An application of H Bio-Juven Plantolin Skin Balm in eczema and psoriasis treatment

Clinical Trial SBS10899
Prepared by scientist Ms. Eva Kierzkowska, M.Pharm., GDHM

Clinical Trial SBS10899
Executive Summary

This white coat in vivo clinical trial follows the published anti-inflammatory experiment (attached) evaluating the potential of the Plantolin extract to inhibit alpha-2-phospholipase enzyme since it is known that activation of this enzyme causes inflammation. In this case an extract at a concentration of 0.025% sesquiterpene lactones showed to be as active as a preparation of Caribbean Gorgonias of the genus Pseudopterogorgia containing 0.06% pseudopterosins which possess a well proven and patented anti-inflammatory effect.

An application of H Bio-Juven Plantolin Skin Balm in eczema and psoriasis treatment
Prepared by scientist Eva Kierzkowska, M.Pharm, GDHM

ABSTRACT
The present study was undertaken to determine the effect of H Bio-Juven Plantolin Skin Balm in eczema and psoriasis treatment. The study was performed on humans. Two groups of 121 eczema and 67 psoriasis sufferers were asked to apply H Bio-Juven Plantolin Skin Balm 2 times per day over a 4 week period. With 19 of the subjects both conditions eczema and psoriasis were present. Before commencement of the trial medical history of subjects was recorded, including reports on diagnosis of skin conditions to ascertain eczema, psoriasis or other dermatological conditions. Volunteers were asked to describe their disease symptoms on 5-point scale before the trial and at the end of each week. Pre-treatment and post treatment photographs were taken, as well as at weekly intervals for the duration of the trial. Trial participants were advised to modify their diet slightly and incorporate small changes in regards to environmental factors, although this was not compulsory. It was concluded that H Bio-Juven Plantolin Skin Balm displayed therapeutic benefits in relieving the effects of eczema in 71.9% of cases, and psoriasis in 76% cases within the 4-week trial period. These findings suggest the use of H Bio-Juven Plantolin Skin Balm is an effective natural treatment for these dermatological diseases. Most interesting were the findings that majority of subjects demonstrated very severe or severe symptoms of these conditions, and despite maintaining same diet and lifestyle, measurable positive results were documented within the first week of using H Bio-Juven Plantolin Skin Balm.

INTRODUCTION
Eczema and psoriasis affect over one million Australians. Eczema/dermatitis is a common skin disorder characterised by an inflammatory epidermal rash, acute or chronic, redness, weeping, scaling and itch. Dermatitis can be divided into exogenous causes (allergic contact or primary irritant) and endogenous, which implies all forms of dermatitis not directly related to external causative factor. Endogenous types are atopic. This term refers to a hereditary background or tendency to develop one or more of group of conditions such as allergic rhinitis or asthma. There is no single cure for eczema but some conventional medications such as aqueous cream, emollients, topical corticosteroids and oral antihistamines and systemic corticosteroids have found the application.

Psoriasis is a chronic skin disorder, which affects 2-3% of the population. It appears most often between the ages of 10 and 30, although its onset can occur any time from infancy to old age. The feature of psoriasis is overproduction of skin cells leading to thickening of the skin and overcalling. There are many treatment options in psoriasis. Topical therapy includes dithranol, corticosteroids, tar preparations and emollients. In systemic therapy methotrexate and cyclosporin has found the application. Psoriasis treatment also includes physical therapy: ultraviolet light and photochemotherapy: psolaren plus ultraviolet light. Sometimes intralesional corticosteroids in treatment of isolated plaques are given.

All available eczema and psoriasis treatment options have many side effects, which often force the patient to stop a therapy.

The objective of this clinical trial was to study the effectiveness of H Bio-Juven Plantolin Skin Balm, which is a natural topical application without known side effects. The main active ingredient of H Bio-Juven Plantolin Skin Balm is a patented herbal extract from an Australian plant called Centipeda cunninghamii, which is also commonly known as "sneezeweed" or "old man's weed". This native Australian plant has been historically used by Aborigines for burns, wounds and skin infections (1). In Chinese traditional medicine the plant has been used to treat colds, nasal allergies, viral infections and asthma (2)(3)(4). Centipeda Cunninghamii belongs to the Daisy Family (Asteraceae, Compositae). It is an aromatic perennial herb about 30cm high, with quite woolly young shoots. Stem is green, cylindrical; leaves are oblong-ovate. Odour is characteristic, aromatic; taste slightly bitter. The flower heads are small and greenish. The herbal extract known in Australia as Plantolin, has been patented (USA patent No. 5,804,206) as Phytoplenolin in collaboration between the Australian company Plantolin Australia Pty Ltd, and it's research partner Bio-Botanica Inc – a world leading herbal extractor based in New York, USA.

ln a published laboratory-scale study a unique holistically balanced plant extract (Plantolin) prepared by a special patented procedure displayed potent anti-inflammatory, antifungal and skin renewal properties.

