols topically applied to murine skin. FEBS Lett. 1997 Jan 20;401(2-3):167-70. doi: 10.1016/s0014-5793(96)01463-9.
PubMed 9013880Thiele JJ, Traber MG, Tsang K, Cross CE, Packer L. In vivo exposure to ozone depletes vitamins C and E and induces lipid peroxidation in epidermal layers of murine skin. Free Radic Biol Med. 1997;23(3):385-91. doi: 10.1016/s0891-5849(96)00617-x.
PubMed 9214574N.Z. Yusuf, Z.A. Azizul Hasan, R. Ismail, TOCOGELS As Anti-Inflammatory Agents, in: MPOB Information Series, Malaysian Palm Oil Board, Kuala Lumpur, Malaysia, 2011.
Zouboulis CC. Acne and sebaceous gland function. Clin Dermatol. 2004 Sep-Oct;22(5):360-6. doi: 10.1016/j.clindermatol.2004.03.004.
PubMed 15556719Suppiah TSS, Sundram TKM, Tan ESS, Lee CK, Bustami NA, Tan CK. Acne vulgaris and its association with dietary intake: a Malaysian perspective. Asia Pac J Clin Nutr. 2018;27(5):1141-1145. doi: 10.6133/apjcn.072018.01.
PubMed 30272862Hanisah A, Omar K, Shah SA. Prevalence of acne and its impact on the quality of life in school-aged adolescents in Malaysia. J Prim Health Care. 2009 Mar;1(1):20-5.
PubMed 20690482F.B.-B. Yap, The impact of acne vulgaris on the quality of life in Sarawak, Malaysia, Journal of the Saudi Society of Dermatology & Dermatologic Surgery, 16 (2012) 57-60.
Lim TH, Badaruddin NSF, Foo SY, Bujang MA, Muniandy P. Prevalence and psychosocial impact of acne vulgaris among high school and university students in Sarawak, Malaysia. Med J Malaysia. 2022 Jul;77(4):446-453.
PubMed 35902934Loh KC, Chan LC, Phang LF. Perceptions and psychosocial judgement of patients with acne vulgaris. Med J Malaysia. 2020 Jan;75(1):18-23.
PubMed 32008014J.H. Draize, G. Woodard, H.O. Calvery, Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes, Journal of Pharmacology and Experimental Therapeutics, 82 (1944) 377-390.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Placebo-controlled Study on the Effects of Topical Palm Tocotrienols on Blemish-prone Skin
- ClinicalTrials.gov ID
- NCT05756881
- Acronym / sponsor ID
- MA-T3-T3
- Conditions
- Acne
- Keywords
- tocotrienol, acne, topical, skin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrawal
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Avantsar Sdn. Bhd.
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate | Active comparator | Other: Cosmetic productSerum containing 1.5 % w/w of palm-oil derived vitamin E concentrate |
| Serum (placebo) | Placebo comparator | Other: Cosmetic productSerum (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic productApply on the face twice a day | Other | Serum (placebo), Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate |
Primary outcome
Proportion of participants with at least 50% reduction in numbers of acne lesion or at least 2 grade improvement according to CASS from baseline
Time frame: 18 Week
Acne lesion count
5 secondary outcomes
The percent change from baseline in global face total lesion count.
Time frame: 18 Week
Acne lesion counts for the total global face and total lesion counts
Time frame: 18 Week
CASS assessment
Time frame: 18 Week
Survey (CADI)
Time frame: 18 Week
The percent change from baseline in sebum, skin pH, hydration and erythema index
Time frame: 18 Week
Results and safety
The study was stopped early (reason given: Sponsor withdrawal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 17507086Sen CK, Khanna S, Roy S. Tocotrienols in health and disease: the other half of the natural vitamin E family. Mol Aspects Med. 2007 Oct-Dec;28(5-6):692-728. doi: 10.1016/j.mam.2007.03.001. Epub 2007 Mar 27.
- Background: PubMed 22298568Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.
- Background: PubMed 10955281Ikeda S, Niwa T, Yamashita K. Selective uptake of dietary tocotrienols into rat skin. J Nutr Sci Vitaminol (Tokyo). 2000 Jun;46(3):141-3. doi: 10.3177/jnsv.46.141.
- Background: PubMed 24394657Traber MG, Podda M, Weber C, Thiele J, Rallis M, Packer L. Diet-derived and topically applied tocotrienols accumulate in skin and protect the tissue against ultraviolet light-induced oxidative stress. Asia Pac J Clin Nutr. 1997 Mar;6(1):63-7.
- Background: PubMed 8399214Suzuki YJ, Tsuchiya M, Wassall SR, Choo YM, Govil G, Kagan VE, Packer L. Structural and dynamic membrane properties of alpha-tocopherol and alpha-tocotrienol: implication to the molecular mechanism of their antioxidant potency. Biochemistry. 1993 Oct 12;32(40):10692-9. doi: 10.1021/bi00091a020.
- Background: PubMed 9013880Thiele JJ, Traber MG, Podda M, Tsang K, Cross CE, Packer L. Ozone depletes tocopherols and tocotrienols topically applied to murine skin. FEBS Lett. 1997 Jan 20;401(2-3):167-70. doi: 10.1016/s0014-5793(96)01463-9.
- Background: PubMed 9214574Thiele JJ, Traber MG, Tsang K, Cross CE, Packer L. In vivo exposure to ozone depletes vitamins C and E and induces lipid peroxidation in epidermal layers of murine skin. Free Radic Biol Med. 1997;23(3):385-91. doi: 10.1016/s0891-5849(96)00617-x.
- BackgroundN.Z. Yusuf, Z.A. Azizul Hasan, R. Ismail, TOCOGELS As Anti-Inflammatory Agents, in: MPOB Information Series, Malaysian Palm Oil Board, Kuala Lumpur, Malaysia, 2011.
- Background: PubMed 15556719Zouboulis CC. Acne and sebaceous gland function. Clin Dermatol. 2004 Sep-Oct;22(5):360-6. doi: 10.1016/j.clindermatol.2004.03.004.
- Background: PubMed 30272862Suppiah TSS, Sundram TKM, Tan ESS, Lee CK, Bustami NA, Tan CK. Acne vulgaris and its association with dietary intake: a Malaysian perspective. Asia Pac J Clin Nutr. 2018;27(5):1141-1145. doi: 10.6133/apjcn.072018.01.
- Background: PubMed 20690482Hanisah A, Omar K, Shah SA. Prevalence of acne and its impact on the quality of life in school-aged adolescents in Malaysia. J Prim Health Care. 2009 Mar;1(1):20-5.
- BackgroundF.B.-B. Yap, The impact of acne vulgaris on the quality of life in Sarawak, Malaysia, Journal of the Saudi Society of Dermatology & Dermatologic Surgery, 16 (2012) 57-60.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choon Fu Goh, PhD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic product in people with Acne, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor withdrawal). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 18 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756881, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.