Abschlussbericht über die Pilotstudie zur Überprüfung der Wirkung von Activated Piroctone Olamine (Etikett 100ml) bei der Behandlung von Psoriasis und seborrhoischer Dermatitis bei Patienten im Alter von 15 bis 60 Jahren
Final report on the pilot trial to verify the effects of Activated Piroctone Olamine (label 100ml) in the management of psoriasis and seborrhoeic dermatitis in patients aged 15 to 60 years
Actived Piroctone Olamine has a proven antiseptic, antimicrobial, antifungal and keratolytic effect. The effect is selective, only acting on the morbidly altered cells. A randomized, simple controlled trial type - III, with post-registration monitoring and continuous inclusion of male and female patients according to criteria was conducted to verify the efficacy and tolerability of Activated Piroctone Olamine (label 100 ml) applied in the management of psoriasis and seborrheic dermatitis in patients with significant manifestations of the disease in varying areas of the body (scalp, torso, extremities) of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients. A total of 42 patients were included. There were 4 males and 10 females with seborrhoeic dermatitis, and 9 males and 19 females with psoriasis affecting various areas. The effects and satisfaction with the therapy in the group of patients with seborrhoeic dermatitis was evaluated as excellent in about 71% and very good in about 29%. From the patient's point of view, excellent satisfaction was reported by 57% and satisfaction by 49% of the patients included. No undesired effects were reported. No patient was excluded from the study, and follow-up examinations were performed within the specified timeframes, with a maximum deviation of 3 days. The effects and satisfaction with the therapy in the group of patients with psoriasis was evaluated as excellent in about 54% and very good in 46%. From the patient's point of view, excellent satisfaction was reported by 64% and satisfaction by 32% of the included patients. Only one patient, and in one case the investigator, rated the treatment as insufficient or unsatisfactory for the designated area. No undesired effects were reported. No patient was excluded from the study.
Actived Piroctone Olamine hat eine nachgewiesene antiseptische, antimikrobielle, antimykotische und keratolytische Wirkung. Die Wirkung ist selektiv und wirkt nur auf die krankhaft veränderten Zellen. Eine randomisierte, einfache kontrollierte Studie vom Typ III mit Nachbeobachtung und kontinuierlichem Einschluss von männlichen und weiblichen Patienten gemäß den Kriterien wurde durchgeführt, um die Wirksamkeit und Verträglichkeit von aktiviertem Pirocton Olamin (Etikett 100 ml) bei der Behandlung von Psoriasis und seborrhoischer Dermatitis bei Patienten mit signifikanten Manifestationen der Krankheit in verschiedenen Körperbereichen (Kopfhaut, Rumpf, Extremitäten) unterschiedlichen Ausmaßes zu überprüfen und Unterschiede in der individuellen Verträglichkeit und der endgültigen Wirkung in einer Gruppe ausgewählter Patienten zu bewerten. Insgesamt wurden 42 Patienten eingeschlossen. Es handelte sich um 4 Männer und 10 Frauen mit seborrhoischer Dermatitis und 9 Männer und 19 Frauen mit Psoriasis, die verschiedene Bereiche betraf. 71% der Patienten mit seborrhoischer Dermatitis bewerteten die Wirkung und die Zufriedenheit mit der Therapie als ausgezeichnet, 29% als sehr gut. Aus der Sicht der Patienten berichteten 57 % über eine ausgezeichnete und 49% über eine sehr gute Zufriedenheit. Unerwünschte Wirkungen wurden nicht berichtet. Kein Patient wurde von der Studie ausgeschlossen, und die Nachuntersuchungen erfolgten innerhalb des vorgegebenen Zeitrahmens, mit einer maximalen Abweichung von 3 Tagen. Die Wirkung und die Zufriedenheit mit der Therapie in der Gruppe der Psoriasis-Patienten wurde bei etwa 54% als ausgezeichnet und bei 46% als sehr gut bewertet. Aus der Sicht der Patienten berichteten 64 % über eine ausgezeichnete und 32% über eine sehr gute Zufriedenheit. Nur ein Patient und in einem Fall der Prüfer bewerteten die Behandlung als unzureichend oder unbefriedigend für das betreffende Gebiet. Unerwünschte Wirkungen wurden nicht gemeldet. Kein Patient wurde von der Studie ausgeschlossen.
