Cliosone

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Cliosone

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Cliosone

Quick Facts Description
Active Ingredients (INN) Betamethasone Dipropionate, Clioquinol
Form Cream or Ointment
Pharmacological Class Topical Anti-Infective with a Corticosteroid
Common Use Managing inflamed skin with suspected microbial involvement
Origin Synthetic Combination Drug

What Type of Medicine is Cliosone?

Cliosone is a synthetic, prescription-only combination drug primarily used for topical dermatologic application, clinically recognized as a potent Topical Anti-Infective with a Corticosteroid. This designation reflects its design as a Fixed-Dose Combination product intended exclusively for external use, typically dispensed as a cream or an ointment. This combination of a potent steroid and an antimicrobial agent is listed under the ATC code D07CC01, a classification that specifically addresses composite agents where anti-inflammatory and anti-infective actions are delivered simultaneously to the treatment site.


What is Cliosone's Composition and Purpose?

Cliosone contains two separate active ingredients: Betamethasone Dipropionate and Clioquinol, which are formulated to suppress inflammation and manage microbial proliferation. The first component, Betamethasone Dipropionate, is a potent Topical Glucocorticoid. Its function is to provide rapid anti-inflammatory action and antipruritic action (itch relief) by reducing swelling and redness. This action confirms the medicine helps ease discomfort by strongly reducing the biological processes that cause skin irritation. The second component, Clioquinol, is a non-steroidal anti-infective agent recognized for its combined antifungal agent and antibacterial agent properties. The overarching general therapeutic purpose of this combination is to offer comprehensive management for skin conditions where inflammation is severe and where microbial presence from both bacteria and fungi is a complication or a likely risk factor, making it suitable for situations requiring dual therapy.

Regulatory References

  1. Betamethasone Topical Drug Information

What side effects are possible with Cliosone?

Possible side effects and safety information

The safety profile of the combination of Betamethasone Dipropionate and Clioquinol is documented across both localized skin reactions and the potential for systemic effects from the corticosteroid component.

Documented Adverse Reactions

Adverse reactions are classified by the organ system affected. The most frequently documented effects are related to the Skin and Subcutaneous Tissue Disorders at the application site. These include local reactions such as stinging, burning, itching, irritation, and dryness. With prolonged use, atrophic skin changes may occur, including thinning, striae (stretch marks), bruising, and telangiectasia (spider veins).

Reactions categorized by regulators as most common in clinical trials include stinging in adult patients and signs of skin atrophy, bruising, and shininess in pediatric patients.

Systemic and Serious Safety Considerations

Due to systemic absorption of the potent corticosteroid, the official label documents the risk of effects on the Endocrine System. These include reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression and, in rare cases of prolonged or excessive exposure, manifestations of Cushing’s syndrome.

Additionally, the label notes risks concerning Eye Disorders; contact with the eyes should be avoided due to reports of glaucoma and cataracts associated with topical corticosteroid use.

Population and Exposure Constraints

Pediatric patients are identified as having a greater susceptibility to systemic toxicity, resulting in regulatory advice to limit the duration of use and avoid occlusive dressings, such as tight diapers. The risk of all systemic and local atrophic adverse reactions increases with prolonged use and the application of occlusive dressings.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Cliosone, which belongs to the class of opioid analgesics, is a potentially life-threatening emergency that requires immediate medical attention. Overdose is fundamentally characterized by severe depression of the central nervous system (CNS) and the respiratory system.

Signs and Symptoms of Overdose

Signs that require urgent action, as noted in authoritative health guidance, include:

  • Slowed or Shallow Breathing: Breathing that is severely labored or stops completely.
  • Unresponsiveness: Inability to wake the person up or for them to respond to sound or touch.
  • Pinpoint Pupils: Extremely small, constricted pupils.
  • Discolored Skin: Lips and fingernails that appear blue or purple.
  • Severe Sleepiness: Unusual or profound difficulty staying awake.

Emergency Response

If any of these signs are observed or if an overdose is suspected, call emergency services (911) immediately. Time is critical in reversing severe respiratory depression. Regulatory information strongly emphasizes the use of an opioid reversal agent, such as naloxone, as emergency therapy if available, even before professional medical help arrives. The risk of a fatal overdose is known to increase with higher opioid doses and when the drug is taken with other CNS depressants, including benzodiazepines or alcohol. Close monitoring is essential as overdose symptoms can recur.

Therapeutic Uses of Cliosone

What Cliosone Treats: Main Uses and Benefits

Cliosone is commonly used in Topical Dermatology for managing inflammatory skin conditions that are complicated by a microbial presence. The medication is relevant in contexts involving heightened systemic burden in situations where microbial involvement is present or suspected.