Before exploring the effectiveness of Plantolin when used topically it was important to test its safety on human skin. Consequently an independent laboratory performed the appropriate biological studies. The test confirmed the safety of Plantolin. The 'Hen's Egg Test', utilising the chorioallantoic Membrane (HET-CAM) was performed. Plantolin at 10% concentration had practically no ocular irritation potential.

To test the anti-inflammatory activity, two further experiments were carried out:

1. In the first experiment, the extracts potential to decrease a chemically (lactic acid) induced erythemal response was evaluated. The test was performed on five carefully selected human subjects and the percentage reduction in erythema was measured. Plantolin at 0.2% concentration alleviated inflammation as much as a 1% hyaluronic acid which is a well known healing agent.
2. In the second anti-inflammatory experiment the potential of the extract to inhibit alpha-2-phospholipase enzyme was evaluated since it is known that activation of this enzyme causes inflammation. In this case an extract at a concentration of 0.025% sesquiterpene lactones showed to be as active as a preparation of Caribbean Gorgonias of the genus Pseudopterogorgia containing 0.06% pseudopterosins which possess a well proven and patented anti-inflammatory effect.

In the next clinical experiment the possible healing effect of Plantolin extract was examined. Six human subjects were selected in order to evaluate these properties using a test with Dansyl chloride. The preparation of Plantolin was compared to a standard 2% alpha-hydroxy-acid lotion (known to be a potent cell renewal agent). The test has shown that Plantolin is very effective as a cell renewal agent at comparatively very low concentration without the drawbacks of the drastic exfoliating and caustic effect of the alpha-hydroxy-acids.

The efficacy of Plantolin as a sunscreen product was tested on five selected human subjects. The Sun Protector Factor was determined taking a preparation of 8% Homosalate (SPF=4.0) as standard. Plantolin preparation gave an average SPF=1.68.

In other experiments Plantolin antihistaminic, antifungal, antiviral and sunscreen properties were demonstrated (5)(6)(7). These facts have encouraged researchers to prepare a convenient form of topical application combining Plantolin with other natural ingredients to potentate the action. The results obtained in the study in 188 volunteers are reported.

MATERIAL AND METHODS
Volunteer's sample of 121 eczema and 67 psoriasis sufferers were recruited from the Melbourne community. The ages of the volunteers ranged from 3 months to 80+ years. Before commencement of the trial medical history of subjects was recorded, including reports on diagnosis of skin conditions to ascertain eczema, psoriasis or other dermatological conditions. All trial participants received a special booklet with directions on using H Bio-Juven Plantolin Skin Balm with some recommendations in regards to dietary modifications and environmental factors. * During 4-weeks trial volunteers were advised to apply H Bio-Juven Plantolin Skin Balm 2 times per day (once in the morning and once before bed). They were asked:

1. to wash affected skin area with H Bio-Juven Plantolin Bio-Soap
2. to dry affected skin area and apply H Bio-Juven Plantolin Skin Balm

All steps were repeated 2 times per day. Those volunteers who had extremely dry skin were advised to use H Bio-Juven Plantolin Moisturiser as desired.

Dietary modifications were suggested but not compulsory. The recommendations were as follows;

1. 4-5 small meals per day instead of fewer big meals
2. reduction of soft drink products and others containing preservatives, artificial colours and flavours, dairy products (excluding fermented milk products), oranges, tomatoes, and eggs
3. increased consumption of fruit and vegetables
4. increase fluid intake , preferably spring water or fruit and vegetables juices

The booklet has raised some issues relating to the type of clothes to wear and environmental factors. Avoiding the following was recommended;

1. synthetic clothing and rough wool
2. detergents, chemical disinfectants, perfumes, conventional soap
3. chlorinated water, sweating and rapid temperature changes
4. excessive 'unhealthy' stress

Dietary modifications, type of clothes to wear and environmental changes were not compulsory, but rather a guidance/advice. Some volunteers implemented those only convenient for them, whilst others did not change their normal dietary and lifestyle routine at all.