The first reports on the possibility of using Piroctone Olamine as an effective treatment for patients with papulosquamous dermatoses, eczema and seborrhoeic dermatitis date back to the 1970s. The observations are presented in scientific papers by dermatologists, pharmacologists and laboratory workers who have verified the original thesis in practice by the practical use of different types of products. In order to verify the effectiveness of the preparations, a number of large clinical multicenter studies have been carried out in different geographical zones – from tropical to temperate to Siberian regions. Piroctone Olamine as an active ingredient is now used by a number of companies in their product range, either as the only active ingredient or, for example, in combination with other active ingredients such as liquid carbonis detergens. The Spanish company (CATALYSIS S.L Madrid) has also started to produce preparations containing Actived Piroctone Olamine intended for targeted use in dermatological practice. The original shampoo product has been gradually supplemented by spray and cream formulations. The active ingredient Actived Piroctone Olamine alone or in combination with other active ingredients makes for products with excellent properties. Actived Piroctone Olamine itself has a proven antiseptic, antimicrobial, antifungal and keratolytic effect. The effect is selective, only acting on the morbidly altered cells. The concentrations of Actived Piroctone Olamine Zinc used in formulations are absolutely safe. The products can also be used on the surface of larger body areas and in virtually all age groups.
(Psoriasis vulgaris) is a non-infectious skin disease mainly affecting the skin, with manifestations of typical erythematous lesions and scaly patches most often located on the elbows, knees, lower and upper limbs, on the trunk, also in inguinal and genital region, very often appearing as inverse psoriasis. It also affects the nails and joints in patients suffering from severe forms. It is currently one of the most common skin diseases and affects up to 3% of the population. The aetiology, despite extensive research, is not fully known, however, it involves a number of factors, such as genetic predisposition, autoimmune mechanisms, environmental factors (stress, infection, trauma, impairment and poor liver function, certain drugs, hormonal effects and others).
Clinical manifestations include erythematous, mostly heavily infiltrated, precisely demarcated papulosquamous deposits, sometimes merging into confluent lesions covering large areas. Severe conditions progress to so-called erythrodermic psoriasis. On the scalp, there are thick deposits of flaking and peeling scales, with itching and pain on the affected areas present on the erythematous surfaces [1, 2].
Mild manifestations of psoriasis are generally treated with topical preparations with different content and concentration of active substances, including topical corticoids. Topical therapy takes advantage of products with different content and concentration of ichtamol, picis lithanthracis (the use of which is prohibited in the EU), lactic acid, salicylic acid, Piroctone Olamine, emollients, mineral water baths (spa treatment). Herbal extracts are also used successfully, most recently including cannabis, etc. Topical preparations come in the form of solutions, lotions, creams, ointments, patches, shampoos, oils and others. In severe conditions, the treatment is left at the discretion of a dermatologist or a rheumatologist. The patient is referred to, for example, to receive irradiation treatment in special cabins (UVA radiation) or PUVA, systemic therapy with corticoids, retinoids, cyclosporine, and, most recently after a thorough reassessment of the condition to a specialist to receive biological treatment [3, 4].
Seborrhoea – seborrhoeic dermatitis
The unpleasant congenital condition is caused by overactive sebaceous glands, affecting both the quality and the quantity of produced sebum. The production of sebum also reacts to hormonal influences, e.g. in women before menstruation, in men due to male hormones – androgens, and is also increased by climatic influences, digestive disorders, focal infections, and some serious general diseases (Parkinson’s disease). Research has also confirmed the fact that the aggravation of the disease is also caused by active multiplication of yeasts (Pityrisporum ovale, Malassezia and others) or bacteria on the skin, or gastric disease caused by a bacillus – Helicobacter pylori. Patients often confuse the symptoms thereof with psoriasis, but the physician will always decide on the correct diagnosis.
