Cloderm

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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 Cloderm

What is Cloderm?

Cloderm is a topical corticosteroid medication containing the active ingredient clocortolone pivalate. It is formulated as a cream and is classified as a medium-potency, or Group 4, corticosteroid. This medication is primarily used for the management of various skin conditions characterized by inflammation and itching.

Mechanism of Action

Clocortolone pivalate works by interacting with intracellular glucocorticoid receptors. Once bound, the medication helps to stabilize cellular membranes and reduce the release of inflammatory mediators. This process leads to several physiological effects at the site of application:

  • Anti-inflammatory: It reduces the redness, swelling, and warmth associated with skin irritation.
  • Antipruritic: It helps alleviate the sensation of itching.
  • Vasoconstrictive: It causes the constriction of blood vessels in the skin, which further aids in reducing redness and edema.

Clinical Applications

Cloderm is typically used to treat corticosteroid-responsive dermatoses. These conditions involve an overactive immune response in the skin and may include:

  • Atopic Dermatitis: A chronic condition that causes itchy, inflamed skin.
  • Contact Dermatitis: Skin reactions resulting from contact with specific allergens or irritants.
  • Psoriasis: An autoimmune condition that leads to the rapid buildup of skin cells, often appearing as plaques.
  • Seborrheic Dermatitis: A common skin condition that mainly affects the scalp, causing scaly patches and red skin.

Unlike lower-potency steroids, Cloderm is designed to provide effective relief for moderate inflammatory symptoms while maintaining a profile suitable for various areas of the body.

Regulatory References

  1. WHO Essential Medicines List
  2. WHO Model List of Essential Medicines
  3. NIH MedlinePlus Drug Information on Clotrimazole Topical

What side effects are possible with Cloderm?

Possible Side Effects and Safety Information

The safety profile of Clotrimazole topical preparations is predominantly characterized by localized reactions at the application site, consistent with its minimal systemic absorption. Official regulatory documents classify potential adverse reactions into specific frequency and organ-system categories.


Adverse Reaction Classification

Category Documented Reactions and Safety Notes
Common Side Effects Localized skin irritation, burning sensation, stinging, pruritus (itching), and redness (erythema).
Serious Adverse Reactions Rare but significant immune system disorders are documented, including Anaphylactic reactions, Angioedema, and generalized Hypersensitivity reactions, which may be accompanied by symptoms like hypotension or syncope.
System-Organ Classes Adverse events primarily relate to Skin and subcutaneous tissue disorders and Immune system disorders, according to regulatory classifications.

Safety Restrictions and Considerations

Clotrimazole topical is officially contraindicated in individuals with known hypersensitivity to the active substance or any non-active ingredient in the formulation. The product is intended strictly for topical use and must not be used in the eyes or taken orally.

Regulatory labeling also includes specific safety considerations for patient groups. Use during the first trimester of pregnancy is limited to when clearly indicated. When used in the genital area, the medicine may temporarily interfere with and compromise the integrity of latex-based barrier contraceptive products, such as condoms and diaphragms, reducing their effectiveness.

Overdose and Emergency Response

Overdose Scope

Category Official Regulatory Statement
Documented Overdose Presentations No specific systemic symptoms of acute overdosage from topical application are documented in the prescribing information.
Physiological Systems Affected No specific physiological systems are listed as being adversely affected by topical overdosage, as systemic absorption is minimal.
Dose-related or exposure-related factors The primary trigger for mandated emergency action is the accidental ingestion of the product.
Population-specific overdose notes No specific population-based considerations regarding overdose severity are documented in the official overdose sections.
Emergency-response statements In the case of accidental ingestion, the required emergency action is to seek professional assistance or contact a Poison Control Center right away.
When immediate medical help is required Immediate medical help is required when accidental ingestion of the product occurs.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement (or Absence Thereof)
Severity classification Acute overdosage with topical application would not be expected to lead to a life-threatening situation.
Regulatory basis The basis is the low systemic exposure profile of the drug's formulation for its intended route of administration.
Overdose-context constraints The concern is limited to acute overdosage with accidental ingestion; over-application is unlikely to result in toxicity.

Resulting Overdose Structure

Official Overdose Statements:

  • Acute overdosage resulting from the intended topical application of Clotrimazole is unlikely.
  • Topical overdosage is not expected to lead to a life-threatening situation.
  • In the event of accidental ingestion of the product, immediate professional assistance must be sought, or a Poison Control Center must be contacted.
  • No specific antidote is listed in the official regulatory documentation.

