Дермазол

Quick links to important sections

Дермазол

Selected form

Method of action: Antitumour

Treatment option: Dermatitis, Infection

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Дермазол

What is Дермазол? (Dermasol/Dermazole)

Дермазол is a recognized family of topical medicines used to treat various skin and scalp conditions. The most common formulations of the brand feature the active antifungal agent Ketoconazole, typically in a 2% concentration, classifying it as an imidazole antifungal agent. These products are primarily used for their ability to combat the fungal and yeast organisms responsible for common dermatological issues.


Quick Facts

Property Description
Active Ingredient Ketoconazole (most common formulations)
Form Cream, Shampoo, or Gel
Pharmacological Class Imidazole Antifungal
Common Use Seborrheic dermatitis, Tinea infections, Pityriasis Versicolor
OTC/Rx Status Generally Over-the-Counter (OTC) for topical use

The main function of Дермазол formulations containing Ketoconazole is to treat conditions like seborrheic dermatitis (dandruff), ringworm (tinea), and tinea versicolor. The active ingredient is clinically recognized for selectively eliminating the overgrowth of yeast, particularly Malassezia furfur, which often triggers scaling and inflammation on the scalp and body.

Topical formulations are noted for their safety profile, as the minimal absorption into the body allows for continued use in contrast to oral forms. This positioning makes Дермазол a reliable, locally acting solution for fungal skin infections.

What side effects are possible with Дермазол?

Possible Side Effects and Safety Information

The safety profile for topical Ketoconazole (Dермазол) formulations is primarily defined by localized skin reactions due to the minimal systemic absorption of the active ingredient, as documented by regulatory authorities (e.g., EMA/SmPC, FDA). Adverse reactions are classified by frequency, based on clinical trial and post-marketing data.


Documented Adverse Reactions by Frequency

Classification Common Reactions (≥ 1/100 to <1/10)
Primary Application site pruritus (itching)
Primary Skin burning sensation
Primary Application site erythema (redness)

Uncommon Reactions (≥ 1/1,000 to <1/100) include contact dermatitis, bullous eruption, rash, skin exfoliation, and irritation at the application site. Reactions such as Angioedema and Urticaria (hives) have been reported and are classified as Not Known (frequency cannot be estimated from available data), often linked to hypersensitivity.


High-Level Safety Considerations

The most important safety constraint is a strict contraindication for individuals with a known history of hypersensitivity to Ketoconazole or any component in the formulation.

Unlike the oral version, regulators generally note that the topical formulation is not associated with severe systemic effects (e.g., liver or adrenal toxicity). Safety notes for Pregnancy and Lactation indicate that risks are not known for topical use, as plasma concentrations of the drug are typically non-detectable following application in adults. Certain excipients within the cream formulation, such as cetyl alcohol and stearyl alcohol, may cause localized skin reactions.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory classification for overdose with topical Ketoconazole (Дермазол) centers exclusively on the risk of accidental oral ingestion of the formulation. Due to the active ingredient's negligible percutaneous absorption, the official prescribing information does not document systemic toxicity manifestations, such as hepatotoxicity or adrenal suppression, following topical application or its overdose.

The primary concern is the potential physical hazard associated with swallowing the product. In the event of known or suspected accidental ingestion, the label-mandated action is to seek immediate medical attention and contact a Poison Control Center. Treatment is strictly defined by regulatory guidance as involving supportive and symptomatic measures only, as no specific antidote is known.

A critical procedural prohibition is also officially stated: to prevent the documented risk of aspiration, medical interventions such as inducing vomiting (emesis) or performing gastric lavage must not be performed. The overall regulatory structure defines the emergency need for medical help as being triggered by the ingestion event, rather than by expected drug-related systemic symptoms.

Therapeutic Uses of Дермазол

What Дермазол Treats: Main Uses and Benefits

This medication is commonly used to help with fungal skin infections and manage scaling conditions. Дермазол is generally applied across domains where additional symptomatic support is needed and is relevant in clinical contexts involving heightened discomfort to provide relief from distressing and visible manifestations.

This medication is relevant for easing chronic scaling and flaking associated with seborrheic dermatitis (dandruff), red, scaly rashes from tinea infections (like ringworm, jock itch, and athlete's foot), and skin discoloration seen in pityriasis versicolor. It helps address symptom clusters that may become intense or disruptive, offering symptomatic relief that assists patients with maintaining functional stability.

