Introducing Adjuvia Bed Sore Cream FAQ and Technical References

Adjuvia Bed Sore Cream brings a novel treatment to bed sores, injuries, poison ivy, burns and skin rashes that for the first time addresses the true etiology of these maladies. This patented high bioavailability, lipid rich nano emulsified astaxanthin Adjuvia Bed Sore Cream is both a healing and an antimicrobial agent.

Wounds go through several progressive stages in the process of healing. For instance, in a burn, the tissue damage can increase for up to a week before healing begins. During this time there are strong inflammatory processes and “cleaning” that takes place. Healing begins after the inflammation stage has finished, puss is cleaned up, exemplified by the elimination of the foul smell. Highly bioavailable astaxanthin facilitates both processes.

In their paper, Oxidative stress and acute-phase response in patients with pressure sores Bernarda et al (Nutrition, Volume 21, Issue 9, September 2005, Pages 901-90) report:

“Patients with pressure sores and acute infection present a systemic inflammatory response accompanied by an increase in lipid peroxidation that is associated with decreased serum ascorbic acid and α-tocopherol levels, suggesting that these patients may be at risk for important nutritional deficiencies.”

Those who suffer from pressure or bed sores, also generally suffer from mitochondrial dysfunction. The healing mechanisms are part of the immune system, and the failure of the immune system to operate in a healthy way leads to chronic conditions including pressure sores. Mitochondrial dysfunction can be ameliorated by administering an anti-microbial which is an adjuvant targeting the mitochondria and mitigating ROS. To treat bed sores successfully it is necessary to clean the wound at the cellular level, to boost mitochondrial function and the immune system, and regulate the inflammatory/anti-inflammatory cycles that characterize immune function.

Adjuvia Bed Sore Cream is designed and manufactured under cGMP practices to target active materials such as highly bioavailable lipid rich nano emulsified astaxanthin which acts at the same time and in the same cellular spaces as a powerful anti-microbial, to clean the wound, eliminate the smell, eliminate the puss oozing and act as a powerful adjuvant to advance the healing process by enabling the mitochondrial system to function at a high energy supplying function while at the same time protecting many constituents from ROS induced destruction.

While all the literature and science below provides the foundation for designing, making and using Adjuvia Bed Sore Cream, the most important evaluation is using it and seeing the accelerated healing.

The first thing one can expect in treating a bed sore with Adjuvia Bed Sore Cream is that after 4-7 days, puss flow should slow down and stop, and the foul order will diminish and disappear. This is due to the strong anti-microbial power of astaxanthin in Adjuvia Bed Sore Cream. At the same time, the astaxanthin is powering up the cells to begin healing.

Then after another week one will observe signs of healing, which can go on for several weeks. This is a new phenomenon, based on a new scientifically sound technology and product. But the observant practitioner will have many questions, which need to be addressed with credible answers. Among the questions we are asked are these:

1) Is it safe, and is safety based on credible data and certifications? Adjuvia Bed Sore Cream is generally recognized as safe, based on judgements made by the FDA and other agencies.

2) Is there proof of the anti-microbial behavior? What is the mechanism? There are several powerful active materials in Adjuvia Bed Sore Cream, well characterized in the scientific literature.

3) Is there proof of the healing and anti-microbial properties of astaxanthin? The power of astaxanthin to boost the mitochondria and immune function is widely reported and justified in the peer-reviewed, scientific literature.

4) What are the active materials and what do they do? We report here on all the active materials and their roles and functions from the peer-reviewed literature.

5) What are the inactive materials and what do they do. We report here on all the inactive materials and their roles and functions from the peer-reviewed literature.

6) Can it be used with latex and nitrile gloves? The latex and nitrile glove industry has widely tested these materials and reported on their use with all these materials which is referenced.

This paper is structured into three parts:

a) We offer an introduction to astaxanthin, mitochondrial function and the immune system and the progression and vulnerability to pressure sores.

b) We have constructed a table addressing all of the issues associated with the ingredients in Adjuvia Bed Sore Cream

c) We offer references and citations for each of these topics which are addressed in our table:  Safety, Efficac, Nitrile and Latex, Active material function and Adjuvant function

Overview:

The National Pressure Injury Advisory Panel (https://npiap.com) reports these statistics on Pressure sores:

  •  60,000 avoidable deaths per year
  •  2.5 million cases per year
  •  25.2% of patients in Long Term Acute Care suffer from pressure sores
  • 12% of patients in rehab facilities suffer from pressure sores
  • 11.8%, (some reports 28%) in nursing homes suffer from pressure sores
  • 9.75% of patients in acute care suffer from pressure sores.

