Skin Condition Clinical Trial
Official title:
The Effects of Rice Ceramide Supplementation in Improving Skin Health
Verified date | September 2022 |
Source | Nexus Wise Sdn Bhd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Ceramides have been added to newer cosmetic products to improve skin barrier function and exogenously replenish skin ceramides. Of the stratum corneum intercellular lipids, Ceramides are the most effective at restoring barrier function and increasing skin hydration. Different ceramides have been incorporated into cosmetic formulations, but understanding the differences between ceramides used in formulations, or even identifying ceramides in formulations can be complex. This is mostly because of an archaic nomenclature system that is fundamentally flawed based on current scientific evidence. In the recent past, due to the unique bioactive components of rice, it has been explored to a certain limit for its components. Further, much attention has been paid to the plant ceramide with its incorporation into cosmetics and food preparations owing to its safety in contrast to animal/synthetic origin. There are reports on plant ceramide deciphering its protective effects on human skin by preventing moisture loss. It has been anticipated that ceramides, fatty acids, and cholesterol in combination with hydrocortisone (HC) can be an useful therapeutic agents against xerosis and atopic dermatitis. The beneficial effects of oral intake of plant-derived ceramides for skin hydration and skin barrier reinforcement have been established in several studies involving animal models as well as human subjects. Ingestion of konjac ceramides has also shown positive effects in atopic dermatitis patients as well as healthy volunteers. Results showed improved skin symptoms and reduced skin allergic responses. The foregoing studies support the beneficial effects of oral intake of plant ceramides and their potential complementary and alternative therapeutic applications in the restoration and maintenance of skin barrier function. However, the findings from human study are still very limited, more detailed and comprehensive studies are still required to document the clinical efficacy of oral supplementation of ceramides. Thus, this study aims to evaluate the effects of rice ceramides consumption in improving skin health.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: - Good general health - Free from any skin diseases - Willing to comply with rice ceramide consumption plan - Willing to give consent Exclusion Criteria: - Undergoing medication plan for skin condition - Undergone major surgical procedures in the past six months - Pregnant or lactating woman |
Country | Name | City | State |
---|---|---|---|
Malaysia | UCSI University | Cheras | Kuala Lumpur |
Malaysia | Nexus Wise Sdn. Bhd. | Petaling Jaya | Selangor |
Lead Sponsor | Collaborator |
---|---|
Nexus Wise Sdn Bhd | JScience Consultancy PLT |
Malaysia,
Asai S, Miyachi H. [Evaluation of skin-moisturizing effects of oral or percutaneous use of plant ceramides]. Rinsho Byori. 2007 Mar;55(3):209-15. Japanese. — View Citation
Guillou S, Ghabri S, Jannot C, Gaillard E, Lamour I, Boisnic S. The moisturizing effect of a wheat extract food supplement on women's skin: a randomized, double-blind placebo-controlled trial. Int J Cosmet Sci. 2011 Apr;33(2):138-43. doi: 10.1111/j.1468-2 — View Citation
Henderson AJ, Ollila CA, Kumar A, Borresen EC, Raina K, Agarwal R, Ryan EP. Chemopreventive properties of dietary rice bran: current status and future prospects. Adv Nutr. 2012 Sep 1;3(5):643-53. doi: 10.3945/an.112.002303. Review. — View Citation
Heule F. An oral approach to the treatment of photodamaged skin: a pilot study. J Int Med Res. 1992 Jun;20(3):273-8. — View Citation
Imokawa G, Akasaki S, Hattori M, Yoshizuka N. Selective recovery of deranged water-holding properties by stratum corneum lipids. J Invest Dermatol. 1986 Dec;87(6):758-61. — View Citation
Kawano K, Umemura K. Oral intake of beet extract provides protection against skin barrier impairment in hairless mice. Phytother Res. 2013 May;27(5):775-83. doi: 10.1002/ptr.4792. Epub 2012 Sep 4. — View Citation
Kimata H. Improvement of atopic dermatitis and reduction of skin allergic responses by oral intake of konjac ceramide. Pediatr Dermatol. 2006 Jul-Aug;23(4):386-9. — View Citation
Miyanishi K, Shiono N, Shirai H, Dombo M, Kimata H. Reduction of transepidermal water loss by oral intake of glucosylceramides in patients with atopic eczema. Allergy. 2005 Nov;60(11):1454-5. — View Citation
Yeom M, Kim SH, Lee B, Han JJ, Chung GH, Choi HD, Lee H, Hahm DH. Oral administration of glucosylceramide ameliorates inflammatory dry-skin condition in chronic oxazolone-induced irritant contact dermatitis in the mouse ear. J Dermatol Sci. 2012 Aug;67(2):101-10. doi: 10.1016/j.jdermsci.2012.05.009. Epub 2012 Jun 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wrinkle change | To be assessed using Total Wrinkle Score (TWS). TWS has a minimum value of 4 and maximum value of 20, with higher values indicating higher severity. | Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3) | |
Primary | Change in skin firmness and elasticity | To be assessed using Courage & Khazaka Cutometer®, MPA580 | Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3) | |
Primary | Change in skin hydration | To be assessed using Courage & Khazaka Corneometer®, CM825 | Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3) | |
Primary | Change in transepidermal water loss and skin barrier function | To be assessed using Tewameter® TM 300 | Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3) | |
Primary | Change in skin whitening | To be assessed using Courage & Khazaka Mexameter®, MX18 | Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3) | |
Primary | Change in sebum secretion | To be assessed using Courage & Khazaka Sebumeter®, SM815 | Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3) | |
Primary | Change in skin pH | To be assessed using Courage & Khazaka pH meter®, PH900 | Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3) | |
Secondary | Adverse events | Monitor for adverse response from participants | Follow-up visit month 3 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06166342 -
Efficacy Evaluation of TCI153 Probiotics for Skin Beautification
|
N/A | |
Recruiting |
NCT06066151 -
The Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome
|
N/A | |
Completed |
NCT05619471 -
VIO Imaging for Skin Tissue Assessment (VISTA)
|
N/A | |
Completed |
NCT05311020 -
Efficacy Evaluation of Pitaya Ovule Extract on Skin
|
N/A | |
Completed |
NCT06194487 -
Efficacy Evaluation of Collagen Drink Products
|
N/A | |
Completed |
NCT04805697 -
Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory
|
N/A | |
Completed |
NCT04733872 -
Using Vegetable and Berry Products Can Improve Skin Conditions
|
N/A | |
Completed |
NCT04733859 -
Using Red Djulis Products Can Improve Skin Conditions
|
N/A | |
Completed |
NCT04878523 -
Investigation of the Efficacies of Multi Berries Juice on Anti Oxidant Effect and Improvement of Skin Conditions
|
N/A | |
Completed |
NCT05182814 -
Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid
|
N/A | |
Completed |
NCT05591352 -
Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
|
N/A | |
Completed |
NCT05988567 -
Efficacy Testing of Melon Oil Olive Pressed Candy Products
|
N/A | |
Recruiting |
NCT06157567 -
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
|
N/A | |
Terminated |
NCT01517178 -
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
|
Phase 3 | |
Withdrawn |
NCT01448629 -
Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
|
N/A | |
Completed |
NCT04878536 -
Efficacy Testing of Collagen Elixir
|
N/A | |
Completed |
NCT04996043 -
Efficacy Testing of Collagen Peptide Drink
|
N/A | |
Completed |
NCT04709588 -
Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition
|
N/A | |
Completed |
NCT04266405 -
Efficacy Testing of Collagen and Zhuyin Drinks
|
N/A | |
Recruiting |
NCT05277324 -
The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic
|