Topical Palm Tocotrienols on Blemish-prone Skin

Acne Clinical Trial

Official title:

A Randomised Double-blind Placebo-controlled Study on the Effects of Topical Palm Tocotrienols on Blemish-prone Skin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05756881
• Other study ID #: MA-T3-T3
• Status: Terminated
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: November 16, 2023

Study information

• Verified date: November 2023
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The effects will be observed during the 12-weeks of use.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Healthy individuals, aged 18 years and above

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:

1. Has a history of chronic drug or alcohol abuse

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

Related Conditions & MeSH terms

• Acne

Intervention

Other:
• Cosmetic product
Apply on the face twice a day

Locations

Country	Name	City	State
Malaysia	School of Pharmaceutical Sciences, Universiti Sains Malaysia	Pulau Pinang

Sponsors (3)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	Avantsar Sdn. Bhd., Malaysia Palm Oil Board

Country where clinical trial is conducted

Malaysia, 

References & Publications (16)

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.

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.

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. — View Citation

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. — View Citation

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.

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. — View Citation

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

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Zouboulis CC. Acne and sebaceous gland function. Clin Dermatol. 2004 Sep-Oct;22(5):360-6. doi: 10.1016/j.clindermatol.2004.03.004. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The percent change from baseline in global face total lesion count.	Acne lesion count	18 Week
Secondary	Acne lesion counts for the total global face and total lesion counts	Acne lesion count	18 Week
Secondary	CASS assessment	Comprehensive Acne Severity Scale (CASS)	18 Week
Secondary	Survey (CADI)	The Cardiff Acne Disability Index 2021	18 Week
Secondary	The percent change from baseline in sebum, skin pH, hydration and erythema index	Skin probe	18 Week