We observe:

  • About 1.5 million patients reside in nursing homes
  • Up to 31% of Hospice Care patients can  sufferer from bed sores, and two thirds of these are treated at home
  • Age group%Population by ageUnder 650.155217,000 65-740.165231,000 75-840.264369,600 85-940.338473,200 over 950.078109,200 1.001,400,000

    We observe that the etiology of most modern chronic diseases are due to the unmitigated production of reactive oxidative species (ROS) by the mitochondria. As this process progresses over time, it
  • Diminishes the power of mitochondria to reproduce,
  • Diminishes the production potential of the mitochondria to make energy, which is needed for immune function
  • The ROS destroys important constituents and enzymes required for making energy, particularly the enzyme CoQ 10
  • The ROS destroy important metabolic molecular constituents, many of which are critical to both the lymphatic and eicosanoid based immune systems, including taurine, arachidonic acid, selenium, magnesium, zinc, iron, and others.
  • This diminished immune response and retarded wound healing sets up conditions for long term infection which further inhibits the healing process, exemplified by a malodor and puss
  • So to treat bed sores, we first need to clean up the infections and then fuel energy and constituents so the immune system can function effectively to heal the wound.
  • Adjuvia Bed Sore Cream provides the active and inactive ingredients to enable this process.
  • We believe we are the first to trace this etiology from its actual source and the first to design a treatment to solve the problem.
  • Seeing is believing, and within a few weeks of use of Adjuvia Bed Sore Cream, its efficacy will be apparent. Here is a table answering some of the questions that you might have about Adjuvia Bed Sore Cream’s safety and efficacy.

References and Citations

Safety

1) Bees Wax: Drugs A-Z Pill Identifier Supplements Symptom Checker Diseases Dictionary

2) Beeswax Freeman MSDS

3) FDA Sec. 184.1973 Beeswax (yellow and white).

4) Calcium disodium EDTA Code of Federal Regulations Title 21, Volume 3 Revised as of April 1, 2019 CITE: 21CFR172.120]

5) Safety Assessment of Iodopropynyl Butylcarbamate as Used in Cosmetics Cosmetic Ingredient Review 1101 17TH STREET, NW, SUITE 412 ◊ WASHINGTON, DC 20036-4702 ◊ PH 202.331.0651 ◊ FAX 202.331.0088 ◊ CIRINFO@CIRSAFETY.org

6) Carbomer: Medically reviewed by Drugs.com. Last updated on Apr 13, 2020.

7) Cetearyl Alcohol JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 7, Number 3, 1988 Mary Ann Liebert, Inc., Publishers

8) Dimethicone: Product Uses and Side Effects https://thedermreview.com/dimethicone/

9) Safety Assessment of EDTA & Salts as Used in Cosmetics Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ cirinfo@cir-safety.org

10) FDA on mineral oil: Reference ID: 3481551

    • Mineral oil is an inert, chemically stable ingredient, with a long history of safe use in common topical applications. FDA permits the use of mineral oil as an active ingredient in some over-the-counter (OTC) drug product categories, including anorectal drugs, skin protectants and ophthalmic moisturizers. In addition, the FDA regulates mineral oil as a multipurpose direct food additive with specific purposes, such as in the manufacture of yeast used to make bread, or to keep dust from adhering to some grains.
    • The Cosmetic Ingredient Review (CIR), an independent expert scientific panel established by the Personal Care Products Council, also has evaluated the scientific data and concluded that mineral oil is safe for use as a cosmetic ingredient at the current concentrations of use.
    • The Cosmetics Directive of the European Union allows the use of mineral oil in cosmetics and personal care products with no listed restrictions

      11) Astaxanthin: Multiple GRAS rulings on astaxanthin extracted from Haematococcus pluvialis for human use.

      12) Final Report on the Safety Assessment of Glyceryl Stearate JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 1, Number 4, 1982 Mary Ann Liebert, he., Publishers

 

13) Glycerin: FDA Sec. 184.1324 Glyceryl monostearate.

