Afloderm

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Afloderm

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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 Afloderm

Quick Facts

Property Description
Active Ingredient Alclometasone dipropionate
Form Cream and Ointment
Pharmacological Class Topical Corticosteroid / Glucocorticoid
Common Use Reducing skin inflammation and itching
Origin Synthetic steroid (prednisolone derivative)

What is Afloderm and its Active Ingredient?

Afloderm is a pharmaceutical preparation intended for topical administration to the skin surface, primarily used in the management of symptoms related to skin inflammation and itching. The medication's core therapeutic action relies on the active ingredient Alclometasone dipropionate, a synthetic corticosteroid. This compound is not naturally sourced but is a chemically modified derivative of prednisolone. Afloderm is characterized as a single-ingredient product, designed for focused dermatological application across various patient groups, including pediatric patients older than one year of age.

Afloderm's Classification as a Topical Glucocorticoid

Afloderm belongs to the pharmacological class of Topical Corticosteroids, also referred to as Topical Glucocorticoids. The medication is specifically designated as a low-to-medium potency preparation. This positioning is intended to balance relief of symptoms with a profile that minimizes the need for high-strength steroids. Alclometasone dipropionate acts to reduce swelling and control irritation in the skin by acting on the biological pathways that trigger inflammation.

Available Forms and General Purpose of Afloderm

Afloderm is supplied in two essential dosage forms for external use: a Cream and an Ointment. Both preparations contain the same Alclometasone active ingredient, but they utilize different base vehicles—the Cream featuring a water-washable base, and the Ointment utilizing a heavier, occlusive, emollient base. The general purpose of applying Afloderm is to provide symptomatic control of both the visible signs of skin inflammation and the intense associated itching (antipruritic action).

What side effects are possible with Afloderm?

Possible Side Effects and Safety Information

The safety profile for Alclometasone dipropionate (Afloderm) is structured around potential local reactions and the documented risk of systemic absorption, as defined in official regulatory documents. Adverse reactions are classified by frequency, primarily affecting the skin.


Adverse Reaction Scope

Category Detail
Common Side Effects Local reactions reported most frequently include burning at the application site.
Infrequent Side Effects Less common reactions documented in regulatory sources include itching (pruritus), erythema (redness), dryness, and skin irritation.
Serious Reactions A potential but rare systemic consequence is the risk of Hypothalamic-Pituitary-Adrenal (HPA) axis suppression and manifestations of Cushing's syndrome, linked to significant absorption.

Contextual Safety Patterns

The risk of adverse reactions is explicitly tied to the duration and context of use, as documented by government health authorities. Local irreversible effects like skin atrophy and striae (stretch marks) are associated with long-term use. The potential for systemic effects is increased with application over large surface areas or use under occlusive dressings.

Population-Specific Safety

Regulatory documents include specific safety considerations for pediatric patients. Children are noted to have a higher susceptibility to systemic toxicity, including HPA axis suppression and the potential for growth retardation, due to their larger skin surface area relative to body weight.

Safety limitations restrict use in individuals with known hypersensitivity to the active ingredient, and official texts advise against use in the presence of untreated skin infections.

Overdose and Emergency Response

Overdose and When to Seek Help

The overdose profile for Afloderm is focused on the potential for systemic absorption of the topical corticosteroid, which can occur with prolonged or excessive use, application over large surface areas, or under occlusive dressings. This systemic exposure may produce reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression.

Documented Manifestations and Risk: The official labeling states that chronic, excessive use may lead to clinical features resembling Cushing’s syndrome. A more serious, infrequent outcome is glucocorticosteroid insufficiency that can manifest after the treatment is discontinued. Laboratory evaluation for HPA axis suppression may utilize tests such as the ACTH stimulation test or A.M. plasma cortisol test. There is no specific antidote listed in the official documents.