“It is commonly used across conditions presenting with acute or episodic manifestations, providing supportive relief when symptoms interfere with routine activities.”

The therapeutic benefit provides support that helps ease the overall symptom burden, and is relevant for easing recurrent manifestations.


Quick Fact: Support for Inflammatory Fungal Symptoms The medication is considered relevant for easing symptoms related to inflammatory or irritative states and physical discomfort. It is applied when these conditions produce significant symptomatic burden, helping to ease the overall symptom load and assists with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

The eligibility for using topical Дермазол (Ketoconazole) is determined by regulatory criteria, focusing strictly on patient population and physiological status.

Contraindications and Restrictions

Category Official Regulatory Status
Absolute Contraindication Individuals with a known hypersensitivity or allergy to ketoconazole or any component (excipient) of the specific topical formulation.
Age-Group Limitation Children under 12 years of age, as safety and effectiveness have not been established for this pediatric population in most topical product labels.
Conditional Use Patients previously using topical corticosteroids must gradually withdraw the steroid to avoid a potential rebound effect before initiating Дермазол.

Physiological and Comorbidity Status

Use is generally permitted for adults and older adults with no specific dose adjustments required. For systemic conditions, such as renal or hepatic impairment, no specific restrictions are documented for topical use due to the minimal systemic absorption of the medicine.

Regarding Pregnancy, use is generally considered acceptable or Category C (US FDA), indicating it should be used only if the potential benefit justifies the potential risk. Lactation (Breastfeeding) use is also considered low-risk given the minimal systemic absorption, though caution is still advised.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation for topical Ketoconazole (Дермазол) confirms that its interaction profile is significantly limited due to minimal systemic absorption. This characteristic prevents the medicine from causing the major drug-drug interactions associated with oral antifungal agents, particularly those involving liver enzyme systems.


Systemic Interaction Profile

Interaction Type Regulatory Status (Topical Use)
Contraindicated Combinations None formally listed
Pharmacokinetic (CYP/Transporter) None documented as clinically relevant
Interactions with Food/Alcohol None documented

Administration Pattern Management

The only specific interaction-related constraint documented in official product labeling concerns the required administration schedule when initiating treatment in patients who have been using potent topical corticosteroids.

  • Timing Rule: The regulatory requirement is to gradually reduce and eventually discontinue the potent topical corticosteroid when beginning treatment with topical Ketoconazole. Immediate cessation of corticosteroids is not recommended by regulatory bodies, as this may lead to a rebound phenomenon (a temporary return or worsening of symptoms).

This required sequence is defined as a timing-based administration restriction, designed to manage the patient's transition from one class of topical therapy to another without severe symptomatic exacerbation. The topical formulation does not otherwise require any timing separation or dose adjustments for co-administered systemic medicines.

Mechanism of Action

The mechanism of action for Ketoconazole, the active ingredient in Дермазол, is a highly specific process targeting the fundamental structure of the fungal cell. It works within the mechanistic domain of enzyme-mediated fungal cell integrity disruption, which leads to the functional and structural failure of the pathogen's cell.

The primary biological interaction is the inhibition of the fungal enzyme Lanosterol 14-alpha-demethylase ( CYP51 A1) . This molecular action arrests a critical stage in the Ergosterol Biosynthesis Pathway. The resulting physiological effect is the impairment of the fungal cell's capacity for structural maintenance. By blocking ergosterol production and causing the accumulation of toxic intermediate sterols, the drug creates a defective and overly permeable cell membrane.

This structural failure is a crucial mechanistic step that results in the fungistatic effect (inhibition of fungal propagation) and, at sufficient concentrations, the fungicidal effect (pathogen cell lysis). The action maintains selectivity for fungal CYP51 A1 over human CYP enzymes, though its efficacy can be constrained by the pathogen's adaptation, such as the development of fungal efflux pumps.

Dosage and Administration Information

How to Use Дермазол: Official Administration Guidelines

Дермазол, which primarily contains Ketoconazole 2%, is officially designated for topical (cutaneous) use only; it is not for internal, ophthalmic, or intravaginal administration. The administration schedule and duration vary based on the dosage form and specific condition being addressed, as outlined by regulatory guidelines.


