NCT05756881

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 12-weeks of use.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

February 10, 2023

Last Update Submit

November 27, 2023

Conditions

Acne

Keywords

tocotrienolacnetopicalskin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • The percent change from baseline in global face total lesion count.

    18 Week

  • Acne lesion counts for the total global face and total lesion counts

    18 Week

  • CASS assessment

    18 Week

  • Survey (CADI)

    18 Week

  • The percent change from baseline in sebum, skin pH, hydration and erythema index

    18 Week

Study Arms (2)

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

Other: Cosmetic product

Serum (placebo)

PLACEBO COMPARATOR

Serum (placebo)

Other: Cosmetic product

Interventions

Cosmetic productOTHER

Apply on the face twice a day

Serum (placebo)Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Pharmaceutical Sciences, Universiti Sains Malaysia

Pulau Pinang, 11800, Malaysia

Location

Related Publications (16)

  • 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: 17507086BACKGROUND

  • 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: 22298568BACKGROUND

  • 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: 10955281BACKGROUND

  • 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: 24394657BACKGROUND

  • 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: 8399214BACKGROUND

  • 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: 9013880BACKGROUND

  • 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: 9214574BACKGROUND

  • 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.

    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.

    PMID: 15556719BACKGROUND

  • 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.

    PMID: 30272862BACKGROUND

  • 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.

    PMID: 20690482BACKGROUND

  • 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.

    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.

    PMID: 35902934BACKGROUND

  • Loh KC, Chan LC, Phang LF. Perceptions and psychosocial judgement of patients with acne vulgaris. Med J Malaysia. 2020 Jan;75(1):18-23.

    PMID: 32008014BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Cosmetics

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and Agriculture

Study Officials

  • Choon Fu Goh, PhD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

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 10, 2023

First Posted

March 6, 2023

Study Start

February 15, 2023

Primary Completion

November 16, 2023

Study Completion

November 16, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)