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Outstanding Results From Dr. Tirant Trial

April 11, 2012

OUTSTANDING RESULTS FROM DR. TIRANT TRIAL is taken from The PSORI Newsletter, Volume 38, December 95, The Psoriasis of Victoria Inc., P.O. Box 1151, Glen Waverley, Victoria, 3150, Australia – titled “Outstanding results from Dr. Tirant’s trial” (unedited.)

 

“DISCLAIMER: The Psoriasis Association of Victoria does not endorse this treatment or products as this would be unethical. This is purely the results of the trial.”

 

Our readers will have been following, with interest, the small progress notes included in our newsletter since five of our members undertook the opportunity to trial a Psoriasis treatment devised by Dr. Michael Tirant.

 

Dr. Tirant has been using his treatment for four and a half years now, with a high percentage of success, and was prepared to run the trial to show his confidence in his treatment and also his sincerity in wishing to help Psoriasis sufferers.

 

Our five members who took part are from diverse backgrounds, ages and sex. None had prior contact or knowledge of Dr. Tirant and entered the trial on the understanding they would provide written reports on their progress and outcome.

 

Each of the five have experienced momentous improvement in their condition. It can be said that they have been cleared of their condition during this trial period.

 

Five people would not be seen by health professionals as a sufficient indicator for viability of a treatment. There would normally be extensive trialling with double blind components, consistent monitoring and a large participant base, held over many months. Dr. Tirant is in private practice and can not support a trial of such magnitude, at this time.

 

The Association has considered these facts especially when we have taken the step to share the results of such a limited trial with our readers. We have based our decision to print as our experience with fellow sufferers has been that any product used by our members to date have not shown such a blanket response. Our expectation had been that if three people had shown improvement, then it would be viable, but to see all five respond so positively has been remarkable.

 

Naturally our association does not endorse this treatment, or product, as this would not be ethical but we can present you with the testimonials of the five participants.

 

(Names have not been included for privacy but the original letters will be available for personal inspection at our office during office hours for any reader who feels they wish to verify the authenticity.)

 

Dr. Tirant has provided the Association with his approach to treatment, which follows the testimonials.

 

M.N. Writes:

 

I started (Dr. Tirant’s trial) on July 12. I would say my Psoriasis has cleared up 85%, The remaining area is slow to respond, but will keep on and hope to get 100%. As you know no two people react the same, but I am happy with the results I have gained to date.

 

I am 69 years old and have had Psoriasis for 33 years.

 

L.S. Writes:

 

I would like to thank you for asking me to be under the trial of Dr. Tirant.

 

I started the trial around about August and was under his care for around eight weeks. When I first went there I had quite extensive Psoriasis around the groin area and under the armpits. As a result of his treatment the Psoriasis got progressively better each week until it was all gone with no set back at all.

 

I am currently clear of Psoriasis now and feel absolutely great. I think the ten glasses of water I have each day have a profound effect on the healing as well but I would like to say sometimes it gets pretty hard to keep drinking so much clear water. The other thing I would like to say is that I have lost quite a bit of weight through this process as well, which in my case is good.

 

I am not using any ointment at the moment as I am all clear, but just a few things I do each day are important to me.

 

I rise each day at 6 a.m. and go for a walk along the beach, as I live close by, this takes about 40 minutes.

 

Half an hour meditation each day.

 

Eat for nourishment and not for comfort, at least I try to, less fatty foods, less dairy foods.

 

Always try to look on the bright side of things.

 

I have never drunk or smoked mainly because it just never appealed to me.

 

Try to manage stress and not let it get on top of you but a little bit of worry doesn’t hurt you, it gives you discipline.

 

Never argue with people, if the situation is too bad remove yourself.

 

I am now fifty years old, I just got the Psoriasis when I was about 12 years old. I have had a terrible time with it as well, especially through my teen years.

