WrinkleNCT05787743
Topical Palm Tocotrienols on Skin Biophysical Properties
A study testing Facial cream with 2% palm tocotrienols extract and Base cream in people with Wrinkle, 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 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Facial cream with 2% palm tocotrienols extract and Base cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Jul 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female individuals, aged 25 - 45 years old, inclusive
- Fitzpatrick skin type II to IV
- In generally good health and skin condition as determined by the PI or designee, based on medical history reported by the subject.
- Willing to provide informed consent and comply with study procedures
Who cannot join
- Has a history of chronic drug or alcohol abuse
- Is current smoker
- History of severe allergic reactions to topical products or vitamin E
- Participant with severe and uncontrolled 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
- 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
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-blinded Placebo Controlled Study on the Effect of Topical Palm Tocotrienol on Skin Biophysical Properties
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 24-weeks of use.
- Conditions
- Wrinkle
- Being tested
- Facial cream with 2% palm tocotrienols extract, Base cream
- Keywords
- tocotrienol, wrinkle, skin, topical, biophysical properties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial cream with 2% palm tocotrienols extractOther
Apply on the face twice a day
Base creamOther
Apply on the face twice a day
| Study group | Role | What they receive |
|---|---|---|
| Facial cream with 2% palm tocotrienols extract | Active comparator | Facial cream with 2% palm tocotrienols extract Receives: Other: Facial cream with 2% palm tocotrienols extract |
| Base cream (no active) | Placebo comparator | Base cream (no active) Receives: Other: Base cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in wrinkle (SEw)
Wrinkle
Measured: 24 week
Secondary outcomes (3)
Percent change from baseline in roughness (SEr), scaliness(SEsc), smoothness (SEsm), TEWL, Young's modulus, viscoelasticity, retraction time, collagen content, skin thickness, pigmentation index, erythema index, skin colour, pH, sebum and hydration
Skin biophysical properties
Measured: 24 week
Percent change from baseline for Lemperle Wrinkle Assessment Scale
Wrinkle (scale 1 - 5; higher score for more wrinkles)
Measured: 24 week
Percent change from baseline in scores of survey (BeautyQoL)
Survey (score 0 - 100%)
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start17 Jul 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 (25)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies 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
- 41 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787743
- Sponsor's protocol ID
- MA-T3-T1
- Status last verified
- Nov 2023
- First submitted
- 17 Feb 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi B, Heo JH, Kwon HJ, Lee ES, Sohn S. Tocotrienols enhance melanosome degradation through endosome docking/fusion proteins in B16F10 melanoma cells. Food Funct. 2013 Oct;4(10):1481-8. doi: 10.1039/c3fo60289c.
PubMed 23995710Chu CC, Hasan ZABA, Tan CP, Nyam KL. In Vitro Antiaging Evaluation of Sunscreen Formulated from Nanostructured Lipid Carrier and Tocotrienol-Rich Fraction. J Pharm Sci. 2021 Dec;110(12):3929-3936. doi: 10.1016/j.xphs.2021.08.020. Epub 2021 Aug 21.
PubMed 34425132Draize, J.H., Woodard, G., Calvery, H.O., 1944. 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, 377-390.
Harun MS, Wong TW, Fong CW. Advancing skin delivery of alpha-tocopherol and gamma-tocotrienol for dermatitis treatment via nanotechnology and microwave technology. Int J Pharm. 2021 Jan 25;593:120099. doi: 10.1016/j.ijpharm.2020.120099. Epub 2020 Nov 28.
PubMed 33259902Ikeda 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 10955281Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
PubMed 11711957Makpol S, Abidin AZ, Sairin K, Mazlan M, Top GM, Ngah WZ. gamma-Tocotrienol prevents oxidative stress-induced telomere shortening in human fibroblasts derived from different aged individuals. Oxid Med Cell Longev. 2010 Jan-Feb;3(1):35-43. doi: 10.4161/oxim.3.1.9940.
PubMed 20716926Mei Yee, C., Ahmad, N., Azizul Hasan, Z.A., Abu Hasan, H., 2014. Tocotrienol-Based Facial Masks, MPOB Information Series. Malaysian Palm Oil Board, Kuala Lumpur, Malaysia.
Muggli R. Systemic evening primrose oil improves the biophysical skin parameters of healthy adults. Int J Cosmet Sci. 2005 Aug;27(4):243-9. doi: 10.1111/j.1467-2494.2005.00274.x.
PubMed 18492193Musalmah M, Nizrana MY, Fairuz AH, NoorAini AH, Azian AL, Gapor MT, Wan Ngah WZ. Comparative effects of palm vitamin E and alpha-tocopherol on healing and wound tissue antioxidant enzyme levels in diabetic rats. Lipids. 2005 Jun;40(6):575-80. doi: 10.1007/s11745-005-1418-9.
PubMed 16149736Patel 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 22298568Pedrelli VF, Lauriola MM, Pigatto PD. Clinical evaluation of photoprotective effect by a topical antioxidants combination (tocopherols and tocotrienols). J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1449-53. doi: 10.1111/j.1468-3083.2011.04219.x. Epub 2011 Sep 14.
PubMed 21917024Sen 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 17507086Shibata A, Nakagawa K, Kawakami Y, Tsuzuki T, Miyazawa T. Suppression of gamma-tocotrienol on UVB induced inflammation in HaCaT keratinocytes and HR-1 hairless mice via inflammatory mediators multiple signaling. J Agric Food Chem. 2010 Jun 9;58(11):7013-20. doi: 10.1021/jf100691g.
