Dermasone

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Medically reviewed

Laura Arias

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 Dermasone

Quick Facts

Property Description
Active ingredient Clobetasol Propionate
Form Topical Cream, Ointment, Gel, Foam, or Solution
Pharmacological class Corticosteroid (Super-high Potency)
Common use Anti-inflammatory and Anti-pruritic
Origin Synthetic

What Type of Medicine is Dermasone?

Dermasone is classified as a prescription-only medicinal product, representing a super-high potency topical corticosteroid, intended solely for external application to the skin. Its therapeutic efficacy is derived from its core active chemical entity, Clobetasol Propionate, which is a synthetic fluorinated steroid. This potent compound belongs to the highest tier of the corticosteroid class. This distinct potency level is a key differentiating feature, marking it for use in conditions where rapid and intensive anti-inflammatory action is clinically required, unlike lower-strength, over-the-counter options.

Composition, Forms, and General Therapeutic Purpose

This medication is supplied as a single-entity product based on Clobetasol Propionate and is available in various specialized dosage forms, including a cream, ointment, gel, foam, and solution, all designed for topical administration. The differing bases, such as the occlusive hydrocarbon ointment base or the lighter emollient cream base, allow the preparation to be precisely adapted for specific skin locations. The general purpose of Dermasone is to provide highly effective, localized relief. This is achieved through powerful anti-inflammatory and immunosuppressive properties to address severe skin manifestations. This strong effect aids in rapidly lessening the symptoms of highly reactive dermatoses, targeting intense pruritus (itching), visible redness, and pronounced swelling.

Regulatory References

  1. FDA DailyMed source
  2. NIH MedlinePlus

What side effects are possible with Dermasone?

Possible Side Effects and Safety Information

As a super-high potency topical corticosteroid, the safety profile of Dermasone is defined by the potential for both local dermatological reactions and systemic effects due to absorption. Regulatory documents classify adverse reactions based on frequency and affected organ system.


Official Adverse Reaction Categories

Classification Examples of Officially Listed Adverse Reactions
Common (Local Effects) Skin atrophy (thinning), telangiectasia (spider veins), burning, stinging, irritation, and dryness at the application site.
Systemic Risk (Less Common) Hyperglycemia, glucosuria, and endocrine disorders (e.g., manifestations of Cushing's syndrome or Adrenal suppression).
Ophthalmic Risk Documented potential for increased risk of cataracts and glaucoma.

Key Safety Considerations

The risk of serious adverse effects, primarily Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, is associated with the medication's high potency. This risk is explicitly tied to duration of use, application over large surface areas, and the use of occlusive dressings, as noted in official regulatory information.

Population-Specific Safety: Pediatric patients are documented as being at a significantly higher risk of systemic toxicity, including HPA axis suppression and growth retardation, due to a greater surface area-to-body mass ratio.

Restrictions on Use: Safety labeling recommends that application should be avoided on highly sensitive areas, including the face, groin, and axillae. The medicine is also officially contraindicated for use in conditions such as rosacea and perioral dermatitis.

Overdose and Emergency Response

The official regulatory documentation for Dermasone addresses overdose primarily in the context of chronic excessive use or over-absorption rather than a single acute event. As a super-high potency topical corticosteroid, prolonged application over large body surface areas or under occlusive dressings increases the risk of systemic absorption.

Documented Overdose Manifestations

The most critical physiological manifestation documented is Hypothalamic-Pituitary-Adrenal (HPA) axis suppression. Clinical signs of systemic toxicity include manifestations of Hypercortisolism (Cushing’s syndrome), along with laboratory findings such as hyperglycemia and glucosuria. A severe, life-threatening outcome that may occur is glucocorticosteroid insufficiency (adrenal crisis) following abrupt cessation of the medication. Pediatric patients are officially documented as being more susceptible to systemic adverse effects due to their body surface area to body weight ratio.

Required Emergency Actions

Immediate medical attention must be sought for any signs that may indicate adrenal gland problems, such as unusual fatigue, vomiting, or dizziness. Additionally, contact with a regional poison control center is advised for management of a suspected overdose. There is no specific antidote documented for this type of overdose.

Supportive Management

The regulator-mandated management protocol for documented HPA axis suppression involves the gradual withdrawal of the drug or substitution with a less potent steroid. Supplemental systemic corticosteroids may be required if signs of adrenal insufficiency are present. Periodic evaluation of HPA axis function is required for those at systemic exposure risk.

Therapeutic Uses of Dermasone

This class of medication is commonly used to help with symptoms related to inflammatory or irritative states. It is applied in clinical settings that involve acute or unstable symptom patterns where additional support for symptom management is appropriate. Dermasone is relevant for easing challenging symptoms associated with conditions like atopic dermatitis (eczema), contact dermatitis, and psoriasis.

This medication helps address symptom clusters that may become intense or disruptive, contributing to improved comfort during periods of heightened symptoms. It is used in situations involving certain distressing symptoms, primarily focusing on redness, swelling, intense itching, and visible scaling.

Symptomatic relief helps patients cope more steadily with difficult episodes and supports patients during difficult episodes by easing distress during symptomatic phases.

This supportive therapy supports daily comfort when symptoms interfere with routine activities, particularly when symptoms create noticeable physiological strain and become temporarily overwhelming.

Quick Fact: Relief for Itching and Swelling

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility Profile

Dermasone (Clobetasol Propionate) is a super-high potency topical corticosteroid, and its use is governed by strict, specific rules set by government regulatory bodies. Eligibility is primarily limited by age, pre-existing conditions, and application site.