 

I had a few really bad bouts of it, with about 70% cover a couple of times, one time I was so bad I thought of selling my real estate business and stopping work all together, thank god things became better again and the Psoriasis wasn’t so bad.

 

I do quite a lot of meditation, and I have done for 30 years, and I feel this holds me in good stead.

 

I had long discussions with Dr. Tirant on this subject and he is a great believer in meditation also.

 

I really feel Dr. Tirant is on to something here and I hope he can help thousands of other people as well, as he has helped me.

 

M.O’L Writes:

 

Firstly I must say thanks for the opportunity to take part in this trial. It has been a great opportunity to use a treatment which has worked so well for me. From the perspective of one who has lived with ups and downs of being a Psoriasis sufferer, my thanks are truly heartfelt for the success I have experienced.

 

I started the treatment in mid July ’95 going to Dr. Tirants clinic for fortnightly appointments over a period of 6 weeks, after which I stopped whilst awaiting the birth of my child in early September.

 

Over that time I had a gradual improvement in my condition. Which had completely cleared by the time of the birth on September 1st.

 

The Psoriasis was generally spread, with patches on my legs, arms, back and scalp – the most severe being lower back and scalp. It had been very active and flaking, at times cracking and bleeding with discomfort.

 

I found that the treatment works best when correctly adhered to. Initially I had confused application methods, and had a much quicker improvement result when used directly according to directions.

 

I come from a family which tends to Psoriasis. I am 39, having suffered with the condition since my early teenage years. It has been progressively spreading since it first appeared and I feel I have tried every product available. All of them either not working at all, or else working initially for a short time and then not again once the initial remission had passed.

 

It has been 2½ months since stopping use of the cream and gel, and I am having some slight return of the condition. I am again using the treatment and it is responding by again clearing the skin.

 

I avoid all fatty foods, being dairy food and margarines and all animal fats and I try to eat as much leafy greens as possible (though I’m not so consistently successful there as I could be!)

 

The biggest test for me will be if the cream continues to work on the condition when it again erupts. So far I have had success on my arms and legs, and the return of the patches has been very minor indeed.

 

For me, the most challenging part of the treatment, is the avoidance of those things which may aggravate the condition i.e. dietary adherence to avoiding the wrong foods.

 

A shorter and easier haircut has facilitated the twice daily shampoo and body wash requirements. I have found the cream to be easy to use with no side effect such as staining of clothing or worries of the chemicals in the cream.

 

The gel is also an easy substitute for soap or shampoo with no difficulty or discomfort in application.

 

I found Dr. Tirant to be very understanding of the condition and his manner always very pleasant and welcoming.

 

I am very pleased with the condition of my skin and I genuinely hope that other Psoriasis sufferers will take up Dr. Tirant’s treatments, thereby receiving the same beneficial results which I have experienced.

 

R.C. Writes:

 

You may recall from my letter of 21st September that I have had a previous bad attack of Psoriasis and that long and complicated procedures were required to get rid of it.

 

For my recent attack of mostly “all over” Psoriasis (excepting face and hands) I had the benefit of being a member of the Association and its newsletters, especially the June 1996 issue, and its introduction therein of Dr. Tirant who I first consulted in July and at which photographs of the affected areas were taken. He also supplied me with his cleansing gel and cream and the procedures I was to follow.

 

Particularly as I am a widower, aged 84, and a cripple with hip trouble and require assistance to apply the gel, shower and cream, weeks were lost trying to get somebody to help me.

 

Eventually a friend came to my assistance for a limited time. Late in August I was admitted to hospital because of a chest infection and the nurses there were most helpful twice per day. Other helpers were my son and a longtime friend who came to my home twice daily for two or three weeks during the final stages.

 

I had several consultations with Dr. Tirant, i.e. 12 July, 14 August, 4 September and finally 20 September at which date he informed me that my Psoriasis was cleared up and that no further treatment was required. Final photographs of the previously affected area were taken.

 

It was a pleasure to be a patient of Dr. Tirant.