Connection to the overall overdose profile (2–4 sentences): The regulatory documents define the overdose profile by establishing that the risk of acute systemic toxicity from the intended topical use is low. This low risk is the basis for the regulatory statement that a life-threatening outcome from over-application is not expected. Consequently, the official emergency-seeking condition is explicitly tied to the scenario of accidental ingestion, which requires immediate contact with emergency services or a Poison Control Center.

Therapeutic Uses of Cloderm

What Cloderm Treats: Main Uses and Benefits

The medicine is commonly used across skin conditions presenting with localized discomfort, such as atopic dermatitis, seborrheic dermatitis, and psoriasis. The medication is also relevant in managing conditions involving episodic or fluctuating manifestations of skin inflammation. The application is used for managing symptom clusters that involve scaling, peeling, and redness of the skin. This supportive assistance contributes to improved comfort during symptomatic periods.


Quick Fact: Relief for Itching and Burning

  • The medicine is relevant for easing symptoms that create noticeable physiological strain, primarily intense localized itching (pruritus) and the burning sensation.

“The therapeutic purpose plays a role in managing symptoms that are related to inflammatory or irritative states, particularly the acute discomfort associated with these common dermatological conditions.”

Regulatory References

  1. NIH MedlinePlus overview of Clotrimazole Topical

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Cloderm — Official Regulatory Information

Eligibility scope Populations for whom use is allowed (as stated in label): Adults and the elderly for cutaneous and mucosal application. Pediatric patients for use as indicated. Populations for whom use is not recommended (if applicable): Children under two years of age for cutaneous use, unless directed by a doctor. Populations for whom use is contraindicated: Individuals with known hypersensitivity to Clotrimazole or any non-medicinal components in the product.

Age-related eligibility rules: Safety and effectiveness for vaginal use have not been established in pediatric patients less than 12 years of age. Older adults are not expected to require different restrictions than younger adults.

Pregnancy and lactation eligibility status (if explicitly documented): During the first trimester of pregnancy, use is permitted only if clearly indicated by a healthcare provider. Caution should be exercised when used by nursing mothers, as it is unknown whether the drug is excreted in human milk.

Eligibility-related restrictions: Cloderm is not for ophthalmic use (eyes) and is documented as not effective for the treatment of nail or scalp infections.

Eligibility classifications (high-level) Eligibility severity classification (as defined in official documents): Contraindicated (Absolute prohibition), Use with Caution (Conditional restriction), and Safety and Effectiveness Not Established (Insufficient data).

Connection to the overall eligibility profile (2–4 sentences): Regulatory documents define eligibility through absolute contraindications for allergic individuals and by setting explicit restrictions based on age and reproductive status. The profile further mandates that the medicine not be applied to specific anatomical sites or used for conditions where efficacy is unestablished, establishing clear boundaries for permissible use.

What should I know about interactions with other medicines?

Cloderm (clocortolone pivalate) is a topical corticosteroid and, when used as directed, the amount of medicine absorbed into the bloodstream is generally low. Due to this low systemic absorption, the potential for drug-drug interactions with orally taken or injectable medications is considered minimal.

However, it is always important to inform your healthcare provider about all medications you are currently using, including prescription and over-the-counter drugs, vitamins, herbal products, and other topical treatments. This includes:

  • Other Corticosteroid Products: The concurrent use of Cloderm with other topical or systemic corticosteroids (such as oral prednisone or other steroid creams) may increase the risk of systemic side effects. These effects are related to excess steroid exposure, such as Hypothalamic-Pituitary-Adrenal (HPA) axis suppression.
  • Topical Products: Avoid using other creams, lotions, or cosmetics on the same treated area without consulting your doctor, as this could potentially alter Cloderm's absorption or effectiveness, or increase skin irritation.

Potential Systemic Concerns

Although rare with proper topical use, if significant amounts of Cloderm are absorbed, there is a theoretical risk of interactions common to systemic corticosteroids. These can include:

Interacting Drug Class Potential Effect
Antidiabetic Agents (e.g., insulin, metformin) Corticosteroids may increase blood sugar (glucose) levels, potentially requiring dose adjustments for diabetic patients.
Cyclosporine May increase the concentration and risk of side effects for both Clocortolone and Cyclosporine.

Always discuss your complete medical history, especially conditions like diabetes or adrenal gland disorders, with your healthcare professional before starting Cloderm, as these conditions can be affected by the use of corticosteroids.