Clinical manifestations of the disease, the course, as well as the affected areas and the related skin changes may occur at any age and vary accordingly. In children, seborrhoeic dermatitis is often confused with childhood eczema, and some of the apparent similarities are different in the overall clinical picture of the disease, have a course and thus require a different treatment. A combination of the said diseases can often occur. The diagnosis is determined by assessing the typical, relatively well-defined, slightly erythematous deposits, sometimes covered with greasy or dry flakes, present on the skin, itching significantly. In some people, the excessive formation of whitish dry scales is likened to „snowfall.“ At other times, by excessive formation of greasy scales glued deposits appear up to several centimetres in size, which is referred to as Tinea asbestina. Affected areas include the forehead, cheeks, eyebrows, nasolabial folds, periocular area, and chin. Foci behind and around the ears are no exception. Manifestations in adults vary according to sex. For example, men are often affected on the front of the chest covered with hair, and on the back, sometimes in the genital area. The aesthetically troubling appearance is often stressful for the patients. To determine the diagnosis requires a comprehensive and responsible approach to treatmentafter a thorough examination of the patient, including laboratory blood tests, and taking a skin smear. The most common complication usually is a secondary microbial (Staphylococcus) or yeast (Malassezia) infection. The aesthetically unsatisfactory appearance is often stressful for the patient [5 – 11].
Topically applied preparations include recommended creams or lotions, various shampoos, with the exclusion of thick and heavy ointments, preferably liquid preparations with different content and concentration of ichtamol, lactic acid, salicylic acid, Piroctone Olamine, antifungal agents, antibiotics, mineral water baths. Herbal extracts are also used successfully, the latest containing cannabis [6, 7, 8].
B vitamins, trace elements (zinc), treatment of digestive problems, elimination and targeted treatment of focal infections with antibiotics or antifungal agents are generally recommended in systemic therapy. Lifestyle adjustment is highly advisable on the part of the patients [12, 13, 14].
Piroctone Olamine :
Piroctone olamine (INN; also known as piroctone ethanolamine) is a compound sometimes used in the treatment of fungal infections.(16). Piroctone olamine is the ethanolamine salt of the hydroxamic acid derivative piroctone.It is often used in anti-dandruff shampoo as a replacement for the commonly used compound zinc pyrithione. It is structurally similar to ciclopirox and pyrithione, containing a substituted pyridine (pyridinone) group which inhibits ergosterol synthesis.
Actived Piroctone Olamine as an active ingredient is now used by a number of companies in their product range, either as the only active ingredient or, for example, in combination with other active ingredients such as liquid carbonis detergens.
Actived Piroctone Olamine has a number of positive effects on pathological processes in the skin – high antimicrobial and antifungal effect, selective cytostatic effect on skin cells (at the stage of hyperproliferation, but does not affect healthy cells), it regulates the amount and number of cellular enzymes and determines the anti-inflammatory effect (if it is employed in a targeted manner in form of topically applied preparations [17, 18].
To verify the efficacy and tolerability of Activated Piroctone Olamine (label 100 ml), applied in the management of psoriasis (group I) and with seborrhoeic dermatitis (group II) in patients with significant manifestations of the disease in varying areas of the body (scalp, torso, extremities) of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients.
Randomized, simple controlled triel type III, with post-registration monitoring and continuous inclusion of male and female patients according to criteria
Activated Piroctone Olamine (label 100 ml) applied topically 2 times a day using a system of massaging movements after washing the skin with an indifferent preparationa total of 30 days
Material and methods
Trial centres and numbers of patients:
- Centre 01 – 22 patients with psoriasis and eborrhoeic dermatitis
- Centre 02 – 20 patients with psoriasis and seborrheic dermatitis
- psoriasis or seborrhoeic dermatitis affecting varying areas of the body (scalp, torso, extremities) in varying extent
- outpatient status
- age of 15 to 66 years, male, female
- voluntary participation in the trial
- signed informed patient consent form
- one-time participation in the trial
Specific exclusion criteria
- Usage of other systemic preparation which might influence the final assessment (natural preparations, physical therapy)
- Known allergy to the tested preparation
- Disease focus infection manifestations (superinfection requiring therapy)
- Immunosuppressive therapy
General exclusion criteria:
- Alcohol and drug abuse
- Participation in another clinical trial within the past 30 days
- Simultaneous participation in any other clinical trial
- Other reasons excluding the patient from the trial
- Restricted ability of the patient to follow therapy instructions
- Other physical or mental disorders disturbing the trial plan
- Possible consent withdrawal, presumed patient unreliability
Application regimen: Activated Piroctone Olamine (label 100 ml) applied 2 times a day. Application period: Activated Piroctone Olamine (label 100 ml) is to be applied for at least 30 days, (the preliminary trial was performed 15 days after the last application), allowed deviation of 2 to 3 days.
