CLINICAL STUDY ON THE USE OF PHOSPHATYLCHOLINE–BASED PATCHES AND GELS

Professor Tommaso Addonisio

Dermatologicical Surgeon and Cosmetic Doctor

President, S.I.M.B.E.N. (Italian Society for Medical Welfare)

Scientific Editor, “Benessere & Salute” (Health & Welfare) Magazine

Professor of Dermatological Laser Surgery and Treatments for Aging Skin,

Faculty of Medicine and Surgery, University of L’Aquila, Italy

Professor of Masters Course in Cosmetic Medicine,

Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy

Masters in Medical Welfare,

Federico II University, Naples, Italy

www.simben.it

DEVELOPMENTS IN THE USE OF PHOSPHATYLCHOLINE AS A TREATMENT FOR CELLULITE

The term “cellulite” is usually used to refer to an increase in size of various parts of the body (most frequently the upper and outer surface of the thigh). The term is often incorrectly used to refer to various physical changes, which comprise:

edematous-fibrosclerotic panniculopathy (EFSP), an excess of localised adipose tissue (fat) and an accentuation of hip and thigh fat (‘gynoid habitus’, or the tendency for body fat to be concentrated below the waist).

ORIGINS AND DEVELOPMENT

The origins and development of EFSP can be subdivided into four phases or stages:

1st Stage: Edema. A change in capillary permeability causes a leakage of plasma which then accumulates in the small spaces between the adipocytes (the cells that make up adipose tissue, or fat), thereby causing an edema (excessive accumulation of serum in tissue spaces or body cavities).

2^nd Stage: Hypertrophy of the reticular fibres. This is characterised by fatty lobules caused by the edema.

3rd Stage: Characterised by the formation of micronodules. The hypotrophic reticular fibres incorporate the adipocytes, creating fibrous nodules and fatty lobular tissue.

4th Stage: Characterised by the formation of macronodules. The appearance of these macronodules is due to the presence of the hypertrophic reticular fibres which incorporate the adipocytes. It is also possible to note the appearance of widespread liposclerosis, comprising dermal sclerosis, introflection and cutaneous atrophy.

All these changes give rise to the so-called ‘orange peel’ effect.

The main factors contributing to the development of EFSP are: obesity, a sedentary lifestyle, lack of muscle mass, pregnancy, certain types of medication (such as calcium channel blockers, used to treat problems with the heart and circulatory system; peripheral vasodilators used to reduce blood pressure; and contraceptives) and genetic predisposition.

A sedentary lifestyle is a predisposing factor in the onset of EFSP because it creates an imbalance between the forces that impel the venous blood flow around the body to the centre, with consequent venolymphatic stagnation of the lower limbs.

Furthermore, while increasing capillary permeability, estrogen plays a large part in increasing fluid retention and venous return (blood going back to the heart). Clinical evaluation comprises an objective examination of tissue samples, looking particularly at a number of important morphological aspects, including the colour and appearance of the skin, its elasticity and texture, how easy it is to lift by pinching it, the presence of teleangiectasia (the visible enlargement of small blood vessels.) and nodules of varying degrees of painfulness.

When pressure is applied to affected areas with the fingers, any resulting pain is due to venous stasis, while pain as a result of pinching the affected tissue is due to the compression of nerve endings caused by the edema.

We must also consider the important role played by posture in the origins and development of EFSP. It is crucial to study the way the way the foot is placed on the ground when walking, as incorrect and uncorrected positioning can alter the pressure applied to the sole of the foot, which when pushed against the ground is insufficient to ensure the correct circulation of blood around the lower limbs. This is the first cause of any change to venolymphatic circulation and the subsequent appearance of EFSP.

Phosphatylcholine has been used intravenously since 1965 to treat liver disease.

HISTORY OF THE USE OF Phosphatylcholine

For years, phosphatidylcholine was used as a drug to combat hypercholesterolemia (high blood cholesterol) and hyperlipidemia (raised or abnormal levels of lipids in the blood), while its use as a technique for lipolysis was introduced in clinical practice in 1995 by a Brazilian dermatologist, Dr. Rittes.

Phosphatidylcholine is a component of cell membranes and it performs both a structural and functional role. However, its most important role is to ensure that the cell membrane remains undamaged, and as a natural substance, derived from soya lethicin, it performs an emulsifying role.

METHODS OF APPLICATION

When injected into fatty tissue, phosphatidylcholine is able to make fat soluble by reducing the volume of adipocytes.  It is injected directly into areas where fat has accumulated with thin needles, which are inserted to a depth of about 1 cm.

The treatment area must be marked out and the substance should be applied in such a way as to achieve its homogeneous distribution.

Despite its effectiveness, this method has a number of disadvantages, including inflammatory reactions associated with necrosis, atrophy, the formation of microcysts and acute pain in treated areas which has been known to last 7-10 days following its administration.

Phosphatidylcholine injections do not pose any health risks to the patient, but in order to avoid the aforementioned side effects, a number of innovative products such as disposable phosphatidylcholine-based patches or phosphatidylcholine gels are now available.

The active ingredients of these products are gradually and steadily released. The patch and gel can be applied to the stomach, hips, ‘saddle bags’, arms, the inner thighs and the knees. It is not recommended to apply these products to the face.

Professor TOMMASO ADDONISIO (President of S.I.M.B.E.N., the Italian Society for Medical Welfare) conducted a study analysing the effectiveness of phosphatidylcholine-based patches and gels. The aim was to measure in centimetres the reduction of edematous-fibrosclerotic panniculopathy (EFSP) and/or localised adipose tissue (fat) on the areas of the body where the patch or gel was applied. The study started following careful consideration of the patients’ medical histories, conducted to ensure the absence of illness or disease and to test for any dermatological reactions to the patches and gels.

The subjects of the study were 20 women aged between 25 and 50, with various stages of cellulite. Measurements were taken of the circumference of each woman’s thighs, stomach and hips and the suprailiac area just above the hip bone, using skinfold callipers. Each participant applied the patches and gel at home on alternate days, leaving them on the treated areas for 6/8 hours (ideally in the evening before going to bed).

Table 1           Data collected following a month’s treatment of phosphatidylcholine-based patches and gels

Average reduction of circumference in cm

- Reduction in the circumference of the right thigh of 2.5cm

- Reduction in the circumference of the hips of 3.8cm

A significant reduction was noted in the circumference of the thighs and hips treated, varying from 2-4.5cm, and also a reduction in the measurements taken of the suprailiac area of between 3-5cm.

Table 2           Percentual correlation showing the reduction of body weight, suprailiac area measurement and thigh circumference

- Reduction in cm of suprailiac area measurement 45%

- Reduction in cm of thigh circumference 46%

- Reduction in body weight 9%

A further reduction was recorded of between 1-3cm around the thigh and hips and 2-3cm of the suprailiac area measurement.

Table 4           Data collected after 3 months of treatment with phosphatidylcholine-based patches and gels

Average reduction of circumference in cm

- Reduction in the circumference of the right thigh of 0.5cm

- Reduction in the circumference of the hips of 1cm

The third and final test, which took place 3 months after the first application, showed a further reduction of between 1-1.5cm in the circumference of the thighs and hips and of between 0.5-1cm in the measurement of the suprailiac area.

In conclusion, we can say that based on the medical tests carried out by our team after 1 and 2 months of treatment, the patches proved to be undoubtedly effective in the home treatment of cellulite and fatty deposits as well as being practical and user-friendly.

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