*Booklet available from authors

Before trial and at the end of every week all participants were asked to record severity of dryness and inflammation in case of eczema and inflammation and scaling in case of psoriasis on the 5-point scale. The 5-point scale was as follow:

1 - symptoms not present

2 - very mild symptoms

3 - mild symptoms

4 - severe symptoms

5 - very severe symptoms

The recorded severity of features of eczema and psoriasis were confirmed with a photo taken by the participants.

RESULTS

Most participants has described their condition before a trial on a 5-point scale as a very severe or severe. The details are given in table 1

Table 1

Number and percent of volunteers with a very severe or severe features of eczema before trial:

Number and percent of volunteers with a very severe or severe features of psoriasis before trial

Eczema
A total of 121 results (94 adults and 27 children) were collected from the study subjects. In table 2 it can be seen that 73.4% of adults and 66.6% of children have achieved improvement after a 4-week trial in dryness and inflammation or in one feature at least. Furthermore, 78.8% from those who have improved have achieved good results in both – dryness and inflammation. Percentage of positive results was slightly higher in adults than in children. There were 28.1% of subjects who did not observe improvement or who's condition worsened and choose not to continue. This percentage was higher in children. From a therapeutic perspective, it is normal for some to experience a worsening of the condition before it improves, due to the products' healing and antifungal properties and actions. However, with all products there's an allowance for subjects who may respond negatively, or who may experience ongoing adverse effects. In the case of H Bio-Juven Plantolin, such incidence has shown to be comparably low. 

Table 2

Number and Percentage of volunteers who observed improvement and those whose condition did not improve or worsened:

H Bio-Juven Plantolin Skin Balm has shown to be quick acting preparation. Most of participants could notice improvement after first and second week of treatment. The graph below shows the number and the percentage of people who improved after the first, second, third and fourth week.

[  C H A R T ]

Psoriasis
A total of 67 results (64 adults and 3 children) were collected from study subjects. The results are shown in table 3. 77% of adults and 66% of children have achieved improvement in both - inflammation and scaling or in one of the features of psoriasis at least. 74.5% from those who have notice improvement have achieved good results in inflammation and scaling at the same time. Positive results were slightly higher in adults than in children. 

Table 3

Number and Percentage of volunteers who observed improvement and those whose condition did not improve or worsened:

Similar to eczema most people with psoriasis could notice an improvement after the first and second week of treatment. The graph below shows the number and the percentage of people with improvement after the first, second, third and fourth week.

[  C H A R T ]

DISCUSSION
This study represents the first large-scale clinical trial to document the in vivo effect of H Bio-Juven Plantolin Skin Balm containing Plantolin in eczema and psoriasis treatment. The results strongly suggest that Plantolin can be successfully used in eczema and psoriasis treatment. This was to be expected, since a previous laboratory-scale experiments have shown potent anti-inflammatory and skin renewal properties. The results above 70% success rate can be recognised as excellent if we consider that eczema and psoriasis are very resistant to any treatment and often incurable. Most trial participants have observed improvement in eczema or psoriasis after first and second week of use, which qualifies H Bio-Juven Plantolin Skin Balm as quick acting remedy, for fast relief. In some people (5 with eczema and 1 with psoriasis) the condition worsened after the first week before it started to improve. This pattern of healing has been observed earlier and gives evidence that continued application of H Bio-Juven Plantolin Skin Balm, despite initial worsening of the condition, can eventuate in a positive therapeutic result. The results look particularly promising as most volunteers have described their symptoms as very severe or severe before trial and very few if any dietary or environmental changes had been made by the majority. Furthermore dietary modifications are long term measures that need to be adopted. In many cases it would require many months of stringent a dietary regime to notice benefits. Based on the results, it is the conclusive opinion of the researchers that the benefits from the relief of the symptoms of eczema, psoriasis, as well as other dermatological conditions were predominantly the direct result of the therapeutic properties present in H Bio-Juven Plantolin Skin Balm, and the key active patented ingredient Plantolin.

TESTIMONIALS
Although testimonials were not requested, some trial participants were compelled to express their feelings to H Bio-Juven Plantolin. There are some examples of testimonials we have received upon completion of the trial (originals attached).

