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ACTIVE TRANSDERMAL DELIVERY BY EPOREX K69 FOR THE CURE OF ACNE
Dr. Elisabetta Sorbellini, Dr. Fabio Rinaldi, Dr. Paola Bezzola
Studio Rinaldi, Milano

The most common skin condition amongst young people is acne, a chronic inflammation of the sebaceous follicles, characterized by black heads, papules, pimples and cysts, often resulting in scars.
Typically occurring during the teenage years with a pick between 14 and 17 years for females and from 16 to 19 years for males. Usually the situation tends to end around 20, however often continues until 35 or 40 especially amongst females with an incidents of 5 % against 1% of the males.

Androgen hormones lead to an overproduction of the sebaceous glands with the result of a change in the microbial microflora and thickening of the skin of the sebaceous duct causing blackheads and inflammation thus having great impact on the social and psychological quality of life.
In an Italian study on 24 persons effected by skin problems, published on the Journal of American Academy of Dermatology, emerged that persons who suffered acne are more propped to suicide on 7% of the cases.

To diagnose acne is easy , however it is more difficult to find the right therapy according to its seriousness, to the expectations and the need of the patient to solve the problem as soon as possible and without possible risk of side effect.

The dermatological therapies use normally antibiotics, retinoids, antibacterial and anti-inflammatory ingredients for topic and systemic use for long periods of time (even months) and have the risk of side effects. During summer some treatments are inadvisable to avoid photosensitization.
These problems brought to a search for equally efficient pharmaceutical treatments but of easier use and less side effect.
An innovation in dermatological therapies field is represented by Active Transdermal Delivery, it permits to deliver active principles of different molecule weights into the skin and to penetrate the dermo-epidermic barrier.
This technique is based on the emission of modulated electromagnetic waves of low energy to avoid unpleasantness during treatments.
The device makes the dermis permeable through the combination of electrical wave and ionization chamber which permits the substances, before mixed with a specific gel, to be electrically charged and so ready for the ionic transport.
The distinctiveness of this technique permits to carry out local therapy using very little substance but obtaining an higher concentration in the target area, so reducing side effects by systemic absorption.
The delivery through the epidermis also reduce local damage of the corneouscithes and epidermic cheratynocites and also reducing the irritation of the skin produced by substances such as rethinoids.
Also, as acne is a form of skin condition that needs treatment of various symptoms, it is possible to mix the gel with a customized cocktail, depending on the type and quantity of the lesions.

We performed a clinical study on out patients to verify the effectiveness of active transdermal delivery of some common pharmaceutical principles and of natural principles, normally used to cure acne through isophoresis with EPOREX K69, and to calculate the duration of the treatment, the kind of side effects that might occur, and the compliance of the treated subjects.

This study was performed on 20 persons: 10 females and 10 males between 14 and 25 years, suffering from minor to medium seriousness of acne according to the Leeds Revised Acne Grading System.
Females were preliminary subjects to blood and hormone tests and a pelvic ultrasound scanning to exclude any endocrine concomitant pathology.
All persons had been previously treated with traditional therapies, even for quite long period of time, however without satisfactory clinical results. Those therapy were suspended six months before the tests.
Digital picture have been taken during the basic visit to be able to valuate the number of acne lesion (blackheads papules pimples) (T0), at the end of the treatment 5-7 weeks later (T1), and at the follow up one month after the suspension of the treatment (T2).
At the same time, also valuations with epiluminescence were carried out on a pre- arranged part of the skin.
Five therapeutic sessions, each of 20 min. per person have been carried out, at one week of distance , followed after 15 days by 2 sessions every 2 weeks.

The aim of our study was to test the real capacity of the device and also of the transdermal delivery technique, therefore a variety of active substances each time inserted in the right combinations, were used depending on the clinical situation of different subjects, in a therapeutic range similar to the traditional topic or systemic applications.
Therefore we have added to the gel, pharmacological ingredients such us clindamicina 1%, retinolic acid 0,05 %, salicylic acid 15%, glycolic acid 8% and natural ingredients such us nipononivea because of its action to inhibit the reductase of the 5 alpha enzyme , plant estrogens, such us genisteina and anti inflammatory ingredients such us beta acid glicirretic or specific combinations of aminoacids.
In the case where there was no presence of pustular lesions we carried out a pre-treatment of skin cleansing by ultrasound, using a spatula shaped handpiece (transducer) equipped with a piezoelectric oscillating system that work at a 25.000 hz frequency, which uses the so called cavitation , on the skin cleansed with mineral water so encouraging the detachment of the superficial corneal cells, preparing the skin for the following treatment: transdermal delivery.
The sessions of 20 minutes each, were well tolerated by the subjects, who showed a little rash at the end of each treatment.

In 2 % of the cases, after 2 sessions an increase of acne has occurred, however solved in the following sessions. In this case it has been necessary to decrease the percentage of sebum reducing and peeling ingredients.
In particular the application of retinolic acid had to be prolonged at larger intervals.

All subjects have responded positively to the treatments with a withdraw of the pathology until its healing up to 90 % of the cases with a maintaining of results even for months after the suspension of the treatment.

No systemic side effects have been verified.
In all cases the subjects were instructed to not assume any photosensitive substances and to not expose themselves to sun or UV lamps, and to apply maximum UVA protection every day and during the whole length of treatment.

Only one case of withdrawal has taken place because of an allergic reaction to one of the ingredients.

Transdermal delivery is no doubt an important innovation in the dermatological field.
In certain skin pathologies it is progressively substituting or used together with the common topic systemic therapies.

The great advantage of this technique is the possibility of using high concentrations of active ingredients directly and only on the target area, in this case the sebaceous glands, reducing to the minimum their circulation in the derma and absorption by other organs.

This determinates its efficiency in an extremely reduction of the duration of therapy , in this way minimize risks of side effects.

The participation of patient is very high because he is not forced to apply daily topic therapies, and normally already after two weeks significant improvement of the proper pathology is noted.