 

D.M. Writes:

 

My Psoriasis first appeared 20 years ago, at age 21. Even before that I had dandruff, but now I found myself itching my scalp constantly, with big thick scales coming off and covering my lap or the table. Soon it appeared around the scalp margins, particularly on the forehead, as scaling and redness. In the next year or so it also developed under the pubic hair, on the penis and under the arms. These were the main areas for the next 15 or so years.

 

In the last five years I also developed big areas of Psoriasis on my back, abdomen, throat, one knee and lower legs. The area on the back was the biggest, about 15 X 13cm.

 

All these patches were very red, itchy and scaly, with me being unable to resist scratching them and peeling scales off just about all the time.

 

I have been through much emotional turmoil (and healing, I suppose) coming to terms with it. And I have used many treatments, medical and naturopathic. Nothing was much help. Even steroids were of limited benefit, and I didn’t like what I knew of their potential damaging effect on the structure of the skin.

 

The results with Dr. Michael Tirant’s treatment, starting three and a half months ago, were immediate. Within a couple of weeks of applying the cleansing agent and the cream the scaling on most areas had stopped completely. Within a few more weeks even the redness on the forehead and edges of the scalp completely disappeared. The other areas on the body were considerably improved, though still quite visible. Now after three months, the situation is very pleasing. The big patches on my torso and legs are still visible, but much, much less red with no scaling whatever. The itching is about 90% gone. The pubic and penis lesions are almost invisible. The only area with scales still forming is under the hair. I have extremely thick hair and it is difficult to get the cream under it. I wash my scalp with the cleanser, and that does not appear to be enough. I am planning to virtually shave my head so that I can treat the scalp properly.

 

Obviously I am very happy with the treatment. It is the only thing which has ever really worked for me. I don’t know if the skin discoloration will disappear where the patches on the legs and torso were. It really doesn’t seem very important, the improvement has been so great.

 

The only drawback of any kind has been that in the beginning, when I was applying liberal amounts to the very scaly areas, the cream would stain my shirt, undies and pillow. It did not completely wash out. A very minor problem in the light of the good results I was getting.

 

I have been very fortunate to be on a free trial, so the cost has not been a problem for me. Thank you to the Psoriasis Association and Dr. Tirant.

 

Dr Tirant writes:

 

Psoriasis which affects about 2% of the population is the cause of great distress and discomfort to many resulting in hospitalization for some. As there is no present cure for psoriasis, many treatments have been used to try and control it. However, long term total resolution of active psoriasis has been difficult to achieve for some patients. In my opinion to achieve long term remission with psoriasis, a holistic approach must be taken!

 

Psoriasis is a hereditary condition which may lie dormant for many years without symptoms and is triggered by environmental factors. The common triggers that have been identified include injury to the skin (koebner phenomenon), infection (streptococcal), and the taking or cessation of certain drug. However, from my experience there are other factors that exacerbate this condition. With detailed history and close monitoring on my patients I’ve found that the following play a vital role in aggravating the condition.

 

1. Inadequate supply of green vegetables. (spinach, beans, peas, broccoli, asparagus, celery).

 

2. Large intake of acidic foods (tomatoes, chilli, peppers, berries, citrus, pineapple, soft drinks (carbonated), alcohol).

 

3. Inadequate water consumption.

 

4. Stress

 

I can remember my mother telling me to eat all of my green vegetables when I was growing up. “They are great for your skin”, she used to insist. In the case of psoriasis sufferers never a truer word was said. The exact mechanism of their action is not known but I’m taking a keen interest to try to elucidate their role.

