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Dermatological Clinic at University of "Tor Vergata" – Roma
Catia De Felice, Sergio Chimenti

CLINICAL EFFICACY AND SAFETY OF A COMBINED FORMULATION OF ZINC PYRITHIONE 0.25% AND BETAMETHASONE DIPROPIONATE MICRONIZED 0.05% IN THE TREATMENT OF MILD TO MODERATE PLAQUE PSORIASIS.

Abstract, background: Psoriasis is a common chronic inflammatory skin disease characterized by erythematous and scaling plaques. The ongoing understanding of its pathogenesis has led to new therapeutic options and new areas of research which aimed at reducing keratinocyte proliferation and suppressing T-cell activation.

Objectives: To evaluate the efficacy and safety of topical use of a combined formulation of zinc pyrithione 0.25% and betamethasone dipropionate micronized 0.05% in a base of isopropyl myristate used in mild to moderate plaque psoriasis.

Methods: A total of 32 patients were enrolled into a prospective open clinical trial. Patients were first treated with the combined formulation of zinc pyrithione and betamethasone dipropionate, which was topically administered twice daily for two weeks. After the 2nd week of therapy, zinc pyrithione emulsion alone was applied twice daily for two weeks and twice daily two to three times a week for the following two weeks. Efficacy and safety were assessed.

Results: Our results showed that the combination of zinc pyrithione 0.25% and betamethasone dipropionate micronized 0.05% in a base of isopropyl myristate rapidly reduced erythema, thickness and scaling. Clinical improvement and Psoriasis Area and Severity Index (PASI) reduction occurred in less than two weeks of therapy. The maintenance product, zinc pyrithione alone, was able to complete the clinical remission, reduce the frequency of recurrences and avoid a long term use of topical corticosteroids.

Adverse reactions, such as lesional/perilesional dryness and mild itching, occurred in 12.5% of all patients (4/32), but improved throughout therapy by applying an emollient once daily when needed.

Conclusions: Our findings suggest that a combined formulation of zinc pyrithione 0.25% and betamethasone dipropionate micronized 0.05% in a base of isopropyl myristate is an effective and well tolerated topical treatment worthy of consideration for patients with mild to moderate plaque psoriasis.

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Department of Gynecologic Obstetric and Reproduction Sciences, Second University of Naples, Naples (Italy)
Giampaolo Mainini, Cono Scaffa, Pasquale De Franciscis, Mario Rotondi, Francesco Lup, Angelo Ragucci

A new approach to the treatment of vulvar lichenification in post-menopausal women with zinc pyrithione 0.25%

Abstract: The vulva is more irritable than extra-genital skin because more absorptive of irritants. Vulvar skin reacting against irritant agents can show the so called “lichenification”, that is elasticity loss, dermis thickness, itching, erythema. During menopausal age we can have phenomena due both to normal tissue aging and to estrogens levels collapse with dystrophy/atrophy of target organs that are, more over, dermis and epidermis.

Objective: To assess efficacy, endurance and compliance of topical cream containing zinc pyrithione (ZPT), skin eutrophing with bacteriostatic and micostatic activity, anti-itching and anti-desquamation, in the treatment of vulvar lichenification in post-menopausal women.

Methods: 40 women in post-menopausal age with symptoms and signs of vulvar lichenification in topical therapy using a cream with zinc pyrithione 0.25% in a vehicle containing isopropyl myristate applied to vulvar area twice daily for 2 weeks, with a maintenance treatment plan of one application per day three days a week along 4 weeks (total treatment period: 6 weeks).

Results: Significant improvement of symptomatology (after the first 2 weeks of therapy yet) in the most cases, side effects minimal and good compliance regarding to treatment acceptability and smoothness.

Conclusion: Although further studies are still needed, zinc pyrithione 0.25% cream, as a new approach to the treatment of vulvar lichenification in post-menopausal women, appears to be efficient in efficacy, endurance and compliance.

