External therapeutic agent for patients suffering from atopic dermatitis

FIELD: medicine.

SUBSTANCE: agent contains 0.2% Pyriton, an emulsifier, an emollient - isopropyl myristate, and a solvent. The emulsifier is presented by glycerol cocoate PEG-7; the emollient is presented by triglycerides of caprylic and capric acids; the solvent is water. Besides, the agent additionally contains glycerol, cyclomethicone, urea, allantoin and a flavouring agent. All the ingredients of the agent are taken in certain mass ratio.

EFFECT: invention enables eliminating side effects, recovering physiological properties of skin and providing high patient's satisfaction upon completion of the treatment.

1 tbl, 1 ex

 

The invention relates to medicine, namely to dermatology, and can be used for the treatment of patients with atopic dermatitis (AD).

Known means for external use in the treatment of atopic dermatitis in the form of aerosols.

One of these drugs is Skin-cap spray (trade name SKIN-CAP) for external use in the form of an oily solution from white to yellow to light yellow in color with a characteristic smell. 100 g contains: active substance - activated zinc pyrithione 0.2% and excipients sodium lauryl sulfate, isopryl myristate, ethanol and the propellant (isobutane, propane and butane) (instructions for medical use of the drug Skin cap spray, "Cheminova Internacional S.A. Macarena, 14, 28016 Madrid, Spain, General representative - OOO INVAR", Russia, Moscow., code ATX: D11AX12, registration №P N012231/03, 10.03.2005 site INVAR 2006-2012 - WebProvision).

However, this drug can cause allergic reactions in people with hypersensitivity to the components of the drug, in patients with atopic dermatitis - a redness and burning (hypersensitivity reaction aerosol Skin-KAP) (Kulagin, VA, Secret A.G., Pavlova O., Nikiforova GD, Arutyunov Y.S. Steroid external therapy activated zinc pyrithione atopic dermatitis is of psoriasis in children. Pediatrics them. G.N. Speranskii, 2005;6:57-61).

Other external means in the form of an aerosol and the closest to the claimed composition is an aerosol spray for topical application ZANOCAP in the form of an oily liquid white to light-yellow color with a specific smell, including 2 mg (0.2%) piriton zinc and excipients: sodium laurylsulfate, isopropylmyristate-emollients, colloidal silicon dioxide (Aerosil) - emulsifier, dexpanthenol (D-pathenol), Polysorbate 80 (tween 80) - emulsifier, ethanol (ethyl alcohol) - solvent and Tetrafluoroethane (HFC 134) (instructions for use of the drug CHINOCUP, JSC Pharmstandard-LEKSREDSTVA, Russia, code ATX: D11AX12, registration No. LSR-010497/08, 24.12.2008 - Medical Handbook. Directory of drugs., website: medicalhandbook.ru|catalog-lekarstv/ 03/12/12) prototype.

The drug used in the treatment of psoriasis, atopic dermatitis, seborrheic dermatitis, however, can also cause allergic reactions and are not well tolerated by patients. Thus, according to A.A. Tikhomirov and N.G. Short (2011) using aerosol Zanocap in patients with atopic dermatitis were observed phenomena intolerance of the drug, leading to discontinuation of treatment; some patients had a burning sensation of the skin after application of the drug, was revealed its "satisfactory" per Novosti in 15.8% of patients, and 10,5% - tolerability was assessed as "bad" (Tikhomirov A.A., Short N.G. Atopic dermatitis in children - the strategy and tactics of rational pharmacotherapy. -Questions of practical Pediatrics. 2011; 6(2); 58-62).

With high probability the reason for the formation of adverse events and poor endurance aerosol Zanocap is the presence in its composition of HFC 134a and ethanol (ethyl alcohol), which actively evaporate in contact with the irritated skin of a patient with atopic dermatitis, causing further irritation and dryness.

The objective of the invention is to develop a tool external therapy for patients with atopic dermatitis in miracidial period, providing anti-inflammatory and simultaneously moisturizing, protective and softening effect on the skin of patients with atopic dermatitis.