PubMed 20465215Suzuki 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 8399214
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blinded Placebo Controlled Study on the Effect of Topical Palm Tocotrienol on Skin Biophysical Properties
- ClinicalTrials.gov ID
- NCT05787743
- Acronym / sponsor ID
- MA-T3-T1
- Conditions
- Wrinkle
- Keywords
- tocotrienol, wrinkle, skin, topical, biophysical properties
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrawal
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Avantsar Sdn. Bhd.
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 28 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 24-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 |
|---|---|---|
| Facial cream with 2% palm tocotrienols extract | Active comparator | Other: Facial cream with 2% palm tocotrienols extractFacial cream with 2% palm tocotrienols extract |
| Base cream (no active) | Placebo comparator | Other: Base creamBase cream (no active) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female individuals, aged 25 - 45 years old, inclusive
- Fitzpatrick skin type II to IV
- In generally good health and skin condition as determined by the PI or designee, based on medical history reported by the subject.
- Willing to provide informed consent and comply with study procedures
Key exclusion criteria (8 listed)
- Has a history of chronic drug or alcohol abuse
- Is current smoker
- History of severe allergic reactions to topical products or vitamin E
- Participant with severe and uncontrolled 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 |
|---|---|---|
| Facial cream with 2% palm tocotrienols extractApply on the face twice a day | Other | Facial cream with 2% palm tocotrienols extract |
| Base creamApply on the face twice a day | Other | Base cream (no active) |
Primary outcome
Percent change from baseline in wrinkle (SEw)
Time frame: 24 week
Wrinkle
3 secondary outcomes
Percent change from baseline in roughness (SEr), scaliness(SEsc), smoothness (SEsm), TEWL, Young's modulus, viscoelasticity, retraction time, collagen content, skin thickness, pigmentation index, erythema index, skin colour, pH, sebum and hydration
Time frame: 24 week
Percent change from baseline for Lemperle Wrinkle Assessment Scale
Time frame: 24 week
Percent change from baseline in scores of survey (BeautyQoL)
Time frame: 24 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 1 Dec 2023.
- Background: PubMed 23995710Choi B, Heo JH, Kwon HJ, Lee ES, Sohn S. Tocotrienols enhance melanosome degradation through endosome docking/fusion proteins in B16F10 melanoma cells. Food Funct. 2013 Oct;4(10):1481-8. doi: 10.1039/c3fo60289c.
- Background: PubMed 34425132Chu CC, Hasan ZABA, Tan CP, Nyam KL. In Vitro Antiaging Evaluation of Sunscreen Formulated from Nanostructured Lipid Carrier and Tocotrienol-Rich Fraction. J Pharm Sci. 2021 Dec;110(12):3929-3936. doi: 10.1016/j.xphs.2021.08.020. Epub 2021 Aug 21.
- BackgroundDraize, J.H., Woodard, G., Calvery, H.O., 1944. 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, 377-390.
- Background: PubMed 33259902Harun MS, Wong TW, Fong CW. Advancing skin delivery of alpha-tocopherol and gamma-tocotrienol for dermatitis treatment via nanotechnology and microwave technology. Int J Pharm. 2021 Jan 25;593:120099. doi: 10.1016/j.ijpharm.2020.120099. Epub 2020 Nov 28.
- 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 11711957Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
- Background: PubMed 20716926Makpol S, Abidin AZ, Sairin K, Mazlan M, Top GM, Ngah WZ. gamma-Tocotrienol prevents oxidative stress-induced telomere shortening in human fibroblasts derived from different aged individuals. Oxid Med Cell Longev. 2010 Jan-Feb;3(1):35-43. doi: 10.4161/oxim.3.1.9940.
- BackgroundMei Yee, C., Ahmad, N., Azizul Hasan, Z.A., Abu Hasan, H., 2014. Tocotrienol-Based Facial Masks, MPOB Information Series. Malaysian Palm Oil Board, Kuala Lumpur, Malaysia.
- Background: PubMed 18492193Muggli R. Systemic evening primrose oil improves the biophysical skin parameters of healthy adults. Int J Cosmet Sci. 2005 Aug;27(4):243-9. doi: 10.1111/j.1467-2494.2005.00274.x.
- Background: PubMed 16149736Musalmah M, Nizrana MY, Fairuz AH, NoorAini AH, Azian AL, Gapor MT, Wan Ngah WZ. Comparative effects of palm vitamin E and alpha-tocopherol on healing and wound tissue antioxidant enzyme levels in diabetic rats. Lipids. 2005 Jun;40(6):575-80. doi: 10.1007/s11745-005-1418-9.
- 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 21917024Pedrelli VF, Lauriola MM, Pigatto PD. Clinical evaluation of photoprotective effect by a topical antioxidants combination (tocopherols and tocotrienols). J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1449-53. doi: 10.1111/j.1468-3083.2011.04219.x. Epub 2011 Sep 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial cream with 2% palm tocotrienols extract and Base cream in people with Wrinkle, 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 4 inclusion and 8 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 1 Dec 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?
Percent change from baseline in wrinkle (SEw) (time frame: 24 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 NCT05787743, which also lists 25 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 1 Dec 2023.