Standardized Dosing and Frequency

Dosage Form Indication (Type) Standard Frequency Treatment Duration
Cream 2% Tinea infections (e.g., ringworm) Once daily Typically 2 to 6 weeks
Shampoo 2% Seborrheic Dermatitis Twice weekly 2 to 4 weeks (Initial course)
Shampoo 2% Tinea Versicolor Once daily Up to 5 days
Foam 2% Seborrheic Dermatitis Twice daily Four weeks

Key Procedural Instructions

The application process contains specific time requirements. For the 2% shampoo, the product should be applied to the affected area, lathered, and must be left in place for 3 to 5 minutes before thorough rinsing. The foam formulation requires careful handling, as it must be dispensed onto a cool surface, like the can cap, rather than warm hands, before being gently massaged into the affected area. Certain liquid forms, such as the gel and foam, are designated as flammable and must be kept away from fire, flame, and smoking during and immediately following administration.

For chronic conditions like seborrheic dermatitis, guidelines specify a prophylaxis phase where the shampoo may be used intermittently, typically once every 1 to 2 weeks, following the initial treatment course.

Recent Clinical Evidence

Research evidence / Overview of studies for Дермазол

This overview describes the types of clinical research and studies that have been conducted on topical Ketoconazole (the active ingredient in Дермазол), detailing how the evidence was collected, what researchers measured, and where limitations or uncertainties still exist. This information is based on authoritative regulatory reviews and high-quality peer-reviewed research.


1. Evidence for use in Seborrheic Dermatitis (Scaling and Flaking)

The research base for this condition, characterized by fluctuating or episodic manifestations, was evaluated in Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews. These short-term RCTs explored how symptoms change over time and included adult and adolescent cohorts. Researchers measured outcomes like the degree of scaling, Erythema (redness), and Pruritus (itching), alongside Mycological Cure (elimination of Malassezia yeast). Studies report how symptoms evolved in the observed populations, where measurable differences in the rates of Overall Treatment Success were noted between the treatment group and the inactive vehicle group. Evidence remains limited for long-term outcomes and for maintenance treatment beyond the initial four-week assessment phase.


2. Evidence for use in Tinea Infections (Ringworm and Athlete's Foot)

The research on Tinea infections, such as Athlete's Foot (Tinea Pedis), includes Randomized, Double-Blind, Vehicle-Controlled Trials. These multi-center studies monitored outcomes related to systemic or functional imbalance caused by the infection, primarily in adult populations with uncomplicated forms. The main outcomes assessed were Mycological Cure and Clinical Cure. Studies report patterns where differences in the measured mycological and clinical cure rates were noted between the treatment and vehicle groups during the assessment periods (4 to 8 weeks). Research results apply only to the populations studied, focusing predominantly on uncomplicated interdigital Tinea Pedis.


6. Research Gaps and Areas of Uncertainty

The research contributes to the broader evidence landscape, but some key areas of uncertainty remain. One primary limitation is that follow-up durations were limited, meaning the certainty remains low regarding the long-term durability of the effects and optimal strategy for recurrence prevention. Additionally, evidence is limited regarding the use in special or more complex patient groups, such as those with underlying conditions like uncontrolled diabetes, who are typically excluded from primary clinical trials.

Key Studies & References

  1. Ketoconazole (Topical) Drug Information
  2. Ketoconazole Monograph

Frequently Asked Questions (FAQ)

Common questions about Дермазол (FAQ)


Q: Is it permissible to use Dermazol during pregnancy?

Official documents indicate that the systemic absorption of the active ingredient, ketoconazole, is minimal following topical application, and plasma concentrations are usually non-detectable. Limited data in pregnant women have not identified an increased risk, but official regulatory information indicates that the use of the drug should be discussed with a healthcare provider after evaluating the potential benefits and risks.


Q: Is Dermazol allowed for use by breastfeeding mothers?

Regulatory sources note that a very small amount, if any, of the active substance is expected to be transferred into breast milk due to minimal systemic absorption when applied topically. Its use is generally considered acceptable, but regulatory information suggests exercising precaution to avoid direct exposure of the infant to the treated area or product.


Q: When does Dermazol start to work? How long until I see an effect?

Regulatory documents describe that full treatment courses vary based on the infection, typically lasting between two to six weeks. While clinical improvement (symptom reduction) may be noticed before the end of the course, regulatory guidelines emphasize the importance of completing the full application period to ensure the complete elimination of the fungal pathogen.


Q: Can Dermazol affect hair color or texture?