The technical result that will be achieved from the use of this invention is the removal of the side effects, restoring the physiological properties of the skin and in providing high patient satisfaction after treatment.

The technical result is achieved by the means of external therapy for patients with atopic dermatitis, including zinc, piriton of 0.2%, emulsifier, emollient - isopropylmyristate and the solvent, as an emulsifier COI is lsout literallayout PEG 7, as emollients in addition use the triglycerides of Caprylic and capric acids, the solvent is water, and optionally add glycerine, philomathean, urea, allantoin and flavouring in the following ratio, wt.%:

Zinc pyrithione- 0,2
Literallayout PEG- 7-9,0
Glycerin- 2,0
Cyclomethicone- 2,0
Urea- 1,5
Isopropylmyristate- 1,0
Triglycerides of Caprylic and
capric acid- 1,0
Allantoin- 0,5
Flavor- 0,08
Water- rest

The invention consists in the combination of these components.

Used as emulsifier of literallayout PEG-7 provides) is their water and fat components of external therapy.

Use as emollients, along with isopropylmyristate, triglycerides of Caprylic and capric acids not only creates a protective film on the skin, but also leaves the skin feeling soft and silky.

The use of oxygenated glycerol serves to moisturize the skin, does not cause complications with the liver and kidneys, and does not cause allergies.

Use tsitologiia provides skin nutrition and allantoin has a skin softening effect.

Urea in the composition of the means of external therapy is used as an additional active substance is a keratolytic.

The flavor in the composition of the funds injected to produce a pleasant smell.

Use as a solvent water is necessary for the formation of optimal consistency.

Qualitative and quantitative composition of the components is chosen experimentally.

From the analysis of scientific-technical and patent literature, inventive combination of components that provide anti-inflammatory, moisturizing, protective and softening effect on the skin of patients with atopic dermatitis in miracidial period without side effects, we have not identified, allowing to draw conclusions on the conformity of the proposed solutions to the criteria of "novelty" and "inventive step". The invention is carried out after the respective way. On the scale set 2 chemical glass. In the first glass is poured 165.0 g (82,72 wt.%) water, 4.0 g (2.0 wt.%) glycerol, and 1.0 g (0.5 wt.%) allantoin. The second glass contribute PEG-7 literallayout 18.0 g (9.0 wt.%); cyclomethicone 4.0 g (2.0 wt.%); isopropylmyristate 2.0 g (1.0 wt.%); triglycerides of Caprylic and capric acid 2.0 g (1.0 wt.%) and urea 3.0 g (1.5 wt.%).

Content 1 Cup (aqueous phase) add the contents of the second beaker (fatty phase) and mix them. After receiving the emulsion added 0.16 g (0.08 wt.%) flavoring and 0.84 g of 48%suspension of zinc pyrithione (which corresponds in terms of pure zinc pyrithione 0.2 wt.%) and mix. Thus prepared external means are placed in plastic bottles with pump dispenser and is used to treat patients with atopic dermatitis.

For the characterization of therapeutic action of new external funds and parameters of its portability used "participant Questionnaire clinical trials a new drug to patients with atopic dermatitis in miracidial period, involving the assessment of the characteristics of the skin and the severity of possible side effects when applying a new external funds, only 12 signs with objective assessment of clinical data using visual analogue scales (VAS) from 0 to 10 points (Danilychev I., Ilyina I Quality of life in patients with urticaria and atopic dermatitis. Consilium Medicum. 2001; V. 3(No. 4);C. 184-186).

The claimed means of external therapy (in the form of a spray) is used for the treatment of patients with atopic dermatitis mild in miracidial period (n=13), while the standardized index SCORAD severity of the disease before treatment was 7.4±1.8 points. The comparison group consisted of patients (n=13) atopic dermatitis mild, before treatment average index SCORAD was of 7.7±1.3 points, that is, were not statistically different from the main group. Patients in the comparison group as external funds used aerosol Zanocap (the prototype). After a 4-week course of therapy in both groups was assessed residual symptoms of atopic dermatitis doctor and studied subjective evaluation of the patients underwent external treatment, assessment factors commitment therapy.

