Comfoderm K cream for external use 0.1% tube 30g

Chronic diseases such as atopic dermatitis or eczema are characterized by itchy, dry and easily irritated skin. They are most common in infants and young children, but can persist into adulthood with periodic exacerbations. Some cases are dangerous due to chronic bacterial infections, deterioration in quality of life due to lack of sleep and depression.

Creams and ointments with glucocorticosteroids are the gold standard in the treatment of atopic dermatitis, maximally combining effectiveness and safety. When a hormonal agent is applied topically, there is no general suppression of the immune system, and the therapeutic effect is carried out directly in the affected area.

Comfoderm or Advantan contain a fourth-generation corticosteroid, which gives the most favorable risk-benefit ratio even when used in early childhood. The good efficiency of the new GCS allows you to reduce the application regime to once a day in a thin layer. However, these products have many varieties, which differ in the number of active ingredients in the composition and age restrictions for use.

Comparison of the effectiveness of Advantan and Comfoderm

The effectiveness of Advantan is quite similar to Comfoderm - this means that the ability of the drug substance to provide the maximum possible effect is similar.
For example, if the therapeutic effect of Advantan is more pronounced, then using Comfoderm even in large doses will not achieve this effect.

Also, the speed of therapy - an indicator of the speed of therapeutic action - is approximately the same for Advantan and Comfoderm. And bioavailability, that is, the amount of a drug reaching its site of action in the body, is similar. The higher the bioavailability, the less it will be lost during absorption and use by the body.

Advantan's analogs

Complete analogues of Advantan with the same active ingredient include the following:

• Sterocort;
• Comfoderm;
• Comfoderm K;
• Metizolone;
• Methylprednisolone aceponate.

Such drugs are the best options when looking for a replacement for Advantan.

The list of close group analogues includes the following Advantan substitutes in the form of hormonal creams, lotions, ointments, emulsions with different prices and low hormonal activity:

• hydrocortisone-based products - Highton, Hydrocortisone, Akortin, Hydrocort, Cortade, Lokoid, Laticort;
• analogues with betamethasone - Beta-Val, Valison, Celestoderm, Valoderm, Betnovate, Mesoderm;
• products with desonide - Dezoven, Lokara, Tridesilone;
• drugs with aclomethasone - Afloderm.

In case of severe disease, external topical steroids with moderate and high activity can be used at the beginning of therapy:

• analogues based on triamcinolone - Kenalog, Triacort, Kenalog, Polcortolon, Focort, Cinacort;
• products based on mometasone - Momat, Mometasone, Avecort, Momecon, Silkaren, Elokom;
• analogues with fluocinolone - Sinoderm, Flucort, Flucinar, Fluciderm, Eatsinon, Sinaflan;
• products with betamethasone dipropionate - Belosalik, Diprosalik, Diprozon, Akriderm, Beloderm;
• analogues based on clobetasol - Dermovate, Cloveit, Cloderm, Etrivex;
• Cutivate;
• Westcourt;
• analogue of Cordran.

Treatment is often started with stronger drugs, and as the patient’s condition improves, they are transferred to drugs with low activity.

Combined analogues of Advantan are also used in the form of creams, ointments and other forms for adults and children:

• Akriderm;
• Betaderm;
• Kremgen;
• Lorinden S;
• Trimistin;
• Flucourt;
• Fusiderm B;
• Celestoderm B with garamycin;
• Mycozolon;
• Akriderm GK;
• Pimafucort;
• Candiderm.

Such drugs cannot be considered very close substitutes for Advanatan, since they contain, in addition to the steroid, several other active components, which changes not only the mechanisms of action, but also the effects and indications for use.

List of Advantan analogues with prices

Comparison of safety of Advantan and Comfoderma

The safety of a drug includes many factors.

At the same time, in Advantan it is quite similar to Comfoderm. It is important where the drug is metabolized: drugs are excreted from the body either unchanged or in the form of products of their biochemical transformations. Metabolism occurs spontaneously, but most often involves major organs such as the liver, kidneys, lungs, skin, brain and others. When assessing the metabolism of Advantan, as well as Comfoderm, we look at which organ is the metabolizing organ and how critical the effect on it is.