14) Glycerin: FDA: Glycerin as a food additive is Generally Recognized As Safe (GRAS) US Food and Drug Administration (FDA) SCOGS (Select Committee on GRAS Substances) US Food and Drug Administration

15) Diazolidinyl Urea Prepared for NCI to support chemical nomination by Technical Resources International, Inc. under Contract No. N02-CB-07007 (09/03; 08/04)

16) Diazolidinyl Urea JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 9, Number 2,1990 Mary Ann Liebert, Inc., Publishers

17) Iodopropynyl Butylcarbamate Safety Assessment of Iodopropynyl Butylcarbamate as Used in Cosmetics Cosmetic Ingredient Review 1101 17TH STREET, NW, SUITE 412 WASHINGTON, DC 20036-4702 PH 202.331.0651 FAX 202.331.0088 CIRINFO@CIRSAFETY.ORG

18) Isopropyl myristate PubMed CIDs PubChem records 8042

19) Lavender oil is on the list of Essential oils considered generally safe by FDA are known as GRAS

20) Dimethicone Cosmetic Ingredient Review Safety Assessment of Dimethicone 1620 L Street, NW, Suite 1200 Washington, DC 20036-4702 ph 202.331.0651 fax 202.331.0088 cirinfo@cir-safety.org

21) Methylparaben Excipient (pharmacologically inactive substance) Medically reviewed by Drugs.com. Last updated on Sep 15, 2018.

22) Aloe Vera: The NCCIH clearing house: There’s some evidence that the topical use of aloe products might be helpful for symptoms of certain conditions such as psoriasis and certain rashes. Historically, aloe vera has been used for a variety of purposes, including treatment of wounds, hair loss, and hemorrhoids. Two substances from aloe vera, the clear gel and the yellow latex, are used in health products today. Aloe gel is primarily used topically (applied to the skin) as a remedy for skin conditions such as burns, frostbite, psoriasis, and cold sores. The NCCIH Clearinghouse provides information on NCCIH and complementary and integrative health approaches, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

23) Parabens: FDA: FDA scientists continue to review published studies on the safety of parabens. At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health.

24) Petrolatum FDA GRAS Sec. 172.880 Petrolatum

25) Propylene Glycol FDA GRAS Sec. 184.1666 Propylene glycol

26) Propylparabehn FDA GRAS Sec. 184.1670 Propylparaben.

27) Safety Assessment of Iodopropynyl Butylcarbamate as Used in Cosmetics Cosmetic Ingredient Review 1101 17TH STREET, NW, SUITE 412 WASHINGTON, DC 20036-4702 PH 202.331.0651 FAX 202.331.0088 CIRINFO@CIRSAFETY.ORG

28) Stearic Acid FDA GRAS Sec. 184.1090 Stearic acid

Efficacy, Active material functions, and Adjuvant function

1) Astaxanthin protects against early burn-wound progression in rats by attenuating oxidative stress-induced inflammation and mitochondria-related apoptosis, 2017 Fang et al Scientific Reports | 7:41440 | DOI: 10.1038/srep41440

2) Effect of astaxanthin on cutaneous wound healing, Meephansan et al 2017 Clinical, Cosmetic and Investigational Dermatology 2017:10 259–265

3) Astaxanthin in Skin Health, Repair, and Disease: A Comprehensive Review, 2018 Davinelli et al Nutrients 2018, 10, 522; doi:10.3390/nu10040522

4) Astaxanthin-alpha tocopherol nanoemulsion formulation by emulsification methods: Investigation on anticancer, wound healing, and antibacterial effects 2018 Shanmugapriya et al Colloids and Surfaces B: Biointerfaces Volume 172, 1 December 2018, Pages 170-179

5) Antimicrobial Activity of Six Essential Oils Against a Group of Human Pathogens: A Comparative Study, 2019 Man et al Pathogens 2019, 8, 15; doi:10.3390/pathogens8010015

6) Essential Oils as Antimicrobial Agents—Myth or Real Alternative? 2019 Win´ska et al Molecules 2019, 24, 2130; doi:10.3390/molecules24112130

7) Antioxidant and antimicrobial activities of astaxanthin from Penaeus monodon in comparison between chemical extraction and High-Pressure Processing (HPP), 2017 Jaswir et al International Food Research Journal 24(Suppl): S508-S513 (December 2017)

8) Mitochondrial Function in Immunity and Disease, Tiku et al 2020 Trends in Cell Biology, April 2020, Vol. 30, No. 4

9) Mitochondrial Dysfunction and Immune Cell Metabolism in Sepsis, 2017 Park et al. https://doi.org/10.3947/ic.2017.49.1.10 Infect Chemother 2017;49(1):10-2

10) Mitochondrial Dysfunction and the Aging Immune System, 2019 McGuire et al. Biology 2019, 8, 26; doi:10.3390/biology8020026

11) Mitochondrial Fact Sheet: Australian Mitochondrial Disease Foundation: https://www.mito.org.au/

12) Mitochondrial Metabolic Function Assessed In Vivo and In Vitro 2010 Lanza et al. Curr Opin Clin Nutr Metab Care. 2010 September; 13(5): 511–517. doi:10.1097/MCO. 0b013e32833cc93d.