Clinical example

Patient, 23 years of age, system administrator, suffers from HELL one year of age, when they began to appear frequently (2-4 times per year) to recur manifestations of HELL in the face, neck, upper extremities. Was treated at the place of residence at the pediatrician, externally used hormone creams and ointments (usually alclometasone) long courses with a moderate effect. With over 15 years of age who recovered from a diagnosis of bronchial asthma, with which the patient is monitored by a specialist allergist. Cutaneous manifestations of adolescence recur 1-2 times per year in the form of acute eczema of the hands, which is a typical manifestation of the adult phase of HELL.

The process with a small area of the lesion (2.0% of body surface), light form, with registration index SCORAD from 6.2 to 8.0 points). In the period of exacerbation of the clinical picture is dominated by the phenomenon of hyperemia, edema, focal soak, itchy skin. The patient refuses treatment hormonal method (corticosteroid creams and ointments), uses only phytotherapeutic means in the form of lotions and baths, then notes the decrease itching and redness, however, complains of dry skin, and feeling of tightness.

The next bout in August 2012 taken treatment without effect. The patient was assigned to declare external means in the form of spray 2-3 times a day on the skin of the rear brush. On the 3rd day was a decrease redness and swelling in the areas, areas soak regressed. The use of local irrigation new external tool in the form of spray was continued up to 4 weeks. Clinical observations and the results of the survey of the patient (see table) showed that the use of new external funds led to a complete regression of symptoms, the nature of which was rituals by the absence of undesirable consequences in the form of dryness, peeling, skin tightening. The patient actively expressed an opinion about the good tolerability of the new tools, about the convenience of its application (no excessive lipid film on the skin surface), resulting in the application of the new tools was continued in one shot mode, causing 1 time per day). Currently, clinical remission of dermatosis in a patient persists for 3 months.

The results of comparative studies on the evaluation of the characteristics of the skin, side effects and tolerability of the use of the claimed external funds in the form of spray and aerosol Zanocap (prototype) in the Table.

-
Table
Symptoms (% of patients)The inventive tool (spray)
N=13
Aerosol Zanocap N=13
Assessment timeDryness7,7%23,1%
The feeling of tightening of the skin7,7%30,8%
Itching-7,7%
Burning skin15,4%
Redness-15,4%
The swelling of the skin-7,7%
Peeling skin7,7%23,1%
Small pustules--
PatientGeneral discomfort-23,1%
Tolerability is good, good92,3%69,2%
Satisfaction from the use of medication100,0%73,3%
Overall patient satisfaction properties of the skin after the treatment100,0%69,2%

Comparative studies have revealed significant superiority of the new external funds, whose use in patients with AD 4.0 times less than in the treatment of aerosol Zanocap were recorded sense of the banner is of the skin; 3.0 times less dryness and flaky skin. The new tool does not cause itching, burning, redness and swelling of the skin, whereas the aerosol Zanocap caused these phenomena. According to patients using a new external tool (in the form of a spray) did not cause discomfort, then as a means of comparison caused this condition in 23.1% of patients. New external agent is characterized by a great and good tolerability (92,3%), high satisfaction from the use of the drug and total patient satisfaction properties of the skin after treatment (100%).

Means external therapy for patients with atopic dermatitis, including zinc piriton of 0.2%, emulsifier, emollient - isopropylmyristate and the solvent is notable as it contains the emulsifier literallayout PEG 7, as emollients further comprises triglycerides of Caprylic and capric acid, as solvent, water and optionally contains glycerin, cyclomethicone, urea, allantoin and flavouring in the following ratio, wt.%:

tr>
Zinc pyrithione- 0,2
Literallayout PEG-7- 9,0
Glycerin- 2,0
Cyclomethicone- 2,0
Urea- 1,5
Isopropylmyristate- 1,0
Triglycerides of Caprylic and
capric acid- 1,0
Allantoin- 0,5
Flavor- 0,08
Water- rest



 

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