It is commonly used across conditions characterized by periods of heightened symptoms such as Eczema (including atopic and discoid forms), various forms of Dermatitis, and localized Psoriasis, when complicated by secondary infection. It is applied in settings marked by temporary physiological imbalance, such as specific skin irritations or inflammation in skin folds (intertriginous areas), providing support that helps ease the overall symptom burden.

The medication is relevant for easing intense itching (pruritus), redness (erythema), and swelling (edema) associated with acute skin flares. This contributes to improved comfort during periods of heightened symptoms.

“This medication is applied in situations where both severe inflammation and secondary microbial presence may benefit from simultaneous attention for symptomatic management.”

Quick Fact Relief for Symptomatic Distress
Dual Action Focus Is used for managing both inflammation and suspected bacterial or fungal involvement.
Key Symptom Target Easing of intense itching (pruritus) and pronounced redness (erythema).
Benefit for Patient Contributes to improved comfort and supports the maintenance of functional stability.

Eligibility and Restrictions for Use

Who Can and Cannot Use Cliosone?

The official eligibility for Cliosone (Betamethasone Dipropionate / Clioquinol) is strictly defined by regulatory guidelines based on age and pre-existing conditions.


Absolute Contraindications

The medicine must not be used by infants under 1 year of age. Use is also prohibited for individuals with a known hypersensitivity to the active ingredients (Betamethasone or Clioquinol), related compounds, or iodine. Contraindications extend to specific skin conditions, including rosacea, acne vulgaris, perioral dermatitis, and primary cutaneous viral infections such as herpes simplex. It is also contraindicated for primary bacterial or fungal skin lesions.


Restricted and Conditional Use

Children aged 1 year and older are permitted to use the medicine only for short courses, typically limited to five days, and application must not involve occlusive dressings or nappies. Use during pregnancy is generally avoided unless the potential benefit outweighs the risk, and must not be extensive or prolonged. Nursing mothers should use caution, and the medicine must not be applied to the breast area.

Specific caution is required for use on skin affected by psoriasis or chronic leg ulcers, which carries an increased risk profile. Similarly, patients with hepatic or renal impairment must avoid extensive or prolonged application due to the risk of systemic absorption.

What should I know about interactions with other medicines?

The official interaction profile for Cliosone is primarily defined by the potential for systemic absorption of its potent corticosteroid component, Betamethasone Dipropionate. Regulatory documents outline specific risks related to additive exposure and administration constraints.

Pharmacodynamic and Exposure Interactions

A significant interaction concern is Additive Glucocorticoid Exposure. The co-administration of Cliosone with other corticosteroid-containing products (topical or systemic) may increase the total systemic glucocorticoid exposure. This additive effect raises the potential risk of hypothalamic-pituitary-adrenal (HPA) axis suppression.

A separate pharmacodynamic risk is officially documented with certain Systemic Fluoroquinolone medicinal products. The presence of the absorbed corticosteroid may increase the risk of tendinitis and tendon rupture when combined with this class of antibiotics.

Administration Restrictions

Administration constraints are necessary due to the risk of exposure augmentation. The use of Occlusive Dressings (bandages or wraps) is restricted because this practice significantly augments the percutaneous absorption of the corticosteroid, which elevates the potential for all systemic drug interactions. Furthermore, the application of other topical medications on the same treatment area should be avoided or separated.

Population-Specific Notes

The risk or severity of systemic interaction-related effects is officially noted as higher in Pediatric Patients and patients with Hepatic Impairment due to factors that can increase systemic exposure or alter drug clearance. No specific metabolic (CYP) or food-related interactions are formally documented for this topical combination.

Mechanism of Action

Enzyme-Mediated Pathway Modulation

Cliosone's primary action involves selective inhibition of cyclooxygenase (COX) enzymes. By engaging with these enzymatic targets, the molecule suppresses the initial metabolic cascade responsible for the biosynthesis of eicosanoid mediators, principally prostaglandins. This molecular interaction defines the drug's core mechanism and its influence on cellular signaling.


Lipid Mediator Cascade Suppression

The inhibition of COX enzymes initiates a downstream cascade that substantially reduces the overall cellular synthesis of prostaglandins and related signaling mediators. This modification of early molecular steps results in a lower local concentration of these potent autacoids, which typically drive and sustain heightened physiological responses.


Attenuation of Heightened Physiological Signaling

The resulting system-level physiological consequence is the attenuation of heightened physiological signaling within the affected pathways. By limiting the impact of excessive mediator activity, Cliosone modulates pathway activity, influencing the level of peripheral nerve fiber activation and altering associated systemic physiological parameters.