 

It is a known factor that acidity and psoriasis or any skin condition don’t go together. Ingestion of acidic products create and acidic environment which inflame the condition. Alcoholic drinks also aggravate the condition. In my opinion it is the acidity of alcoholic drinks that exacerbate psoriasis. Water being the cleanser and moisturizer in the body is required in copious amounts. A large amount of water is lost through normal bodily functions such as respiration, perspiration, urination etc. and therefore needs to be replenished. It is interesting to note that drinking coffee, soft drinks and alcohol does not provide the body with much water. In fact they dehydrate the body. Stress/worry plays havoc with psoriasis. These negative, suppressive energies have to be balanced with daily realization. This doesn’t have to be done for long periods. It can be done several times over a day when you are able to manage the time.

 

Suggestion:

 

1. Sit yourself comfortably – uncross arms/legs.

 

2. Close your eyes.

 

3. Take five deep breaths.

 

4. Think of one positive/happy thing in your life that makes you smile inside.

 

5. Let that happy/positive feeling go right through your body.

 

6. Concentrate on this happy feeling and visualize yourself having some fun.

 

7. Concentrate on that for 5 minutes at least twice a daily.

 

It’s magic for stress and for your psoriasis.

 

This, combined with my treatment regime of adherence to the four triggering factors mentioned earlier, and the products should see positive results.

 

Success – the products which are natural have been used to treat all forms of psoriasis for a number of years. The number of patients treated in that time runs well into a thousand plus. The response has been outstanding with the majority of patients going into remission after six to eight weeks of treatment. The products are very easy and quick to apply and non-smelly/non-staining and patients normally see improvements after seven-ten days of treatment.

 

I believe that the prognosis for psoriasis sufferers is very good because at last there is a treatment regime that if adhered to can provide long term relief.

 

I should add that I have found this treatment very successful for sufferers of eczema as well.

 

The contents of the testimonials have not been altered in any way and is entirely the work of the participants of the trial.

 

 

Psoriasis Association Follow-up on Trial Patients

A follow up on Tirant trial participants – one year later – taken from The Psori Newsletter Volume 43, October, 1996.

 

Regular readers of our newsletter will be aware that five of our members were given the opportunity to participate in a trial of Dr. Michael Tirant’s treatment for Psoriasis. Over time many inquiries have been made about his treatment, so we felt we should return to our participants, twelve months down the track, and see how they are going.

 

We have received responses from four of our participants only and they are presented for you in an edited form, as some information was not relevant to the trial. As always, we do not provide the participants names to protect their privacy.

 

M.N. Writes:

 

In reply to your letter regarding Dr. Tirant’s treatment, where my Psoriasis cleared up after using the ointment, it has not returned, however, there is one area that is still active, but in fairness I must say that I have discontinued using the ointment on this particular spot, because I did not think it was progressing.

 

I have reverted to Daivonex, which is keeping it in check, but I would recommend to others, Dr. Tirant’s treatment as it was good for me, initially, and I may resume using it at a future time.

 

M.O’L Writes:

 

Thankyou for your letter enquiring as to the condition of my Psoriasis since finishing Dr. Tirants trial.

 

I agree with you that it is worthwhile to note the long term results from the trial, as we Psoriasis people know that it is an ongoing condition, with the skin itself fluctuating with treatments.

 

As with the other trial participants, I achieved extremely successful clearing of the condition within a fairly short period of time.

 

I have on all occasions, after childbirth had a strong recurrence of the Psoriasis. After around two months I developed Pustular Psoriasis on both legs from the knees down. Initially I was reticent to take medication as I was breast feeding and concerned for the effects. I returned to Dr. Tirant after another two months. I had been using his treatment before this, but it did not seem to be impacting on the skin, and acne condition was continuing to worsen. However, I returned and persisted with the treatment and although is was assisting in the prevention of scale build up, the acne became so painful that it was difficult to even apply the cream to the skin. It was a very persistent acne like condition that lasted for six months and has left deep scaring. Eventually I went to my G.P. and required anti-biotics, and changed over to Linotar products. With this, and the return of my body to its regular menstrual cycle the condition began to dissipate.

 

I have not experienced Psoriasis like that before, although during that time the rest of my body remained clear of scaling Psoriasis apart form one small patch on my back.