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DERMATOLOGY AND VENEROLOGY
PHOTOTHERAPY CENTER

CENTER for the RESEARCH and TREATMENT of PSORIASIS, VITILIGO and ICTHYOSIS
AISP(Interdisciplinary association for psoriasis research)
ISPLAD CENTER (PLASTIC SURGERY)
COSMETIC SURGERY CENTER

Director: Dr. Antonia G. Galluccio

Since February 2004, The Center of Dermatology and Phototherapy at “S.Cuore di Jesu” hospital in Fatebenefratelli di Benevento has been using a 0.25% zinc pyrithione based emulsion together with betamethasone dipropionate 0.05% concentration-(43 mg per 100ml of Z DERM Emulsiom ) and a 0.25% zinc pyrithione based cream together with a 0.05 % concentration of betamethasone dipropionate to treat mild to moderate cases of psoriasis vulgaris.

62 patients have received treatment using the emulsion while 25 patients have been treated with the cream.

The 62 patients treated with the emulsion (32 men and 30 women ) displayed mild to moderate cases of psoriasis vulgaris with PASI index levels ranging from 5 to 11. Instead the 25 patients treated with the cream ( 15 men and 10 women) had more severe cases of psoriasis vulgaris at levels ranging from 10 to 13 on the PASI index.

In the milder cases, significant clinical improvement was noted after 15 days of treatment which included one application every evening. Tha scaly aspect had disappeared and there was a noticeable reduction of the permeation. In 35 of the 62 patients (47%) there was a complete remission of the lesions, in particular in lesion located on the scalp, while 27 of 62 patients (53%) showed a partial remission with rash and itching disappearing completely.A slight permeation persisted in a few patients.

None of the patients had to suspend the treatment.

After 15 day of application once daily, the 25 patients treated with the 0.25% zinc pyrithione based cream plus 0.05% betamethasone dipropionate concentration ( 15 men and 10 women) showed noticeable improvement in clinical manifestations of psoriasis and their PASI index levels dropped below 7.

After 4 weeks of treatment and 8 weeks of maintenance ( three applications per week, one time a day) these same patients, both those treated with the emulsion plus betamethasone dipropionate and 80 % of those treated with the galenical cream, did not display any recurrences nor did they suffer any adverse reactions.

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Clinica Geriatrica Sant’Orsola, Bologna
By: Prof. Semeraro

Testing from spring 2002_October 25th 2002.

I used Z•Derm®, with excellent results on some of my patients.
Particularly successful was the experience with Mrs C.A. 1939.

The patient presented a typical symptomatology of severe level psoriasis, for the extension of the condition to the trunk and lower limbs. After a few weeks, a clear regression of the lesions, especially to the trunk and with a virtual resolution in the following months.

Prof. Sergio Semeraro, geriatrics in Bologna.

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Testimonials

…a magical occurrence happened to me a few months ago. In a casual conversation with you I mentioned that I had psoriasis on my right leg for the past four years. You indicated that you knew a cure. Even thought I had tried many so-called “cures” over the past few years, I was receptive to trying your product.

I used Z•Derm® compound according to your instructions for about 10 days, with my physician consent.
As if a miracle, the psoriasis vanished. It was like magic!

I now continue to use Z•Derm®‚ OTC and the ugly condition seems to have permanently disappeared. Because of my enthusiasm for the product, my son-in-law has also begun treatment and is similarly pleased with the results of Z•Derm®‚ compound + Z•Derm®‚ OTC. I am grateful to you for your advice.

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Robert F. Sutner



…The only product, among so many prescribed, to have achieved a great rate of effectiveness.In my case (guttate psoriasis spread all over the body): vanished after 1st treatment (june). 2nd treatment just ended (18.02.02) with a reduction of the pathology of about 80% . Beginning maintenance 19.02.02 at the end of which I believe to achieve a further reduction of the pathology.

R.L. 1951, Pesaro



"The greatest Christmas present ever!! Please find enclosed the pictures after using the presecription Z•Derm® Spray with Corticosteroid… I have only been using the spray for six days. As you can see, my face, chest, back and arms are 80 percent clear. It is so wonderful to have clear skin again!"

Than you again,
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Alan Bentz, M.D.



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Sincerely,
Mary Rottminge



"One of the newest and hottest treatments for psoriasis is zinc pyrithione… This product (Z•Derm®) is available as a pump spray, bar soap, and scalp solution."