Mechanism of Action

Molecular Targeting and Ergosterol Pathway Disruption

The primary mechanism involves the targeted inhibition of lanosterol 14-alpha-demethylase (CYP51), an enzyme exclusive to fungal cells. Cloderm binds to the enzyme's active site, halting a critical step in the ergosterol biosynthesis pathway. This action immediately prevents the fungal cell from producing the essential sterol component required for its protective cell membrane, a process which initiates structural and functional impairment of the cell.

Inducing Fungal Cell Permeability and Lysis

Blocking ergosterol production leads to the harmful accumulation of structurally defective 14-alpha-methylated sterol intermediates within the fungal cell membrane. The combined effect of structural instability and toxic accumulation compromises the membrane's integrity, causing it to become uncontrollably permeable. This physiological failure results in the rapid leakage of vital intracellular material, ultimately leading to fungal cell death (lysis) at sufficient concentrations.

Mechanistic Boundaries and Constraints

The drug's activity is confined to fungal cells at the site of application (local action) and acts primarily on actively growing and metabolizing organisms. Its effectiveness is physiologically constrained by the inability to penetrate dense structures like the nail plate and exhibits reduced activity against non-proliferating forms such as spores.

Dosage and Administration Information

How Cloderm is Used

Cloderm is administered via the topical route. The frequency of application is dictated by the specific clinical presentation and the standards established in the product labeling. The usage protocols follow regimens designed to manage inflammatory skin conditions.


Administration Route and Standard Schedule

Administration Route Frequency Patterns Standard Labeled Dosing Principles
Topical (Cream) Generally applied three times daily. Apply a thin layer to the affected area and massage gently.

Key Procedural Guidelines

Prior to topical application, the affected skin area should be washed and thoroughly dried. The product is intended for external use and is applied to the skin as directed by established clinical standards. If a dose is missed, it is typically applied as soon as it is remembered, unless it is nearly time for the next scheduled application, in which case the regular schedule is resumed. This usage structure is designed to ensure the medication is delivered consistently over the course of treatment.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Cloderm (clocortolone pivalate 0.1% cream) is a mid-potency topical corticosteroid (Class IV) indicated for the relief of inflammatory and itching manifestations of corticosteroid-responsive dermatoses, such as eczema, atopic dermatitis, contact dermatitis, and psoriasis. Clinical trials have focused on characterizing its effects and safety profile across various patient populations.


Efficacy and Onset of Observation

Research has explored the association between treatment with clocortolone pivalate 0.1% cream and changes in the signs and symptoms of inflammatory skin conditions. Randomized controlled trials (RCTs) demonstrated that the product performed statistically better than its vehicle (the cream base without the active drug) in treating conditions like eczema and atopic dermatitis. Specifically, statistically significant differences relative to the vehicle were observed as early as Day 4 in studies involving patients with eczema and atopic dermatitis.

In trials studying psoriasis, the formulation demonstrated differences relative to the vehicle by Day 7 of application, with these observations continuing through the 28-day study period. Furthermore, studies have suggested that the unique formulation may enhance skin barrier function by providing increased hydration compared to some other formulations.


Safety and Tolerability Findings

In clinical trials involving over 2,500 adult and pediatric patients with corticosteroid-responsive skin conditions, clocortolone pivalate 0.1% cream reported a favorable safety profile. The most common adverse events observed were mild local reactions at the application site.

Studies also investigated the potential for systemic effects, specifically the hypothalamic-pituitary-adrenal (HPA) axis suppression, which can occur with potent topical corticosteroids. In a key 21-day study, no evidence of HPA axis suppression was found in healthy adult subjects who applied large amounts of the cream daily under occlusive conditions.

Frequently Asked Questions (FAQ)

Common questions about Cloderm (FAQ)

Q: How quickly does Cloderm usually start to relieve itching?

Studies included in the official product information indicate a rapid onset of action. For inflammatory conditions like atopic dermatitis, statistically significant overall improvement compared to the cream base has been observed as early as Day 4 of treatment, which suggests an onset of action for overall signs and symptoms, including those related to itching, may be observed early in the treatment course.

Q: Are there any common over-the-counter products that interact with Cloderm?

Official product information advises against applying other creams, lotions, or cosmetics to the treated area unless specifically instructed by a healthcare provider. These products could potentially change how the medication is absorbed or affect its effectiveness.

Q: Is it safe to use Cloderm on the face or sensitive areas?

Official product information states that topical corticosteroids, including Cloderm, should generally not be used on the face, underarms (armpits), or groin area. The drug is for external use only, and contact with the eyes should be avoided. The use of this medication on sensitive or thin-skinned areas is generally restricted and should be discussed with a healthcare provider.