 

I have been using meditation and following the diet, however, I had included cider vinegar and honey drinks for arthritis which I get to a small degree in some of my joints. I have since stopped the cider vinegar – this may have aggravated the Pustular Psoriasis, I’m not sure.

 

I am just noticing now, 11 months after finishing the treatment that a few small areas of the scaling Psoriasis are beginning to reappear. With prompt and regular treatment from Dr. Tirant’s creams the skin has returned to its normal condition within a relatively short period of time.

 

Generally, I would say that apart from the Pustular condition, my skin has been in a very long period of remission and is responding again to Dr. Tirant’s treatment.

 

W.C. Writes:

 

I can give you a brief outline on my Psoriasis since the all over attack I had at the time of Dr. Tirant’s trial. I am pleased to report that, since then, I have had a complete recovery and no recurrence at all.

 

l.S. Writes:

 

I am writing to let you know of my progress with Dr. Tirants treatment.

 

Firstly, my skin is quite clear. I have had a few patches re occur on the main part of my body and these have cleared once again with the ointment. But I noticed under the arm and around the groin are not responding to the treatment.

I will keep you posted.

 

*Our thanks to the above members for allowing us to follow their progress over the last twelve months.

 

The follow up has provided some valuable information from the patients but the one thing that it lacks is whether all the patients are still addressing the triggers – since there is no mention of that, it is assumed that they are not all addressing those vital factors.

 

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Dr Michael’s Topical Product Family In Psoriasis, Results Of The Hungarian, Romanian, Russian And Austrian Clinical Trials

April 4, 2012

 

INTRODUCTION

 

Psoriasis is:

 

Inflammatory & proliferative disease

Results in chronic, sharply demarcated plaques with silvery scales

Can be very severe – can lead to hospitalization

Can be itchy

Non-contagious

A chronic, recurring skin disease affecting 2-4% of the population

Genetic predisposition and secondary triggers play a role in its etiology

Can occur in any age group or gender

Frequently affected areas of the body include scalp, extensor surfaces of the extremities, skin folds and nails

Cannot be cured – but can go into remission

Since psoriasis cannot be cured, it is important to find treatments that are safe and can be used long term. At present topical corticosteroids at the mainstay of therapy for stable chronic plaque psoriasis. Over the past few years, there have been growing concerns about the side effects of steroid therapy. Patients, the world over, are looking for an alternative therapy which is effective and safe. Herbal remedies are the most common treatment options available, however most of these topicals have not undergone the rigorous testing required by the scientific bodies. Over a twenty year period, Dr.Michaels product family has shown to be both effective and safe, however lacked the independent scientific clinical testing.

 

AIMS OF THE STUDIES

 

The studies of the Dr Michaels topical product family were designed to determine the efficacy of the preparations in the treatment of cases of psoriasis with differing severity and establish whether these natural oil contents (the composition and ratio of the natural oils) were able to decrease the psoriatic parakeratosis, inflammation and infiltration.

 

OBJECTIVE

 

To determine the efficacy, adverse effects andtolerabilityof Dr Michaels topical product family.

 

CHARACTERISTICS OF THE TESTED PRODUCTS

 

Dr Michaels Scalp and Body Cleansing Gel

Loose, white-opaque, easily applicable topical preparation

 

Effect: Decreases parakeratosis

 

Application: Applied before the use of the ointment.

 

Scalp: Wet scalp and apply a small amount of cleansing gel. Massage thoroughly and leave for 2-3 minutes. Wash off with lukewarm water.

(Can be applied to forehead but avoid cheek area).

 

Body: Wet body. Apply small amount of cleansing gel to the psoriatic plaques. Leave for 2-3 minutes then rinse off with lukewarm water.

Active Ingredients: Organic acids, fruit acid complex.

Package: 200ml plastic bottles.

Dr Michaels Scalp and BodyOintment.

Yellowish-white ointment with characteristic scent.

 

Effect: Decreases inflammation and infiltration.