Official post-marketing reports indicate that the Dermazol shampoo formulation may potentially lead to an abnormal hair texture or hair discoloration, particularly in hair that has been chemically treated or damaged. If changes in hair color or texture are observed, consulting the official prescribing information is noted as a relevant step.


Q: Are there official studies confirming the effectiveness of Dermazol?

Yes, the official approval of Dermazol is based on clinical trial data, including Randomized Controlled Trials (RCTs). These studies assessed endpoints such as mycological cure (elimination of the fungus) and clinical cure for conditions like seborrheic dermatitis, with data describing measurable differences in outcomes between the treatment group and the control group.


Q: If I stop using Dermazol, will the problem return?

For chronic conditions like seborrheic dermatitis, regulatory documents specify a prophylaxis phase, where the treatment may be continued at a reduced frequency (e.g., once every 1–2 weeks) after the initial course. Regulatory documents note that the issue may recur if prophylactic measures are not followed after the initial treatment course.


Q: Can Dermazol be used for the prevention of fungal infections?

Yes, official product instructions for Dermazol shampoo specifically list a prophylactic use regimen for preventing the recurrence of seborrheic dermatitis. This maintenance phase typically involves less frequent application following the successful completion of the initial treatment course.


Q: Can I apply Dermazol to open wounds or broken skin?

Instructions for over-the-counter use generally advise against applying the product to skin that is inflamed, irritated, or broken. Official guidelines indicate that application to damaged or compromised skin should be discussed with a healthcare professional.


Q: What are the available forms of Dermazol?

Regulatory documents confirm that Dermazol, which contains ketoconazole, is available in several topical formulations, including a 2% cream, a 2% shampoo, a 2% gel, and a 2% foam. These different forms are often approved for treating specific types of fungal skin conditions.


Q: How does Dermazol differ from other dandruff shampoos?

Official documents classify Dermazol (ketoconazole) as an antifungal agent. Its mechanism of action is distinct from many cosmetic or bacterial-targeting shampoos because it specifically works to suppress the growth of the Malassezia yeast, which is a primary cause of seborrheic dermatitis and dandruff.


Q: What should I do if Dermazol gets into my eyes?

In case of accidental exposure to the eyes, official safety sheets describe the procedure of immediately rinsing the affected eye(s) thoroughly with water. If irritation or redness persists after rinsing, it is noted that seeking medical attention may be necessary.


Q: Do I need a doctor's prescription to buy Dermazol?

Many topical forms of Dermazol containing 2% ketoconazole are officially available for purchase without a prescription (Over-The-Counter). However, some prescription-only strengths or forms may exist, and consulting a healthcare professional is always part of appropriate medical care for diagnosis.


Q: What should I do if I miss an application of Dermazol?

Official administration guidance generally recommends that if an application is missed, the dose should be skipped, and the patient should return to the regular dosing schedule. It is noted that the dose should not be doubled to compensate for the missed application.


Q: Can I use Dermazol if I have sensitive skin?

Official labeling notes that Dermazol can cause local skin reactions, such as application site irritation, burning sensation, or contact dermatitis. The regulatory warnings indicate that application should be stopped if severe or persistent irritation occurs.


Q: Can Dermazol help treat nail fungus (onychomycosis)?

Clinical guidelines and official product indications typically do not list topical ketoconazole as the primary standalone treatment for nail fungus (onychomycosis). This is often due to challenges with drug penetration, and systemic (oral) medications are generally regarded as more appropriate for this specific condition.


Q: Does Dermazol treat only the symptoms or the underlying cause of the disease?

Dermazol treats the underlying cause of the condition. Its active substance, ketoconazole, is an antifungal agent that works by disrupting the cell membrane structure of fungal organisms, thereby suppressing their growth and replication.


Q: Is it possible to be allergic to Dermazol?

Yes, hypersensitivity (allergy) to ketoconazole or any component of the formulation is listed in official documents as an absolute contraindication for use. Reports of severe allergic reactions like urticaria (hives) and angioedema have been reported as adverse effects with an unknown frequency.


Q: Is there official information about overdosing on topical Dermazol?

Official information regarding overdose mainly addresses the risks of accidental internal ingestion. For topical use, excessive application may lead to localized effects like redness or irritation of the skin, in which case reducing the frequency of application may be suggested.


Q: Is Dermazol approved for long-term use?