13) Cell-based Measurements of Mitochondrial Function in Human Subjects, 2014 Kang et al Methods Enzymol 2014 542: 209–221. doi:10.1016/B978-0-12-416618-9.00011-X.

14) Current concepts in the diagnosis and management of cytokine release syndrome, 2017 Lee et al Blood First Edition paper, May 29, 2014; DOI 10.1182/blood-2014-05-552729

15) Autoimmune disease and mitochondrial dysfunction in chronic diseases, 2017 Martins et al. IJ Res Chron Dis (2017) 1(1), 010–0012

16) Antioxidant effects of astaxanthin in various diseases—a review, 2018 Ekpe et al JOURNAL OF MOLECULAR PATHOPHYSIOLOGY, 2018 VOL 7, NO. 1, PAGE 1–6 10.5455/jmp.20180627120817

17) Mitochondria as a centrally positioned hub in the innate immune response, 2017 Sandhir et al Biochimica et BiophysicaActa 1863 (2017) 1090–1097

18) Astaxanthin intake significantly increased its deposit in plasma, and retained glutathione content, reduced the production of reactive oxygen species” (Chan KC, Pen PJ, Yin MC. Anticoagulatory and anti-inflammatory effects of astaxanthin in diabetic rats. J Food Sci. 2012 Feb;77(2):H76-80. doi: 10.1111/j.1750-3841.2011.02558.x. Epub 2012 Feb 6. PMID: 22309505)

19) Mitochondrial activity in T cells, 2018 Desdín-Mico et al http://dx.doi.org/10.1016/j.mito.2017.10.006

20) The Effect of Astaxanthin on Glutathione Levels in Damaged Liver Tissues of Male Wistar Rats Induced By Oral Formaldehyde, 2019 Andriani et al 10.18502/kls.v4i12.4168

21) The essential role of mitochondrial dynamics in antiviral immunity, 2018 Kim et al https://doi.org/10.1016/j.mito.2017.11.007 Mitochondrion

22) Astaxanthin: A mechanistic review on its biological activities and health benefits, 2018 Fakhria et al https://doi.org/10.1016/j.phrs.2018.08.012

23) Astaxanthin, a Carotenoid, Stimulates Immune Responses by Enhancing IFN-γ and IL-2 Secretion in Primary Cultured Lymphocytes in Vitro and ex Vivo, 2015 Lin et al Int. J. Mol. Sci. 2016, 17, 44; doi:10.3390/ijms17010044

24) ASTAXANTHIN: A POTENTIAL CAROTENOID, 2012 Dhankhar et al., IJPSR, 2012; Vol. 3(5): 1246-1259

25) Scientific Opinion on the substantiation of health claims related to astaxanthin and protection of the skin from UV-induced damage (ID 1687, 1979), defense against Helicobacter pylori (ID 1686), contribution to normal spermatogenesis (ID 1688), contribution to normal muscle function (ID 1685), and “immune system” (ID 1689, 1919, 1980) pursuant to Article 13(1) of Regulation (EC) No 1924/20061 EFSA Journal 2011;9(6):2206

26) On the Neuroprotective Role of Astaxanthin: New Perspectives? 2018 Galasso et al. Mar. Drugs 2018, 16, 247; doi:10.3390/md16080247

27) The Role of Food Antioxidants, Benefits of Functional Foods, and Influence of Feeding Habits on the Health of the Older Person: An Overview, 2018 Wilson et al Antioxidants 2017, 6, 81; doi:10.3390/antiox6040081

28) McCall B, McPartland CK, Moore R, Frank-Kamenetskii A, and Booth BW. Effects of astaxanthin on the proliferation and migration of breast cancer cells in vitro. Antioxidants 2018, 7, 135; doi:10.3390/antiox7100135

29) Fassett, R.G.; Coombes, J.S. Astaxanthin, oxidative stress, inflammation, and cardiovascular disease. Future Cardiol. 2009, 5, 333–342.

30) Grimming B, Kim S, Nash K, Bickford P, Shytle R. Neuroprotective mechanisms of astaxanthin: a potential therapeutic role in preserving cognitive function in age and neurodegeneration. GeroScience. 2017, 39: 19-32.

31) Fakhri S, Aneva I, Farzaei M, Sobarzo-Sánchez E. The Neuroprotective Effects of Astaxanthin: Therapeutic Targets and Clinical Perspective. Molecules. 2019, 24, 2640.

