Topical Palm Tocotrienols on Skin Biophysical Properties

NCT05787743 | Terminated

• 1 other identifier: MA-T3-T1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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 24-weeks of use.

Conditions

Wrinkle

Keywords

tocotrienol; wrinkle; skin; topical; biophysical properties

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in wrinkle (SEw)

  Wrinkle

  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

  24 week

• Percent change from baseline for Lemperle Wrinkle Assessment Scale

  24 week

• Percent change from baseline in scores of survey (BeautyQoL)

  24 week

Study Arms (2)

Facial cream with 2% palm tocotrienols extract

ACTIVE COMPARATOR

Facial cream with 2% palm tocotrienols extract

Other: Facial cream with 2% palm tocotrienols extract

Base cream (no active)

PLACEBO COMPARATOR

Base cream (no active)

Other: Base cream

Interventions

Facial cream with 2% palm tocotrienols extract OTHER

Apply on the face twice a day

Facial cream with 2% palm tocotrienols extract

Base cream OTHER

Apply on the face twice a day

Base cream (no active)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Malaysia Palm Oil Board: collaborator
• Avantsar Sdn. Bhd.: collaborator

Study Sites (1)

School of Pharmaceutical Sciences, Universiti Sains Malaysia

Pulau Pinang, 11800, Malaysia

Location

Related Publications (25)

• 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.

  PMID: 23995710 BACKGROUND

• Chu 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.

  PMID: 34425132 BACKGROUND

• Draize, 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

• 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.

  PMID: 33259902 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.

  PMID: 10955281 BACKGROUND

• Lemperle 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.

  PMID: 11711957 BACKGROUND

• Makpol 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.

  PMID: 20716926 BACKGROUND

• Mei 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

• 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.

  PMID: 18492193 BACKGROUND

• Musalmah 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.

  PMID: 16149736 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.

  PMID: 22298568 BACKGROUND

• Pedrelli 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.

  PMID: 21917024 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.

  PMID: 17507086 BACKGROUND

• Shibata 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.

  PMID: 20465215 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.

  PMID: 8399214 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.

  PMID: 9013880 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.

  PMID: 9214574 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.

  PMID: 24394657 BACKGROUND

• Tsuduki T, Kuriyama K, Nakagawa K, Miyazawa T. Tocotrienol (unsaturated vitamin E) suppresses degranulation of mast cells and reduces allergic dermatitis in mice. J Oleo Sci. 2013;62(10):825-34. doi: 10.5650/jos.62.825.

  PMID: 24088520 BACKGROUND

• Yamada Y, Obayashi M, Ishikawa T, Kiso Y, Ono Y, Yamashita K. Dietary tocotrienol reduces UVB-induced skin damage and sesamin enhances tocotrienol effects in hairless mice. J Nutr Sci Vitaminol (Tokyo). 2008 Apr;54(2):117-23. doi: 10.3177/jnsv.54.117.

  PMID: 18490840 BACKGROUND

• Yamashita, E., 2006. Cosmetic benefit of dietary supplements including astaxanthin and tocotrienol on human skin.

  BACKGROUND

• Yap WN. Tocotrienol-rich fraction attenuates UV-induced inflammaging: A bench to bedside study. J Cosmet Dermatol. 2018 Jun;17(3):555-565. doi: 10.1111/jocd.12421. Epub 2017 Sep 26.

  PMID: 28952200 BACKGROUND

• Yap WN, Zaiden N, Xu CH, Chen A, Ong S, Teo V, Yap YL. Gamma- and delta-tocotrienols inhibit skin melanin synthesis by suppressing constitutive and UV-induced tyrosinase activation. Pigment Cell Melanoma Res. 2010 Oct;23(5):688-92. doi: 10.1111/j.1755-148X.2010.00740.x. Epub 2010 Jul 27. No abstract available.

  PMID: 20609176 BACKGROUND

• Yusuf, N.Z., Azizul Hasan, Z.A., Ismail, R., 2011. TOCOGELS As Anti-Inflammatory Agents, MPOB Information Series. Malaysian Palm Oil Board, Kuala Lumpur, Malaysia.

  BACKGROUND

• Zainal Z, Khaza'ai H, Kutty Radhakrishnan A, Chang SK. Therapeutic potential of palm oil vitamin E-derived tocotrienols in inflammation and chronic diseases: Evidence from preclinical and clinical studies. Food Res Int. 2022 Jun;156:111175. doi: 10.1016/j.foodres.2022.111175. Epub 2022 Mar 21.

  PMID: 35651097 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 28, 2023
• Study Start: July 17, 2023
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)