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Sponsor withdrawal
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| Name | Class |
|---|---|
| Malaysia Palm Oil Board | OTHER_GOV |
| Avantsar Sdn. Bhd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Serum (placebo) | Placebo Comparator | Serum (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic product | Other | Apply on the face twice a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Choon Fu Goh, PhD | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Pharmaceutical Sciences, Universiti Sains Malaysia | Pulau Pinang | 11800 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17507086 | Background | 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. | |
| 22298568 | Background | 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. |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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| 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 |
| 10955281 | Background | 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. |
| 24394657 | Background | 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. |
| 8399214 | Background | 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. |
| 9013880 | Background | 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. |
| 9214574 | Background | 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. |
| Background | 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. |
| 15556719 | Background | Zouboulis CC. Acne and sebaceous gland function. Clin Dermatol. 2004 Sep-Oct;22(5):360-6. doi: 10.1016/j.clindermatol.2004.03.004. |
| 30272862 | Background | 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. |
| 20690482 | Background | 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. |
| Background | 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. |
| 35902934 | Background | 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. |
| 32008014 | Background | Loh KC, Chan LC, Phang LF. Perceptions and psychosocial judgement of patients with acne vulgaris. Med J Malaysia. 2020 Jan;75(1):18-23. |
| Background | 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. |
| Background | 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. |