Regulatory documents establish specific durations for initial treatment (e.g., up to 4–6 weeks) and for prophylaxis (e.g., once every 1–2 weeks). Continuous, extended daily use that exceeds the specified periods without professional medical evaluation is not generally noted in the official labeling.


Q: Does Dermazol affect my ability to drive or operate machinery?

In connection with the minimal systemic absorption of the active ingredient when applied topically, official documents do not contain any warnings indicating that Dermazol affects a patient’s ability to drive a vehicle or operate heavy machinery.


Q: Does Dermazol contain any known allergens?

Some formulations of Dermazol may contain excipients like cetyl or stearyl alcohols, which are noted to potentially cause localized skin reactions. Certain formulas may also contain sulfites. The full list of all components should be consulted in the official package insert for the specific product being used.


Q: Is there information in the official documentation about Dermazol interacting with alcohol?

Official documents for topical Dermazol confirm that there are no clinically significant interactions documented with alcohol. This is attributed to the negligible amount of the active substance that is absorbed into the bloodstream from topical application.


Q: What is known about fungal resistance to Dermazol?

Official pharmacological reviews acknowledge that resistance to ketoconazole has been reported in certain fungal species. Since it belongs to the azole class of antifungals, cross-resistance among drugs within this class can sometimes be observed.


Q: What should I do if I experience severe burning after applying Dermazol?

Severe burning is a documented local adverse reaction. Official warnings describe this as a local adverse reaction and indicate that use should be stopped and a healthcare professional should be contacted if the reaction is severe or persistent.


Q: Does Dermazol contain parabens or sulfates?

Some formulations of Dermazol may contain sulfites, which are noted in the official precautions due to the potential for allergic reactions in some individuals. The presence of other specific excipients, such as parabens, requires checking the complete list of inactive ingredients for the particular product form.


Q: Why does Dermazol sometimes not help treat a fungal infection?

Official documents note that a lack of improvement or worsening of the condition may be related to factors like an incorrect diagnosis or fungal resistance, which typically requires re-evaluation by a healthcare provider.


Q: Does Dermazol contain hormones?

No, Dermazol (ketoconazole) belongs to the antifungal class of medicines (imidazole antifungals) and is not a corticosteroid or other type of hormone. However, official warnings caution against applying it immediately after or in combination with potent topical corticosteroids.


Q: How can I tell that the fungal infection is completely cured by Dermazol?

Clinical trials use endpoints like 'Clinical Cure' (disappearance of visible symptoms) and 'Mycological Cure' (laboratory confirmation of fungal elimination). For a patient, the main indicator is the complete resolution of all symptoms, but regulatory guidelines emphasize the importance of completing the full application course, even if symptoms appear to clear early.


Q: Is there a difference in action between the Dermazol cream and shampoo?

Although the active ingredient is the same, official documents specify different indications and dosing regimens for the cream and shampoo formulations. For example, the shampoo is primarily indicated for seborrheic dermatitis, while the cream is generally indicated for tinea infections on the skin surface.


Q: For what other conditions, besides dandruff, is Dermazol used?

In addition to dandruff (often a symptom of seborrheic dermatitis), the officially approved indications for Dermazol include the treatment of ringworm (tinea corporis), jock itch (tinea cruris), athlete's foot (tinea pedis), and tinea versicolor (pityriasis versicolor).


Q: What do official sources say about using Dermazol in hot climates?

Official storage instructions require the product to be kept at controlled room temperature (typically 20 - 25 C) and protected from excessive heat and moisture to maintain product integrity. These requirements relate to storage conditions and do not provide specific application advice for use in high-temperature environments.

How should Дермазол be stored and disposed of?

The storage and disposal of Дермазол (Ketoconazole topical products) must adhere strictly to the conditions specified in official regulatory labeling to ensure product integrity and public safety.

Storage Requirements

Item Official Regulatory Requirement
Temperature Store at Controlled Room Temperature, typically 20^circ to 25 C (68^circ to 77 F). Do not store above 25 C (77 F) or freeze the product.
Environmental Protection The product must be protected from light and kept away from excessive heat and moisture.
Container Rules Keep the medicine in its original container and ensure the container is tightly closed when not in use.
Child Protection Must be stored out of the reach and sight of children.

Disposal Instructions

Any unused, unwanted, or expired portions of the medicine must be disposed of according to local regulations for pharmaceutical waste. Do not dispose of the product by flushing it down a toilet or pouring it into a drain unless specific instructions authorize this.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Дермазол found in:

A-Z Index: