Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2023-02-15
2023-11-16
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate
Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate
Cosmetic product
Apply on the face twice a day
Serum (placebo)
Serum (placebo)
Cosmetic product
Apply on the face twice a day
Interventions
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Cosmetic product
Apply on the face twice a day
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Malaysia Palm Oil Board
OTHER_GOV
Avantsar Sdn. Bhd.
UNKNOWN
Universiti Sains Malaysia
OTHER
Responsible Party
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Goh Choon Fu
Principal Investigator
Principal Investigators
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Choon Fu Goh, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Sains Malaysia
Locations
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School of Pharmaceutical Sciences, Universiti Sains Malaysia
Pulau Pinang, , Malaysia
Countries
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References
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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.
Patel 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.
Ikeda 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.
Traber 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.
Suzuki 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.
Thiele 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.
Thiele 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.
N.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.
Suppiah 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.
Hanisah 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.
F.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.
Loh KC, Chan LC, Phang LF. Perceptions and psychosocial judgement of patients with acne vulgaris. Med J Malaysia. 2020 Jan;75(1):18-23.
J.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.
A.F.M. Hani, A.S. Malik, F.B. Yap, R. Ramli, Segmentation of Acne Vulgaris Lesions, in: Digital Image Computing: Techniques and Applications, Noosa, Queensland Australia, 2008, pp. 335-339.
Other Identifiers
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MA-T3-T3
Identifier Type: -
Identifier Source: org_study_id