32) Ambati RR, Phang S-M, Ravi S, Aswathanarayana RG. Astaxanthin: sources, extraction, stability, biological activities and its commercial applications – a review. Marine Drugs. 2014, 12:128-152.

33) Grimming B, Daly L, Hudson C, Nash KR, Bickford PC. Astaxanthin attenuates neurotoxicity in a mouse model of Parkinson’s disease. Functional Foods in Health and Disease. 2017, 7(8): 562-576.

34) Park J, Mathison B, Hayek M, Zhang J, Reinhart G, Chew B. Astaxanthin modulates age-associated mitochondrial dysfunction in healthy dogs. American Society of Animal Science. 2013, 91:268-275.

35) Ohgami K, Shiratori K, Kotake S, Nishida T, Mizuki N, Yazawa K, Shigeaki O. Effects of astaxanthin on lipopolysaccharide-induced inflammation in vitro and in vivo. Investigative Ophthamology & Visual Science. 2003, Vol 44, No. 6: 2694-2701.

36) Astaxanthin: A Potential Mitochondrial-Targeted Antioxidant Treatment in Diseases and with Aging, 2018 Sztretye et al Oxidative Medicine and Cellular Longevity Volume 2019, Article ID 3849692, 14 pages https://doi.org/10.1155/2019/3849692

37) Astaxanthin decreased oxidative stress and inflammation and enhanced immune response in humans, 2010 Park et al. Nutrition & Metabolism 2010, 7:18 http://www.nutritionandmetabolism.com/content/7/1...

38) Astaxanthin, Cell Membrane Nutrient with Diverse Clinical Benefits and Anti-Aging Potential, 2011 Kidd et al. Alternative Medicine Review Volume 16, Number 4

39) Astaxanthin decreased oxidative stress and inflammation and enhanced immune response in humans, 2018 Park et al Nutrition & Metabolism 2010, 7:18 http://www.nutritionandmetabolism.com/content/7/1...

40) Building strength, endurance, and mobility using an astaxanthin formulation with functional training in elderly, 2018 Liu Journal of Cachexia, Sarcopenia and Muscle 2018; 9: 826–833 Published online 26 September 2018

41) How mitochondria produce reactive oxygen species, 2009 MURPHY Biochem. J. (2009)417,1–13(Printed in Great Britain) doi:10.1042/BJ20081386

42) Free Radicals: Implications of Etiology of Chronic Diseases and their Amelioration through Nutraceuticals, 2015 Kalam et al Pharmacologia 2015 11 20

43) Identification of Carotenoids from Green Alga Haematococcus pluvialis by HPLC and LC-MS (APCI) and Their Antioxidant Properties, 2009 Rao et al J. Microbiol. Biotechnol. 19(11), 1333–1341 doi: 10.4014/jmb.0905.03007

44) Inhibitory Effect of Astaxanthin on Oxidative Stress-Induced Mitochondrial Dysfunction-A Mini-Review, 2018 SH Kim and H Kim Nutrients. 2018 Sep; 10(9): 1137

45) Mitochondria and Reactive Oxygen Species: Physiology and Pathophysiology, \ Bolisetty et al. 2013 Int. J. Mol. Sci. 2013, 14, 6306-6344; doi:10.3390/ijms14036306

46) Monogram: Mitochondrial Dysfunction, Nutrition and Aging, English September 2013

47) Oxidative Stress, Mitochondrial Dysfunction, and Aging, 2012 Cui, Kong, and Zhang Journal of Signal Transduction Volume 2012, Article ID 646354, 13 pages doi:10.1155/2012/646354

48) The Protective Role of Astaxanthin for UV-Induced Skin Deterioration in Healthy People—A Randomized, Double-Blind, Placebo-Controlled Trial, 2018 Ito Nutrients 2018, 10, 817; doi:10.3390/nu10070817

Nitrile and Latex

1) Durashield’s table for use of Latex Gloves: www.tsmfg,

2) https://superiorglove.com/blog/guide-to-chemical-resistant-gloves

3) http://amo-csd.lbl.gov/downloads/Chemical%20Resistance%20of%20Gloves.pdf

4) https://tchristy.com/wp-content/uploads/2015/11/CHEMREST-Guide_A772-SDS.pdf

5) http://www.dartmouth.edu/ehs/chemical/nitrile_gloves_chemical_resistance_guide.pdf

6) https://www.unisafegloves.com/chemical-resistance-guide