The risk-benefit ratio is when the prescription of a drug is undesirable, but justified under certain conditions and circumstances, with the obligatory observance of caution in use. At the same time, Advantan does not have any risks when used, just like Comfoderm.

Also, when calculating safety, it is taken into account whether only allergic reactions occur or possible dysfunction of the main organs. In other matters, as well as the reversibility of the consequences of using Advantan and Comfoderm.

Comparison of addiction between Advantan and Comfoderma

Like safety, addiction also involves many factors that must be considered when evaluating a drug.

So, the totality of the values ​​of such parameters as “syndrome o” in Advantan is quite similar to the similar values ​​in Comfoderm. Withdrawal syndrome is a pathological condition that occurs after the cessation of intake of addictive or dependent substances into the body. And resistance is understood as initial immunity to a drug; in this it differs from addiction, when immunity to a drug develops over a certain period of time. The presence of resistance can only be stated if an attempt has been made to increase the dose of the drug to the maximum possible. At the same time, Advantan has a fairly low “syndrome” value, just like Comfoderm.

Elidel and corticosteroids: allies or rivals?

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Topical corticosteroids (CS) are the basis for the treatment of atopic dermatitis (AD), as they have anti-inflammatory, immunosuppressive and antiproliferative properties. These drugs act quickly and effectively, which satisfies both the doctor and the patient. However, steroids have a number of serious side effects. Systemic complications are especially dangerous, developing, as a rule, as a result of the absorption of drugs from large-area lesions with prolonged use. The No. 1 risk group in this regard is children under 2 years of age, whose skin permeability is much higher than that of adults [1]. The most serious systemic complications include inhibition of the hypothalamic-pituitary-adrenal system and associated growth retardation, Cushing's syndrome, hypertension, and diabetes [2–6]. Long-term use of topical steroids carries a risk of immunosuppression, manifested by bacterial, viral, and fungal infections. These effects are predominantly characteristic of early generations of CS, especially fluorinated CS. In recent decades, drugs have been created whose absorption when applied externally does not exceed 1%, however, they also have a number of disadvantages. Among local complications, skin atrophy, striae, telangiectasia, pigmentation disorders, and acneiform rashes predominate [7]. Important disadvantages of external CS include tachyphylaxis - addiction and loss of effectiveness.

All these side effects and complications have led to the fact that 73% of patients with AD suffer from the so-called “steroid phobia” - anxiety of varying degrees, up to a complete refusal to use CS [8]. For this reason, 24% of adult patients and 36% of parents of sick children admit to violating the external therapy regimen. “Steroid phobia” affects not only patients, but also doctors themselves, so treatment with these drugs is often started late, the duration of therapy is insufficient, and the doses, especially in children, are too small. All this leads to inadequate relief of exacerbation, early relapse and the formation of tachyphylaxis.

In this regard, the question arises: how to shorten the period of use of CS during exacerbation of blood pressure and at the same time prolong the remission of the disease?

To solve this problem, a selective inhibitor of the synthesis and release of proinflammatory cytokines, pimecrolimus (SDZ ASM 981), is currently used. It has been established that this substance is in vitro

selectively binds to macrophilin-12, and inhibits calcineurin and thereby the synthesis of inflammatory cytokines in T cells (IL-2, INF-g), as well as the release of inflammatory mediators (for example, histamine) from mast cells [9–12]. At the same time, pimecrolimus does not affect keratinocytes, fibroblasts, endothelial cells and Langerhans cells. In vivo, the drug has high anti-inflammatory and slight immunosuppressive activity [9–12] and does not cause atrophy [13]. Pimecrolimus has a high affinity for the skin, therefore it penetrates well into it and practically does not penetrate the skin [11].

Clinical trials have established the safety and effectiveness of 1% pimecrolimus cream - Elidel® (Novartis, Switzerland) for short-term and long-term use in children and adults with AD.