Information on the application of Activated Piroctone Olamine (label 100 ml), and the application technique: provided by the investigator orally and in writing.
Other measures: drinking regimen and diet: all patients have to be informed of the necessity to adhere to a new drinking regimen and to a diet including the reduced intake of fat, sugar, salt, fizzy drinks, etc.
Documentation: preliminary work protocol, tables, photos taken
Patient tables: continuous recording of the subjective effect on day 0, 15, 30 and 45
Check-ups: day 0, 15, 30, 45 or at exclusion
Basic laboratory screening: according to current need
Special laboratory screening: according to current need
Photodocumentation: pictures taken 2 times in selected patients
Recommended daily hygiene: non-irritating preparations with no influence on therapy
Other medication: only the medication necessary for the basic comfort of the patient, administered exclusively based on recommendation by other medical expert.
Exceptionally, antihistamines were allowed.
Assessment of therapy effect made by the investigator:
Grading scale l – 4
- excellent aesthetic effect, 80 – 100% improvement in skin quality
- satisfactory aesthetic and cosmetic effect, up to 60% improvement in skin quality
- insignificant effect, 30% improvement in skin quality, dissatisfactory aesthetic and cosmetic effect
- unsatisfactory condition, finding in original extent
Subjective assessment of therapy effect on affected areas made by the patient:
Grading scale 1-4
- excellent aesthetic and cosmetic effect, no undesired effects
- satisfactory aesthetic effect
- insignificant improvement, unsatisfactory effect
- unsatisfactory effect
Assessment of tolerability made by both the investigator and the patient:
Grading scale 1-4
(1- excellent, 2 – very good, 3 – good, 4 – intolerance)
Results + comments Seborrhoeic dermatitis
The cohort included a total of 7 patients, 2males and 5 females.
The patients had affected scalp, back of head, neck, and face.
The first included patient was a male – 08122021.
The last scheduled visit was of a female – 01042022.
The affected areas included mainly the scalp and the neck.
The cohort included a total of 7 patients: 2males and 5 females.
The affected areas included the scalp, back of the head, neck and face.
The first included patient was a female – 18012022.
The last scheduled visit was by a female – 22042022.
The affected areas included mainly the scalp and the neck.
The cohort included a total of 15 patients: 3 males and 12 females.
Theaffected areas included the scalp, head, neck, face, torso, and limbs.
The first included patient was a female – 07/12/2021.
The last scheduled visit was by a female – 31/03/2022.
The cohort included a total of 13 patients: 6 males and 7 females.
The affected areas included the scalp, back of the head, neck, face, torso, and limbs.
The first included patient was a male – 17/02/2022.
The last scheduled visit was by a female – 02/05/2022.
The topical therapy of psoriasis vulgaris and seborrhoeic dermatitis is indeed demanding, especially as far as the selection of adequate topical preparationsand systemic drugs is concerned, since they must meet very strict criteria. In addition to pharmaceutical companies, there are companies producing cosmetics, e.g. using thermal water enriched with vitamins or cannabis, which is recently becoming very popular. However, there are strict rules and regulations set out by the EU, which have excluded e.g. picis lithantracis (coal tar) or zinc pyrithionefrom long-term use in topical therapy, which had been often added to shampoos, creams, lotions to meet the needs of patients with psoriasis or seborrhoeic dermatitis. However, these excluded ingredients have been flexibly replaced withPiroctone Olamine. In this case, Catalysis Madrid has made full use of its production potential by innovating the already existing products and using molecularly activated and patented Piroctone Olamine. Already in the past, the spray form has gained extraordinary popularity among customers, especially because of its simple and effective application form.