 

Application: Applied to the psoriatic plaques of the scalp and body after using and washing off the cleansing gel. Only apply to severely infiltrated plaques on the scalp.

 

Ingredients: Vegetable oils (wheatgerm oil, sweet almond oil)

 

Essential oils (lavender oil, rosemary oil, citronella oil)

 

Packaging: 50g and 200g plastic vials

 

Dr Michaels Skin Conditioner

Effect: Prevent the loss of flexibility and elasticity in the skin.

 

Application : Applied to the psoriatic plaques two minutes after using the ointment (without washing it off)

 

Application to the scalp without ointment : The conditioner is applied to the scalp, left on over night and then washed off in the morning using the cleansing gel.

 

Ingredients: A mixture of vegetable and essential oils (olive oil, sesame seed oil, emu oil, lavender oil, eucalyptus oil, natural vitamin E).

 

Packaging: 50ml and 200ml plastic bottles.

 

IT IS RECOMMENDED TO APPLY THE THREE-COMPONENT PRODUCT FAMILY TWICE DAILY, MORNING AND NIGHT.

THE TRIALS

 

The Hungarian and Romanian open trials involved 57 patients (30 males, 27 females), suffering with mild to moderately severe plaque type psoriasis, between the ages of 18 to 80 years old. The mean age was 45.2 years with a mean duration of psoriasis of 15.3 years.

 

Five patients dropped out due to non-compliance and one due to retraction of informed consent.

 

The evaluation was based on Psoriasis Area Severity Index (PASI) score at each of the 8 medical evaluations. Evaluated features included erythema, infiltration, parakeratosis and size of affected lesions.

 

Eight weekly evaluations were done.

 

The evaluation of improvement was based on the following:

 

Worsened PASI score higher than baseline

 

No improvement PASI decreased 0-25%

 

Moderate improvement PASI decreased 26-50%

 

Good improvement PASI decreased 51-75%

 

Outstanding improvement PASI decreased 76-100%

 

The product family proved to be ineffective in 5 of the 57 patients (9%).

 

11 patients (19%) had good improvement with 51-75% of skin lesions disappeared.

 

30 patients (53%) showed outstanding improvement with the regression of 76-100% of the lesions.

 

23% of the patients developed folliculitis for a short period as s side effect. The folliculitis was noted on a few plaques of the lower extremities and was insignificant in terms if severity. 5% of the patients developed pruritis, which regressed without discontinuing the application.

 

No contact sensitization was noted, which is probably due to the thorough screening applied during patient selection.

 

The cosmetic effect was evaluated as indifferent by 49% of the patients, as good by 35% of the patients and as excellent by 16% of the patients.

 

The evaluation of the treatment differed from that of the physician. The physician considered the improvement outstanding in 53% of the cases, while the patients considered it outstanding in 33% of the cases. The differences can be explained by the fact that the physician’s evaluation was based on a pre-determined scale and calculation of percentage changes, while the patients evaluation was entirely subjective. Many patients would have given outstanding only for complete clearing of the lesions. 95% of the patients stated that they would continue to use the product family including those who had only moderate improvement. They argued that as the product family was a cosmetic not a medication, they were not considered about safety and bad side effects.

 

Conclusion

 

Based on the results of these studies, Dr. Michaels new complementary treatment can be successfully applied in mild to moderately severe psoriasis.

 

 

In the Russian clinical examination there were 30 patients between the ages of 9 to 60 years with psoriasis of different severity. There were 3 girls, 12 boys while the adults consisted of 5 women and 10 men. The severity of the clinical symptoms were evaluated using PASI scores with

 

Mild psoriasis PASI less or equal to 20 (12 patients)

 

Moderately severe PASI bigger than 21 and less or equal to 50 (9 patients)

 

Severe PASI bigger than 51 (9 patients)

 

Four evaluations were done at weekly intervals. 10 patients (84%) in the mild psoriasis group went into clinical remission and 2 patients had no improvement. 4 patients (44%) in the moderately severe group went into remission, 2 had significant improvement, one had improvement and 2 had no effect. In the severe group 2 patients (22%) went into remission, 4 patients had significant improvement, 2 had improvement while one had no effect.