Emergency Actions: Acute overdosage from dermatologic application is considered unlikely to be life-threatening. However, for any instance of accidental ingestion, the regulatory mandate is to seek emergency medical attention or contact a Poison Help line immediately. Treatment remains symptomatic and supportive. If suppression is confirmed, management may involve gradual drug withdrawal or the use of supplemental systemic corticosteroids if insufficiency occurs. Pediatric patients are noted to be at a greater risk of systemic toxicity.

Therapeutic Uses of Afloderm

What Afloderm Treats: Main Uses and Benefits

Afloderm is a low-to-medium potency topical corticosteroid primarily used for providing focused symptomatic relief across key dermatological conditions. The medication is applied across therapeutic domains involving distressing symptoms; it is intended for use within clinical settings that involve acute or disruptive symptom patterns in corticosteroid-responsive dermatoses. The primary therapeutic goal is to moderate distressing symptoms, offering supportive assistance during episodes where symptoms intensify.

Afloderm is commonly used to help with conditions characterized by periods of heightened symptoms, including atopic dermatitis (eczema), allergic contact dermatitis, and certain mild-to-moderate psoriasis lesions. It helps address symptom clusters that may become intense or disruptive, specifically pruritus (intense itching) and local inflammation (redness and swelling). In situations where patients experience inflammatory states, this usage may assist with maintaining functional stability and supports patients during episodes of heightened discomfort. It is generally used when short-term symptomatic assistance is needed for various patient groups, including pediatric patients (aged one and older), and is used to improve comfort during symptomatic periods.


Quick Fact: Support for Symptoms of Inflammatory Skin Conditions

Afloderm is commonly used across conditions presenting with acute episodes to ease the overall symptom load, and is relevant for easing intense itching and associated redness and swelling.

Regulatory References

  1. FDA DailyMed Label for Alclometasone Dipropionate

Eligibility and Restrictions for Use

Official Regulatory Eligibility for Afloderm

The eligibility profile for Afloderm (Alclometasone dipropionate) is defined by official regulatory documents that establish specific patient populations permitted to use the medicine, as well as groups for whom use is strictly prohibited or restricted.

Age Group Official Eligibility Rule
Infants/Young Children Not recommended in pediatric patients below 1 year of age; safety and efficacy are not established [FDA Label].
Children Approved for use in pediatric patients 1 year of age or older [FDA Label].
Adults & Older Adults Approved for use in adult patients, with standard criteria applying to the elderly [UK SmPC].

Populations for whom use is Contraindicated (Must NOT Use):

The medicine is strictly contraindicated in patients with a known hypersensitivity or allergy to alclometasone dipropionate or any ingredient in the formulation. Use is also prohibited in the presence of untreated infections of the skin (bacterial, fungal, viral, or tuberculous) and on specific skin conditions, including acne vulgaris, acne rosacea, and perioral dermatoses [UK SmPC].

Pregnancy and Lactation Eligibility Status:

  • Pregnancy: The drug is classified as Pregnancy Category C (US FDA) and should be used only if the potential benefit justifies the potential risk to the fetus [FDA Label].
  • Lactation: Caution is advised when administered to a nursing woman, as it is not known if the medicine passes into human milk [FDA Label].

Key Eligibility Restrictions:

Use is restricted in the diaper area, as diapers and plastic pants act as occlusive dressings, increasing absorption. Furthermore, the safety and efficacy of use for periods longer than 3 weeks have not been established in pediatric patients [FDA Label].

What should I know about interactions with other medicines?

Interactions with other medicines and products

Afloderm (Alclometasone dipropionate) is a topical corticosteroid, and its official regulatory profile does not list an extensive range of specific drug-drug interactions. This is consistent with its low-to-medium potency classification, where minimal systemic absorption is expected when the product is used as directed.

Pharmacodynamic Interaction and Systemic Risk

The single formally documented interaction is a pharmacodynamic interaction involving the co-administration of other corticosteroid-containing products. This includes both other topical steroids and systemic (oral or injectable) steroids. Combining these products results in an additive glucocorticoid load on the body. The official outcome of this effect is an increased risk of systemic toxicity, including the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression and manifestations of Cushing syndrome.