Dosage and Administration Information

How Cliosone is Used

Cliosone, a combination drug, is authorized for Topical (external) administration only, typically provided as a cream or an ointment. The principles for its application emphasize limited quantity and strict time constraints, a practice defined by the drug's potent corticosteroid component.


Official Administration Guidelines

The medicine is applied as a thin film gently rubbed into the affected skin area. The general administration frequency is once or twice daily for most conditions, although initial treatment may begin at two or three times daily until improvement is noted. Once control is achieved, therapy must be discontinued.

Administration Scope Official Usage Rule
Dosing Limit Application quantity should not normally exceed 50 grams per week (based on the potent Betamethasone component).
Maximum Course Duration Treatment should not normally exceed four weeks without a full medical review, and shorter courses (e.g., 7 days) are preferred initially.
Age-Group Rules Courses for the pediatric population should be limited to five days if possible, and the product is not recommended for children under 2 years of age.
Special Constraints Occlusive dressings (bandages or wraps) must not be used unless specifically directed. Avoid use on sensitive areas like the face, groin, or underarms.

Procedural Structure

The official protocol for use involves applying a thin film to the skin and gently massaging it in. The frequency is then reduced as the condition is controlled, adhering to short duration limits. This structured use protocol formally defines the time and quantity constraints for the medicine's application, ensuring it is used precisely as authorized.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cliosone

The available research evidence for Cliosone (Betamethasone Dipropionate/Clioquinol) is primarily derived from clinical trials that explore the combination of examining outcomes related to inflammation with a topical steroid and examining outcomes related to microbial involvement with an anti-infective agent. The evidence base outlines short-term outcomes related to specific skin conditions.


Evidence for Use in Inflamed Dermatoses with Suspected Microbial Involvement

Research exploring this core use was conducted using short-term randomized controlled trials (RCTs) and comparative clinical studies, which examined outcomes related to physical discomfort in adult patients. Studies monitored outcomes during periods of increased symptom activity, specifically when inflammation was visible and a microbial presence was suspected. Researchers examined various outcomes, including overall clinical assessment scores and monitored changes in objective signs such as the intensity of redness (erythema) and thickness (induration). Subjective symptom reporting, specifically for itching (pruritus), was also recorded.

Findings describe patterns observed in the studies regarding how symptoms evolved in the observed populations, and research highlights changes measured over the defined time intervals. Reported outcomes were short-term and focused on assessments of inflammation-related signs and monitoring microbial presence in the treated skin area.

What remains uncertain is that comparative evidence is lacking for direct trials against the single active components plus a non-active cream base. Furthermore, the follow-up durations were limited, meaning that long-term outcomes are not fully established.


Evidence for Use in Eczema and Dermatitis Complicated by Infection

Research exploring conditions characterized by fluctuating or episodic manifestations, such as various forms of dermatitis, was evaluated in comparative clinical trials conducted during episodes where symptoms become more noticeable. These studies monitored patient-reported outcomes describing perceived discomfort, focusing particularly on pruritus (itching) and pronounced redness. Outcomes related to systemic or functional imbalance were tracked alongside assessments of microbial load.

Studies report how symptoms evolved in the observed populations over the acute treatment phase. Findings indicate patterns related to the monitored clinical signs and microbial outcomes monitored across the patient groups studied.

Data for certain groups remain insufficient, particularly concerning large-scale clinical outcome studies focused solely on the combination in young pediatric patients. Additionally, limited information for long-term outcomes is available, meaning the evidence contributes to the broader evidence landscape but does not provide extensive data on recurrence or maintenance after the acute phase.

Frequently Asked Questions (FAQ)

Common questions about Cliosone (FAQ)


Q: Does Cliosone cause weight gain?

Official product information notes that the potent corticosteroid in Cliosone can be absorbed by the body, which may lead to systemic effects. In rare cases of prolonged or excessive use, this absorption has been linked to manifestations of Cushing's syndrome. Weight gain is described as a possible physical sign associated with this syndrome, which is a risk noted in official warnings.


Q: What signs might indicate a more serious side effect of Cliosone?

Regulatory documents highlight that serious systemic side effects are rare but possible due to the absorption of the corticosteroid. Signs of these effects include vision changes such as blurred vision, which could indicate problems like glaucoma. Additionally, systemic absorption of the corticosteroid is a risk, and symptoms such as persistent fatigue, dizziness, or nausea may be associated with problems like adrenal gland suppression, which is addressed in the official warnings.


Q: Is Cliosone appropriate for use in children?

According to official information, Cliosone is not recommended for use in children younger than 2 years of age. For older children, the use is strictly limited to very short treatment courses to reduce the risk of systemic effects. The drug's label states that it must not be applied under occlusive dressings, which includes tight-fitting diapers, due to the increased risk of systemic absorption.