Q: What are the most common side effects people report after using Cloderm?

According to the official adverse reactions information, the most common side effects reported are reactions that occur directly at the application site. These include a sensation of burning, itching (pruritus), stinging, and general skin irritation.

Q: What happens if I accidentally use more Cloderm than directed?

Using more than the recommended amount, covering a large area of skin, or using the cream for prolonged periods can potentially increase the amount of medicine absorbed into the body. This increased systemic absorption could lead to systemic side effects, such as reversible suppression of the HPA axis (a hormone regulatory system).

Q: Is it normal to feel a slight stinging sensation when first applying Cloderm?

Official safety information lists stinging and burning as common local adverse reactions. These sensations may be experienced when the medication is first applied to the skin.

Q: Can using a moisturizer with Cloderm make it work better?

Official patient information advises caution regarding the use of other topical creams, lotions, or cosmetics on the treated area unless directed by a healthcare provider. These products could potentially alter the skin’s absorption of Cloderm, which may affect its effectiveness.

Q: What should I do if my skin irritation seems worse after using Cloderm?

Regulatory guidance advises that if irritation or signs of hypersensitivity (allergic reaction) develop or worsen, it is a signal to stop using the product and contact a healthcare professional to determine the next steps.

Q: How does the steroid in Cloderm actually reduce inflammation?

Clocortolone Pivalate is classified as a topical corticosteroid with properties that help reduce inflammation, itching (antipruritic effect), and promote the constriction of blood vessels (vasoconstrictive effect). While the full cellular mechanism is complex, this action is how the medicine works to relieve symptoms like redness and swelling in the skin.

Q: How does stopping Cloderm treatment affect the skin condition?

Official documentation notes that in some cases, patients may experience signs and symptoms of steroid withdrawal after discontinuing the drug. The way treatment is discontinued, such as tapering, is a clinical decision. In some cases, patients may require a gradual withdrawal to prevent the occurrence of steroid withdrawal symptoms.

Q: Can Cloderm cause a rebound effect if I stop using it suddenly?

Abrupt discontinuation of the drug, particularly after long-term use, has been associated with signs of steroid withdrawal. These effects may include the underlying skin condition recurring or appearing to worsen, which is sometimes referred to as a rebound effect.

Q: What should I look for to know Cloderm is starting to work?

The official indication for Cloderm is to relieve the signs and symptoms of inflammation and itching associated with certain skin conditions. Improvement in symptoms such as a reduction in visible redness, swelling, and the severity of itching in the treated area suggests that the medication is having its intended effect.

Q: Does Cloderm help with fungal infections, or just inflammation?

Cloderm (Clocortolone Pivalate) is a topical corticosteroid that is officially indicated for the relief of inflammatory and pruritic (itching) skin issues. It is not indicated or approved as an antifungal agent to treat fungal infections.

Q: What research studies support the effectiveness of Cloderm for dermatitis?

The FDA label and related official documents contain summarized data from controlled clinical trials, including randomized controlled trials (RCTs). These studies have shown the drug's effectiveness and safety profile compared to the cream vehicle (placebo) in treating specific conditions like atopic dermatitis and eczema.

Q: Can Cloderm make skin appear lighter or darker after use?

Official adverse reaction reports for topical corticosteroids include changes in skin pigmentation. This may involve the lightening of the normal skin color in the treated area.

Q: Does using an occlusive dressing (like a bandage) with Cloderm change its effect?

Official patient information cautions against covering or wrapping the treated skin area with an occlusive dressing (such as a bandage or plastic wrap). This practice can significantly increase the amount of medicine absorbed through the skin and elevate the risk of experiencing systemic side effects. The use of occlusive dressings is a decision that should be made by a healthcare professional.

How should Cloderm be stored and disposed of?

How to Store and Dispose of Cloderm (Clocortolone Pivalate)

Cloderm cream must be stored at Controlled Room Temperature, specifically between 20 and 25 C (68 and 77 F). The medication should be protected from extreme conditions, and it is mandatory to avoid freezing. For stability, the container must be kept tightly closed and stored away from excess heat and moisture.

Regulatory labeling requires a prominent warning to KEEP OUT OF REACH OF CHILDREN. Official disposal instructions for this topical product advise following general guidelines, such as utilizing a drug take-back program or disposing of the unused product in the household trash according to federal guidelines when a take-back option is unavailable.

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

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