Absence of Specific Interaction Patterns

The official prescribing information confirms the absence of specific pharmacokinetic interaction types. There are no documented interactions involving the CYP enzyme system or drug transporters. Furthermore, the regulatory labeling does not specify any interaction restrictions or effects concerning food, alcohol, herbal products, or supplements, and there are no mandatory timing rules requiring separation of administration.

Population-Specific Interaction Caution

The systemic interaction risk is formally acknowledged to be greater in pediatric patients. This increased risk is due to their higher ratio of skin surface area to body mass, which can lead to greater systemic absorption and susceptibility to cumulative glucocorticoid effects.

Mechanism of Action

The mechanism of Alclometasone dipropionate begins by binding as an agonist to the cytoplasmic Glucocorticoid Receptor (GCR) within skin cells. This interaction modulates gene expression, activating the synthesis of anti-inflammatory proteins (like lipocortins) and suppressing the transcription of pro-inflammatory mediators (cytokines and histamine). This results in the reduced proliferation and activation of key immune cells, modulating activity within peripheral immune pathways.

The newly synthesized lipocortins inhibit the enzyme Phospholipase A2 (PLA2), which is crucial for initiating eicosanoid production. By blocking this early step, the mechanism prevents the formation of both prostaglandins and leukotrienes. This enzymatic blockade prevents the chemical signaling that promotes vasodilation and tissue fluid leakage, reducing the physiological consequences of excessive mediator activity.

Furthermore, the drug directly influences the local microcirculation system. It promotes vasoconstriction in the treated area, which results in the restriction of blood influx and circulating inflammatory cells. This adjustment reduces local fluid accumulation and heat, which are physiological consequences of the immune response, and contributes to the overall anti-inflammatory physiological profile.

Dosage and Administration Information

How to Use Afloderm: Official Administration Guidelines

The administration of Afloderm (Alclometasone dipropionate) is based on established protocols regarding the method, frequency, and duration of its use. The medication is available in a 0.05% Cream and a 0.05% Ointment, both intended strictly for topical application to the skin surface.


Official Usage Parameters

Parameter Instruction
Route of Administration Topical application only; non-ophthalmic (not for use in the eyes).
Standard Dosing Schedule Apply a thin film to the affected skin area.
Frequency Applied two or three times a day.

Procedural and Duration Constraints

Standard application involves the preparation being gently massaged into the skin until the product disappears. The general use protocol specifies that treatment should be discontinued once control of the skin condition has been achieved. If no improvement is observed within a 2-week period, the diagnosis is to be reassessed.

Age-Specific Use Rules

  • Adults: Follow the standard two or three times daily frequency.
  • Pediatric Patients (1 year or older): The same frequency applies, but use is generally limited to a maximum of 3 consecutive weeks.
  • Geriatric Patients: No specific dosage adjustment is warranted.

Administration Constraints

Standard administration guidelines restrict covering the treated area with occlusive dressings (e.g., bandages or wraps) unless explicitly directed by a healthcare provider. Furthermore, the product is not to be applied in the diaper area of infants, as diapers may act as an occlusive dressing.

Recent Clinical Evidence

Afloderm: Recent Clinical Evidence

Clinical evidence for Alclometasone dipropionate is primarily structured around the study of conditions characterized by fluctuating or episodic manifestations, such as Atopic Dermatitis (Eczema) and allergic Contact Dermatitis. This evaluation was conducted through short-term Randomized Controlled Trials (RCTs) and controlled comparative studies, typically designed to monitor changes over two to three weeks.

These trials monitored specific outcomes related to physical signs like Erythema (redness), Induration (swelling or thickness), and levels of Pruritus (itching). Research was designed to examine patient-reported outcomes describing perceived discomfort. Findings describe patterns observed in the studies where symptoms were monitored for change over the short study period. The evidence contributes to the broader evidence landscape by describing symptom patterns observed during periods of increased symptom activity.