 

In the 30 patients treated, 22 patients (73%) had significant improvement or better. Dr. Michaels product family is highly effective and in terms of efficacy, it is comparable to the generally used therapeutic regimen, which is based on the application of corticosteroids with fluorid content. Dr. Michaels preparations do not have severe side effects and are user-friendly. They do not have an unpleasant smell and do not stain the underwear. They can be successfully applied in the case of outpatients as well. Dr. Michaels preparations have been used successfully on patients with psoriasis exceeding 30% of total body surface area (TBSA), however other parallel applications available CANNOT exceed 30% of TBSA of the patient.

 

Conclusion

 

Based on the clinical results Dr. Michaels product family can be used successfully to treat mild to severe forms of plaque and exudative types of psoriasis.

 

 

The Austrian trial was a “Randomized Controlled double-blind study” involving 34 patients (15 females, 19 males). Evaluation of improvement was based on PASI scores. 14 patients in the verum group (those treated with Dr. Michaels product family) and 10 patients in the placebo group completed the treatment course, 10 patients did not complete the eight week of trial. Before therapy, the mean PASI score of the verum group was 6,8 +/- 2,4 SD, while the placebo group was 5,5 +/- 2 SD. After the 8 week treatment course, the mean PASI score in the verum group was 1,2 +/- 1,01 SD which is equivalent to a PASI score reduction of 89% +/- 14,9 SD. The respective values for the placebo group were 4,1 +/- 1,7 SD and 22% +/- 28,7 SD.

 

The decrease in PASI scores in the verum is very significant after 8 weeks

 

(P < 0,0001).

 

Three patients in the verum group and 3 patients in the placebo group reported mild and transient side effects (irritative dermatitis, folliculitis), which did not require any special therapy or caused the patients to discontinue treatment. The majority of the patients who dropped out came from the placebo group.

 

Conclusion

 

The investigation showed that Dr. Michaels product family is effective and safe for the treatment of stable chronic plaque psoriasis.

 

The results from the clinical investigation were so outstanding that the investigators believed that Dr. Michaels product family must contain corticosteroids or calcipotriol. To qualify these issues the Austrian Health Ministry ordered chemical tests be performed immediately. Tests were carried out using HPLC, DAD, and UV methods for calcipotriol and 104 variations of corticosteroids. All the results showed that Dr. Michaels product family contains NO corticosteroids or calcipotriol.

 

Based on 4 independent clinical investigations involving 121 patients, Dr. Michaels product family has proven to be effective in the treatment of mild to severe plaque and exudative types of psoriasis.

 

This document was compiled from the Clinical Reports produced from each of the Investigating Institutions by

 

Jutka Sibik-Kov ács

 

RICA Pharma s.r.o

 

Tel : +420 602 290 318

 

e-mail: skj@ricapharma.cz

 

no comments | posted in Clinical Trials,News

 

Prospective, Randomised Placebo-Controlled Double-Blind Study – Chronic Plaque Psoriasis

April 4, 2012

 

PROSPECTIVE, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND STUDY ON THE EFFICACY AND SAFETY OF A SERIES OF HERBAL SKIN-CARE PRODUCTS FOR STABLE CHRONIC PLAQUE PSORIASIS

 

Harald Maier, Peter Donath, Michael Tirant, Dragana Relic, Shahla Farokhnia, Herbert Hönigsmann, Adrian Tanew

 

Division of Special and Environmental Dermatology, Department of Dermatology, University of Vienna Medical School

 

INTRODUCTION

 