Alan S. Boyd, M.D.
The Skin Sourcebook
Copyright © 1998 by NTC/ Comtemporary Publishing Groups, Inc




"Relationships are important to me, and I believe that several women who cared for me were put off by my skin condition… I know that I am not alone in this. And that we psoriasis sufferers stay back, isolate ourselves, almost as lepers! Indeed there is a 'heartache' which is psoriasis, but finally there is relief. Please carry on your good works!"

G.G. Spater



"I just started using Z•Derm® Spray a month ago and have already seen amazing results. I have had psoriasis for 20 years now and your product is the only thing that has helped at all. Now that my skin has cleared up I am looking forward to going to the beach in my new bathing suit! Thank you very much for making this wonderful product."

Erin Brant



"I am writing this letter to tell about my success using your product, Z•Derm® Spray… My skin condition returned to normal after a month-and-a-half of use… This method is low cost, low maintenance and is the most efficient product that I have used…"

A customer for life,
Wayne Duhamill





"Recently my doctor prescribed Z•Derm® with Corticosteroid for my psoriasis. The results I have achieved are spectacular. Not only is my skin clear but I am able to keep clear skin using the over-the-counter (Z•Derm®) spray."

Sincerely,
Jamie Vance



"I am excited to say that Z•Derm® has changed my life."

Than you so much,
Mary Fink



"I've been suffering for 20-plus years from psoriasis. I have probably gone to 50 dermatologists and have taken everything, including cortizone shots right in the bone… I've bought every salve… every prescription and every cortizone treatment available in pharmacies."It's been nine days since I began using Z•Derm® and I can't describe it… it's a 70- to 80-percent marked improvement. My wife and I went out yesterday and I bought six short sleeve shirts… basically, it's the first time I have bought any in at least 10-15 years"



"I couldn't be happier. I used to go the beach, until I realized everyone was looking-at me. Then I would only go early in the morning. I used to take a shower before going and scrubbed until I bled.Now it's a pleasure to take a shower. Now I can go to the beach any time I want.There are a lot of pluses to Z•Derm® I feel better emotionally and physically."

Mark Wilcox



"I am writing to you in joy. Half of my life I have suffered from psoriasis. I have struggled financially and emotionally fighting this skin disorder for as long as I can remember. When I discovered this Z•Derm® product over the Internet I had little to no hope that it would help any. Needless to say, I tried the product out of desperation and could not have been more surprised when my skin began to clear three weeks later. I now live a normal life, not having to cover my body out of embarrassment. It's great and I owe it all to your company."

Farnez Kojic



"I just thought I'd tell you how happy I am with you Z•Derm® Soap. For five years now I've been trying everything to stop my face from itching, from standard Western allergy medications to Chinese herbal treatments and acupuncture, to no avail. Then I heard about Z•Derm® Soap and I thought I'd give it a try. It has worked wonders. I can feel my skin improving every day, and the itching has subsided considerably. I plan to recommend it to friends and relatives with skin problems."

Yours sincerely,
Myunghee Myers



"Thank you! I just got my second bottle of Z•Derm® (Spray/Drops). For years I've had psoriasis. I've used prescription medicines with little results. Your spray, which is easier to use, showed a big change I have not seen for years."

Mr. John Kruchten



"I have been using Z•Derm® on my hands for approximately three weeks. I can't begin to tell you what a difference this product has made… not only have my hands improved, but my lifestyle as well. I am an active person with a career in sales…"The simple things in life often have been impossible due to my condition. When my hands are at their worst my favorite activities and day-to-day necessities are often interrupted… I highly recommend this product. It has truly made a remarkable difference in my life… Not only have I been able to maintain my lifestyle uninterrupted by severe skin problems, I have also spent the last few weeks of my summer without waking up in the middle of the night scratching non-stop for nearly an hour… "



"Last year I was given a gift certificate for a manicure. Needless to say it has sat in the bottom of my desk drawer… until now. I'm looking forward to receiving a little pampering. These hands deserve it!"

With sincere thanks,
Jeanne M. Muse



"I have clear skin for the first time in eight years."

Donald Gilbert



"This is an incredible product. It really works great."

Jean Sipes



"This product is amazing. It cleared my psoriasis in ten days. Thank you."

Paul Kriston



"Your (Z•Derm®) spray has provided relief where other products have failed totally."

Thank you,
Victor E. Schwartz


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