Separately, the research structure for Psoriasis Vulgaris also relies on short-term RCTs that examined symptom changes in adults with localized presentations. These studies monitored specific outcomes related to physical discomfort in psoriatic plaques, primarily evaluating the degree of Scaling, Induration, and Erythema. The evidence focused on specific populations characterized by localized and mild-to-moderate disease presentations.

The overall evidence landscape is characterized by limited follow-up durations. The primary body of research was conducted over short periods, most often lasting only two to three weeks. This means that while research highlights changes measured during the study period, long-term outcomes following extended use are not fully established. Consequently, certainty remains low regarding the long-term clinical course of conditions associated with cycles of stability and flare-ups. Research includes cohorts of Pediatric patients aged one year and older, but data for certain other groups remain insufficient.

Key Studies & References Alclometasone Dipropionate Cream and Ointment Label (DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Afloderm (FAQ)


Q: Can Afloderm be used for skin dryness or just inflammation?

Official documents describe the medication's approved use as relieving the inflammatory and itching symptoms of certain skin conditions. The Ointment form, one of the two available preparations, utilizes a heavier, emollient base. This type of formulation is often selected for its emollient properties, which may assist with skin dryness.


Q: What is the difference between Afloderm and hydrocortisone?

Both belong to the same overarching class of anti-inflammatory medications. Afloderm contains the active ingredient Alclometasone dipropionate, which is officially classified as a low-to-medium potency topical corticosteroid. Hydrocortisone, by contrast, is classified separately as a low-potency topical corticosteroid.


Q: Does Afloderm interact with any common over-the-counter creams or lotions?

Official regulatory information specifies that there are no documented interaction restrictions with non-corticosteroid over-the-counter creams, lotions, or non-prescription supplements. The only formal documented interaction is with the co-administration of other steroid-containing products, as this increases the overall steroid load on the body.


Q: Why is Afloderm sometimes prescribed with an antifungal medicine?

Official documents caution against using Afloderm on skin that has an untreated infection, which includes bacterial, viral, or fungal infections. This means that if an infection is present, a separate treatment, such as an antifungal, would typically be managed by a healthcare provider, consistent with the need to treat infections before or during use.


Q: Does using a bandage or covering the treated area affect how Afloderm works?

Regulatory instructions state that the treated area should not be covered with occlusive dressings, such as bandages or wraps. Use under occlusion is considered a risk factor for increased systemic absorption, meaning more of the medicine may enter the body than is intended.


Q: Is Afloderm known to cause withdrawal symptoms when stopped?

While not specifically listed as an adverse reaction for this medication, regulatory bodies have noted that reactions, sometimes referred to as 'topical steroid withdrawal,' may occur when discontinuing any topical steroid after periods of extended use. This is a general safety consideration associated with the entire drug class.


Q: What is the research evidence summary for Afloderm's intended uses?

Clinical evidence for Afloderm is based on short-term Randomized Controlled Trials (RCTs), typically lasting two to three weeks. These studies monitored signs and symptoms—such as redness, swelling, and itching—for common inflammatory conditions like Atopic Dermatitis (Eczema) and Psoriasis Vulgaris.


Q: What ingredients besides the active one are in Afloderm?

The Cream and Ointment formulations contain the active ingredient Alclometasone dipropionate, plus inactive ingredients (excipients). These excipients can include substances like propylene glycol and petrolatum. For instance, the Cream contains chlorocresol, a common preservative, and it also includes cetostearyl alcohol, which is noted as potentially causing local skin reactions in some people.


Q: Are there research studies comparing Afloderm to a placebo?

Yes, the clinical evidence for Afloderm is derived from controlled comparative studies and Randomized Controlled Trials (RCTs). These types of trials typically involve comparing the medication's effect against a non-active control (a placebo) to accurately evaluate its effectiveness for the approved uses.