"Compared to the long term side effects of traditional medication, I cannot thank you enough for allowing me to participate on the trial. I no longer hide my hands and elbows and knees with embarrassment."

Debra Forrest

"I have been to 2 doctors who gave me the normal Cortisone based creams and various shampoos. I tried these without success or improvement. After 4 weeks on your program I could see a big improvement and feel much better. I don't have the same itchiness or redness"

Tony Sammut

"My son Mark is 15 and suffers from eczema, and there has been an overall great improvement in his condition, especially the eczema on his back has almost disappeared."

M. Alderuccio

The feedback in regards to H Bio-Juven Plantolin Skin Balm's effectiveness, ease of application, smell and absorption was very positive, however in some cases with skin sensitivity liquid form was suggested. H Bio-Juven Plantolin scientists are currently developing this. The findings of this trial give firm evidence that the naturally based, drug free product H Bio-Juven Plantolin is an effective, quick acting remedy for eczema and psoriasis.

CONCLUSION
The scientists and brand owner are not claiming H Bio-Juven Plantolin Skin Balm to be a cure for sufferers of eczema, psoriasis and other skin problems. However, the statistical results for this in vivo white coat clinical trial shows some promising results. Over 70% of subjects, some who'd exhausted orthodox medicine and many other avenues, experienced relief from the product within the first week of use and continued improvement thereafter. This success rate exceeds some drug medicines such as cortisone cream where only a 40% success rate has been recorded.

This clinical trial does confirm that sufferers of eczema, psoriasis and other skin problems can benefit from the use of H Bio-Juven Plantolin Skin Balm which has been clinically proven to have anti-inflammatory, anti-fungal and skin renewal properties. As it has also been demonstrated, in some cases sufferers can expect a total recovery from the condition. The researchers are also of the view that, as a long-term measure for remedying skin disorders, even better results can be achieved when dietary and environmental modifications are implemented. There is no substitute for a healthy lifestyle. The biggest benefit that this natural H Bio-Juven Plantolin Skin Balm delivers are the medicinal skin healing benefits equal to other drug alternatives, without the side effects associated with the drug equivalents including the common cortisone creams.

ACKNOWLEDGMENT
H Bio-Juven and Plantolin Australia would like to thank all the volunteers, researchers and the rest of the scientific and administrative team for their participation and contribution towards this skin research program.

CORPORTATE PROFILE AND FURTHER RESEARCH & CLINICAL STUDIES
H Bio-Juven and Plantolin are the two Australian companies, who formed a partnership in the late 1980's to research, develop and market natural medicines of Australian origin. Both companies are privately owned by Australians, with a national team of 280 people. In the research field, the company is involved with some of the world's leading experts including Australia's Professor Avni Sali (Head of Swinburne University's Faculty for Integrative medicine), the global Henkel Pharmaceutical company (now known as Cognis), and the Consumer Product Testing company based of the United States. H Bio-Juven is affiliated with one of Australia's leading vitamin brands called Swisse Vitamins. Swisse and H Bio-Juven have a distribution alliance with Australia's leading pharmaceutical company's, namely Sigma Company and Faulding Health Care. Over the next 3 year period, Swisse H Bio-Juven have pledged an investment of 3 million dollars in further clinical trials, some with the assistance of the global research company Quintiles.

Swisse H Bio-Juven and Plantolin have also invested in farming resources to grow Plantolin locally for worldwide demands. Additional to the 20-acre farm in Lakes Entrance, a recent acquisition was finalised for another farm in Cranbourne, Victoria.

H Bio-Juven Plantolin are also developing the export market for the products with negotiations currently progressing in the United States, Japan and the Middle East (United Medical Group – UMG).

REFERENCES

1. A. Campbell, Aust. J. Pharm., 54,894 (1973-74)

2. J.B. Wu, Y. T. Chun, Y. Ebizuka and U. Sankawa, Chem. Pharm. Bull., 39 (12), 3272 (1991)

3. H. Lee and J.Y.Lin, Mutat. Res., 204 (2), 229 (1988)

4. Y. C. Lin, T. I. Yang and C.S. Yang, Chin. J. Microbiol., 6,97 (1973)

5. Frank D'Amelio,Sr. and Youssef W. Mirhom, "Phytoplenolin – a natural product". New York

6. D. M. Wiesner, The Austr. J. of Pharm. 785,57,1996

7. EML Consulting Services Pty Ltd "Antifungal properties of Plantolin" - 1997