At present, topical cortisone is still the mainstay of therapy for stable chronic plaque psoriasis as long as the affected skin area is not too extensive. However, there is growing concern among patients about possible side effects of steroid therapy. A recent study showed that overall, 42 % patients were unsatisfied with the current management of their skin disease. This is the reason why, like in other medical specialities, patients with psoriasis more and more, turn to complementary treatment options such as magnetic field resonance therapy, traditional Chinese medicine (TCM) and herbal medicine. It is the young, the well-educated, patients with higher income, women and patients with chronic disease who are most open-minded to complementary methods. Actually, a flourishing market for complementary health products has developed. Unfortunately, most providers refuse to have their products tested according to international scientific standards. Advertising is merely based on anecdotal reports and the single opinions of (mostly prominent) persons. At the very best, uncontrolled clinical observations are presented.

 

STUDY OBJECTIVE

 

We assessed the efficacy and safety of an Australian series of herbal skin-care products (Dr. Michaels ® skin-care products for psoriasis) for the management of stable chronic plaque psoriasis. The producer claims that the skin disease improves significantly within a 6 to 8 weeks treatment course.

 

Methods: Inclusion criteria were: male or female patients with light to medium chronic plaque psoriasis. No other antipsoriatic treatment was allowed. Any antipsoriatic therapy had to be discontinued at least 2 weeks previously. We chose a prospective, randomized, double-blind design. As control we used a series of three common fatty skin-care products which contained no active ingredient. The guidelines for the use were identical for both product series. All skin lesions except the scalp were treated. The cleansing gel was distributed generously on the lesions and washed off after three to five minutes with warm water. Afterwards the lesion was covered with the ointment. After the ointment had dried up the patients applied a thin layer of skin conditioner. The procedure was performed twice daily over a period of 8 weeks. Before treatment, after 2, 4, 6 and 8 weeks a blind observer assessed the Psoriasis Area Severity Index (PASI). The values of scalp involvement were not included. Standardized photos of typical lesions were taken before and after 2, 4, 6 and 8 weeks treatment. For statistical analysis we used Mann-Whitney-U Test made with SPSS for Windows.

 

Results: We assigned 34 (15 f /19 m) patients to our study population. 14 patients of the group which was treated with the herbal products and 10 patients of the control group completed the treatment course. Before therapy the mean PASI score of the group with the herbal products was 6.8±2.4 SD, and 5.5±2 SD in the control group, respectively. After the 8 weeks treatment course the mean PASI score reduction in the herbal group was 1.02±1.01 SD, which is equivalent to a PASI score reduction of 89%±14.9 SD. The respective values in the control group were 4.1±1.7 SD and 22%±28.7 SD. Three patients in the herbal and three patients in the control group reported mild and transient side effects (irritative dermatitis, folliculitis).

 

DISCUSSION: This study shows that the herbal skin-care products tested improve mild to moderate stable chronic plaque psoriasis significantly. One strength of this study is the clear study design which is regarded as the gold standard of clinical tests. As is well known, the PASI is a standardized internationally accepted evaluation score which in the hands of an experienced clinician is a reliable assessment tool.

 

It was so obvious in the study course that the verum products were superior to the placebo preparations. Except for coal tar which is present in only the cleansing gel, none of the listed herbal ingredients is a known antipsoriatic remedy.

 

Therefore, an analysis for undeclared drugs (cortisone, calcipotriol, macrolides) was undertaken although the producer (who is one of the authors, M.T.) gave a statement of innocuousness and provided the complete list of constituents and the respective material safety data sheets. Two samples of different batches of each product were analysed. None of the products contained any of the compounds mentioned above.

 

CONCLUSIONS: The products tested already fulfil a lot of aspects addressed by the European Parliament in the proposal for a directive on traditional herbal medicinal products. Our investigation demonstrates that complementary methods may play a role in dermatologic therapy as far as they undergo standardised clinical trials and fulfil the basic requirements such as product safety and quality assurance. Dr Michaels skin-care products can be used successfully in the treatment of stable chronic plaque psoriasis.

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