Q: What is the general safety classification of Afloderm for topical use?

Afloderm is officially classified as a low-to-medium potency topical corticosteroid. When used as directed, the medication's low-to-medium potency is intended to balance effectiveness with a minimized risk profile. However, official warnings mention the risk of systemic effects, such as HPA axis suppression, which increases with prolonged use or application over large body surface areas.


Q: Is Afloderm related to cortisone injections?

Afloderm is a topical medicine containing Alclometasone dipropionate, which is a synthetic glucocorticoid, a type of corticosteroid. Cortisone injections also contain synthetic glucocorticoids, meaning both the topical medicine and the injections belong to the same general pharmacological class of steroid drugs.


Q: Is Afloderm ever used to treat minor burns or insect bites?

The primary approved uses for Afloderm are for inflammatory skin conditions such as eczema and dermatitis. However, some international regulatory documents have included use for localized inflammatory reactions caused by insect bites and stings.


Q: Are there any official warnings about driving or operating machinery while using Afloderm?

Official regulatory information does not contain specific warnings indicating that Afloderm is expected to affect a person's ability to drive or safely operate heavy machinery.


Q: What are the signs that Afloderm is not working for a condition?

Official guidance specifies that if a patient observes no clinical improvement in their condition within a two-week period of treatment, the regulatory guidance states that the diagnosis is to be reassessed. Worsening of the skin condition is also documented as a possible adverse reaction.


Q: Can Afloderm be used on broken skin?

The official documents strictly advise against using the product on skin with untreated infections. They also warn that the risk of systemic effects is increased with use on damaged or broken skin where the skin barrier is compromised, as this can lead to greater absorption of the medicine.


Q: Does Afloderm contain any fragrances or preservatives?

The product formulations do not list any fragrance or perfume ingredients. However, the formulations do contain excipients (inactive ingredients) such as chlorocresol, which functions as a common preservative.


Q: Are there any foods or supplements that interact with Afloderm?

The official regulatory labeling for Afloderm does not specify any interaction restrictions or effects concerning food, alcohol, herbal products, or supplements. The only formal documented interaction is with other products containing corticosteroids.


Q: Can Afloderm cause changes in skin color?

Official regulatory documents have listed changes in the color of the treated skin (pigmentation changes) as a possible, though typically infrequent, side effect of the medicine.


Q: Is it common to feel a stinging or burning sensation when first applying Afloderm?

Yes, official documents describe burning at the application site as a commonly reported local side effect of Afloderm. This sensation is noted as a frequent occurrence when the medication is applied.


Q: What are the main side effects listed for children using Afloderm?

Children are noted to have a higher susceptibility to systemic effects due to their body composition. The main systemic concerns are the potential for Hypothalamic-Pituitary-Adrenal (HPA) axis suppression and growth retardation. Local side effects reported in children are generally similar to those seen in adults.


Q: What are the differences between Afloderm ointment and Afloderm cream?

Both the Cream and Ointment contain the same active ingredient but use different inactive base vehicles. The Cream uses a water-washable base, which is lighter. The Ointment is described as utilizing a heavier, occlusive, emollient base, which typically makes it useful for dry or thick skin areas. This difference influences how the product is generally used.

How should Afloderm be stored and disposed of?

The storage and disposal of Afloderm (alclometasone dipropionate) are strictly defined by regulatory guidelines to maintain product integrity and safety.

Storage Requirements

Afloderm Cream and Ointment must be stored at Controlled Room Temperature (CRT), which is between 20 C to 25 C (68 F to 77 F). The product must be kept out of the reach of children. It is mandatory to keep the container tightly closed in the original packaging and do not freeze the medicine, as freezing can compromise its stability.

Disposal Instructions

Unused or expired Afloderm must be disposed of according to local regulations for pharmaceutical waste. The product should generally not be disposed of in wastewater or household trash to prevent environmental contamination, unless specifically authorized by local guidance.

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

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