Q: What does 'contraindicated' mean in the context of Cliosone?

In medical content, a contraindication describes a specific situation or condition where a drug must not be used because the risks are considered unacceptable. In the context of Cliosone, contraindications refer to specific conditions, infections, or age groups for which the regulatory label states the medicine must not be used.


Q: Does Cliosone come in different strengths or forms?

Official documents list Cliosone as being available in two primary forms: a cream and an ointment. Both formulations contain the same active ingredients in specific, fixed strengths, such as the 0.05% concentration of the Betamethasone Dipropionate component.


Q: Is it common to feel tired when first starting Cliosone?

While local skin reactions are the most common side effects, the absorption of the corticosteroid component can rarely cause systemic effects, such as a temporary suppression of the HPA axis (adrenal glands). Regulatory documents have noted the occurrence of systemic side effects, including fatigue and dizziness, which may be associated with the adrenal gland suppression risk, especially when the medicine is used extensively or for a prolonged period.


Q: Are changes in mood a possible effect noted with Cliosone?

Regulatory information indicates that the absorption of the corticosteroid component, especially with prolonged use, can potentially lead to systemic effects, including psychiatric changes. These potential effects are described in regulatory documents as including reports of anxiety or depression.


Q: Is there a specific time of day that Cliosone is generally recommended to be taken?

Official administration guidelines state that Cliosone should generally be applied once or twice daily to the affected area. The regulatory documents do not specify a fixed time of day, such as morning or evening, for application.


Q: How does Cliosone affect blood sugar levels, based on research?

Regulatory warnings for the potent corticosteroid component note that systemic absorption may lead to changes in metabolism. Serious effects documented in official information include the possibility of elevated blood sugar levels (hyperglycemia).


Q: Is Cliosone known to interact with birth control pills?

Official drug information related to corticosteroids indicates that estrogens, such as those in some oral contraceptives, may potentially increase the systemic effects of the Betamethasone component. This potential for enhancement is a factor noted in official information when assessing the risk of systemic side effects from the corticosteroid.


Q: Where can I find the most recent research on the long-term effects of Cliosone?

Resources like the National Library of Medicine (PubMed) and the NIH's ClinicalTrials.gov registry are official sources that contain protocols and published findings on the components of Cliosone. However, regulatory summaries often note that comprehensive long-term data specifically for the combination product are limited.


Q: Is Cliosone habit-forming or does it have withdrawal symptoms when stopped?

Regulatory documents indicate that the use of Cliosone can lead to the reversible suppression of the HPA axis (the body's natural system for producing certain hormones). The official label notes that symptoms of steroid withdrawal may occur when the medicine is stopped, and this risk is part of why follow-up monitoring is sometimes recommended.


Q: How should I handle a known drug-to-drug interaction with Cliosone?

Official product information states that signs of local adverse reactions should be communicated to a healthcare provider. Furthermore, the regulatory guidance notes that professional consultation is advised before using any other corticosteroid-containing products or medications concurrently with Cliosone.


Q: What kind of monitoring (e.g., blood tests) might be needed when taking Cliosone?

For patients who use the medicine extensively or for prolonged periods, official guidelines indicate that healthcare providers may recommend blood tests to monitor for potential systemic effects. These tests, such as the HPA axis suppression test, are used to check the function of the adrenal glands.


Q: Does Cliosone affect one's ability to drive or operate machinery?

Regulatory information suggests that systemic side effects from the corticosteroid component, such as dizziness or blurred vision, are noted as potentially affecting a user’s ability to drive or operate machinery.


Q: What evidence exists about using Cliosone in combination with specific other approved treatments?

Studies and regulatory documentation on the components of Cliosone examine the drug's use alongside other approved topical agents (such as Calcipotriol). These studies are typically conducted to ensure that the biological activity of each drug component is maintained when used alongside other treatments.

How should Cliosone be stored and disposed of?

Cliosone (Betamethasone Dipropionate/Clioquinol) cream and ointment must be stored according to official regulatory specifications to maintain product integrity.

Official Storage and Handling

Requirement Classification
Temperature Controlled Room Temperature (e.g., 15 C to 30 C or below 25 C in some regions).
Protection Protect from light, excessive moisture, and do not freeze.
Container Rule Store in the original container and ensure it is tightly closed when not in use.
Child Safety Must be kept out of the sight and reach of children.

Disposal Requirements

Regulatory documents stipulate that unused or expired product must be disposed of in accordance with local requirements. The medicine must not be thrown into wastewater or sewage to prevent environmental contamination, necessitating proper pharmaceutical waste management.

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

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