In order to try to reduce with the help of Elidel the frequency and duration of relapses and the dependence of patients on external CS for blood pressure in adults, a multicenter, double-blind, randomized controlled trial lasting 24 weeks was conducted [14].

We observed 192 patients with AD aged 18 years and older. The diagnosis was made in accordance with the criteria of Hanifin [15] and Rajka [16]. The affected area before treatment was at least 5%, with an average of 17% in both groups. In each group, patients with moderate AD predominated (3 points on the IGA scale).

Based on the results of randomization, 96 patients were included in the main group and 96 in the control group. There were no statistically significant demographic or clinical differences between the groups (Table 1).

Patients in the main group received external treatment with Elidel cream 2 times a day, while patients in the control group received only the base of the cream. In the first week of the study, this treatment regimen was mandatory. Subsequently, in case of exacerbation, external CS (prednicarbate 0.25% cream) was prescribed twice a day for 7 days and once a day for the next week. After CS therapy, treatment with the study drug was carried out for another 1 week to relieve residual symptoms of exacerbation (Table 2). The main efficacy criterion was the number of days (%) during which CS were used for acute treatment of exacerbations. Additional evaluation of effectiveness was carried out according to the following parameters: number of exacerbations, IGA results, EASI, itching intensity. The last parameter was assessed by the patients themselves, using the following point scale: 0 – no itching, 1 – slight itching, 2 – moderate itching, 3 – severe itching, 4 – very severe itching. Tolerability was assessed based on clinical and laboratory data.

Patients were examined during the initial examination, and then at 1, 3, 6, 12 and 24 weeks of treatment. In addition, additional telephone contact was carried out at 9 and 18 weeks. In cases of severe exacerbation, unscheduled examinations were performed.

results

In the main group of patients treated with Elidel cream, a statistically significant (compared to the control group) reduction in the number of days during which patients were forced to use CS was recorded (Fig. 1).

Rice. 1. Number of days patients used corticosteroids (%)

In the main group, patients used CS on average for 14.2% ± 24.2% of 168 days (total study duration), and in the control group - in 37.2% ± 34.6% (p < 0.001). Moreover, half of the patients receiving Elidel did not require the use of CS for the entire 24 weeks (Fig. 2).

Rice. 2. Number of days patients required treatment with topical corticosteroids (%)

The frequency of exacerbations and time to first exacerbation also differed significantly between the two groups of patients. In the main group, on average, 1.1±1.4 cases of exacerbation were registered, in the control group – 2.4±2.3 (p<0.001). Almost half (44.8%) of patients treated with Elidel showed no exacerbations for six months. In persons receiving traditional therapy, this figure was 18.8% (Fig. 3.4).

Rice. 3 Frequency of exacerbations (%)

Rice. 4. Time until first exacerbation

When assessed on the IGA scale, 82.3% of patients in the main group showed an improvement of at least one point versus 51.0% in the control group, and the EASI score decreased by an average of 48.3% versus 15.9% (respectively) (p<0.001) . Among patients treated with Elidel, half as many people stopped treatment due to its ineffectiveness compared to traditional therapy (15.3% and 27.1%, respectively).

The dynamics of itching are presented in Figure 5. Noteworthy is the decrease in itching during the first three days of therapy in the main group and a temporary increase in the control group.

Rice. 5. Dynamics of itching during the first week of treatment

Elidel cream was well tolerated by patients; pathologies in traditional laboratory tests were not detected in any of the patients throughout the study.

Thus, external treatment of patients with blood pressure with Elidel cream allows:

• reduce the use of local CS or completely abandon them,
• reduce the number of exacerbations,
• increase the duration of the period without exacerbations of blood pressure,
• leave the CS as a reserve for short courses of treatment for exacerbation of blood pressure and minimize the risk of complications from long-term steroid therapy,
• improve control of the disease in general, the general well-being of patients, and, consequently, the quality of life of patients.

References:
1. Giusti F, Martella A, Bertoti L, Seidenari S. Skin Barrier, Hydration, and pH of the Skin of infants under 2 years of age. Ped Derm 2001; 18:93–6.

2. Keipert JA, Kelly R. Temporary Cushing's syndrome from percutaneous absorption of betamethasone-17-valerate. Med J Austr 1971; 1:542–4.

3. Pascher F. Systemic reactions to topically applied drugs. Int Dermatol 1978; 17: 768–75.

4. Bode HH. Dwarfish following long long–term topical corticosteroid therapy. JM Med Assoc 1980; 244:813–14.

5. Bartorelli A, Rimondini A. Severe hypertension in childhood due to prolonged skin application of mineralocorticoid ointment. Hypertension 1984; 6:586–8.

6. Walsh P, Aeling JL, Huff L, Weston WL. Hypothalamus–pituitary–adrenal axis suppression by superprotent steroids. J Am Acad Dermatol 1999; 29:501–3.

7. Fisher DA. Adverse effects of topical corticosteroid use. West J Med 1995; 162:123–6.

8. Charman C, Morris A, Willians H. Topical corticosteroid phobia in patients with atopic dermatitis. Br J Dermatol 2000;142:931–6.

9. Meingassner JG, Grassberger M, Fahrngruber H et al. A novel anti–inflammatory drug, SDZ ASM 981, for the topical and oral treatment of skin diseases: in vivo pharmacology. Br J Dermatol 1997; 137:568–76.

10. Grassberger M, Baumruker T, Enz A et al. A novel anti–inflammatory drug, SDZ ASM 981, for the treatment of skin diseases: in vitro pharmacology. Br J Dermatol. 1999 Aug;141(2):264–73

11. Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel(, SDZ ASM 981) – Preclinical pharmacological profile and skin selectivity. Seminars Cutan Med Surg 2001; 20(4):233–41.

12. Zuberbier T, Chong SU, Grunow K et al. The ascomycin macrolactam pimecrolimus (Elidel, SDZ ASM 981) is a potent inhibitor of mediator release from human dermal mast cells and peripheral blood basophils. J Allergy Clin Immunol. 2001 Aug; 108(2): 275–80.

13. Queille–Roussel C, Paul C, Duteil L et al. The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double–blind controlled study. Br J Dermatol. Mar 2001; 144(3): 507–13.

14. Meurer M, Folster–Holst R, Brautigam M. Pimecrolimus (SDZ ASM 981) cream reduces the need for corticosteroids in the long–term management of atopic dermatitis in adults. Study, presented at the 60th annual meeting of the American Academy of Dermatology in New Orleans, USA, February 2002

15. Hanifin JM, Thurston M, Omoto M et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. Feb 2001; 10(1): .11–8.

16. Rajka G. Natural history and clinical manifestations of atopic dermatitis. Clin Rev Allergy. 1986 Feb; 4(1): 3–26.

Comparison of side effects of Advantan and Comfoderma

Side effects or adverse events are any adverse medical event that occurs in a subject after administration of a drug.

Advantan has almost the same side effects as Comfoderm. They both have few side effects. This implies that the frequency of their occurrence is low, that is, the indicator of how many cases of an undesirable effect of treatment are possible and registered is low. The undesirable effect on the body, the strength of influence and the toxic effect of Advantan are similar to Comfoderm: how quickly the body recovers after taking it and whether it recovers at all.

Which is better - Comfoderm or Advantan

Comfoderm is not recommended for pregnant women and is strictly prohibited for minors. Despite this, the drug is considered highly effective, with a low risk of adverse reactions if the dosage instructions are fully followed.

Advantan can be used for infants and older children.

This is due to the fact that it does not contain urea; it contains other excipients that do not have a negative effect on the child’s body. Therefore, most doctors recommend purchasing Advantan.

If the patient is an adult with dermatitis or eczema, there is no difference in the use of products. But this only applies to cream or ointment. When an emulsion is needed, only Advantan can be purchased.