Eligibility Scope Regulatory Classification
Populations Allowed Adults and adolescents 12 years of age and older are eligible for most forms. Specific forms may be limited to ages 16 or 18 and older.
Populations Contraindicated Must not be used by patients with a history of hypersensitivity to any component, rosacea, perioral dermatitis, or untreated skin infections.
Age-Related Rule Use in children under 12 years of age is not recommended due to increased risk of systemic absorption (HPA axis suppression).
Reproductive Status Pregnancy use is conditional, only if the potential benefit justifies the potential risk to the fetus. Caution is required during lactation, and application to the breast/nipple area is restricted.
Site Restrictions Must not be applied to the face, groin, or axillae (underarms), nor should it be used if skin atrophy is already present at the site.

Official labeling defines who can and cannot use the medicine by establishing absolute prohibitions for certain populations and specific conditions, ensuring Dermasone is used only by approved age groups and on restricted body areas to manage the risks associated with its potency.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Dermasone (typically a medium-to-high potency topical corticosteroid) has a limited interaction profile primarily related to its potential for systemic absorption, which is the amount of medicine that enters the bloodstream through the skin.

Documented Interaction Domains

The most significant interaction concerns are with agents that can affect the body's metabolism of the corticosteroid or contribute to an excessive cumulative corticosteroid exposure.

Interaction Domain Potential Effect and Constraint
Other Corticosteroids (Topical or Systemic) Concomitant use increases the risk of additive systemic effects, such as HPA axis suppression and hyperglycemia. Official labeling often restricts or requires close monitoring for this combination.
Strong CYP3A4 Inhibitors These medicines can inhibit the enzyme responsible for breaking down the corticosteroid, potentially leading to increased systemic exposure of Dermasone. This requires close monitoring for systemic corticosteroid adverse effects.

Contextual Constraints

Official regulatory information emphasizes that the risk of interaction, and the severity of systemic effects, is increased by factors that promote higher systemic absorption. These factors include applying the product over a large surface area, prolonged duration of use, or application under occlusive dressings. Pediatric patients are identified as a population with an increased risk of systemic effects, and therefore, an increased risk for interaction-related toxicity, due to their higher skin surface area to body mass ratio.

Mechanism of Action

How Dermasone Works

The mechanism of Dermasone (Clobetasol Propionate) is defined by its action as a high-affinity Glucocorticoid Receptor ( GR) agonist, resulting in extensive modulation of local inflammatory and immune pathways. The drug's primary action involves binding to the GR inside skin cells, and the resulting complex modulates gene expression through two main processes.

One process, transrepression, suppresses the function of pro-inflammatory transcription factors, such as NF-kappa B, reducing the synthesis of inflammatory messengers. The second process, transactivation, increases the production of anti-inflammatory proteins, notably Annexin A1. Annexin A1 then indirectly inhibits the enzyme Phospholipase A2 ( PLA2), thereby blocking the Arachidonic Acid Cascade, which is responsible for synthesizing local inflammatory mediators like prostaglandins and leukotrienes.

Additionally, the drug induces rapid vasoconstriction of small dermal blood vessels. This immediate action decreases the leakage of fluid and cells from capillaries into the tissue, resulting in a physiological adjustment of local fluid dynamics and dermal perfusion.

Dosage and Administration Information

Dermasone, containing Clobetasol Propionate, is strictly a topical medication, intended solely for application to the skin or scalp and is not for oral, ophthalmic, or intravaginal use. The medication is available in various 0.05% formulations, including cream, ointment, gel, solution, and shampoo, with administration rules varying by form.

Administration Guidelines

Parameter Instruction
Route of Administration Topical only; external application to skin or scalp.
Dosing Frequency Typically twice daily (BID) for most topical forms (cream, ointment, etc.). The shampoo is applied once daily (QD).
Maximum Dosage The total amount applied must not exceed 50 grams (or 50 mL) over the course of one week.
Treatment Duration Use is limited to a short course, generally two consecutive weeks. For certain conditions like plaque psoriasis, some forms may be extended up to four consecutive weeks.

Application Context and Limitations

For general application, a thin layer of the medication should be gently rubbed into the affected area. Treatment should be discontinued when the condition is controlled, even if the prescribed duration has not been completed. The treated area must not be covered with occlusive dressings (bandages or wrapping) unless specifically directed. Application must be avoided on the face, groin, or axillae. Current clinical guidelines generally do not recommend use in children younger than 12 years of age.

This strictly defined usage protocol, including the limited duration and maximum weekly dose, structures the method for administering this high-potency agent.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dermasone (Clobetasol Propionate)


Evidence for Use in Plaque Psoriasis and Atopic Dermatitis

The evidence supporting the regulatory review of Dermasone is primarily based on research, derived from short-term Randomized Controlled Trials (RCTs) and systematic reviews. The research examined conditions which includes fluctuating or episodic manifestations and consistently monitored outcomes related to inflammatory or irritative states. Researchers included adults and adolescents (age 12 and older) in these trials.

The studies examined short-term symptom changes over defined time intervals, usually lasting only a few weeks. The key outcomes monitored were physical measurements of the skin, such as changes in redness (erythema), plaque thickness, and scaling, as well as patient-reported outcomes describing perceived discomfort like itching. Findings describe patterns observed in the studies, which included measured changes in these clinical endpoints during the short periods of observation.


Evidence for Use in Recalcitrant Dermatoses

Research exploring this medicine was conducted for other severe inflammatory skin conditions—often grouped as recalcitrant dermatoses—and comes from both short-term RCTs and clinical observation settings. These studies focused on episodes where symptoms become more noticeable.

Data show patterns related to clinical measurements and monitored variables related to inflammation when the medicine was applied to these targeted skin areas. Because these studies involve diverse, specific skin conditions, the findings were sometimes mixed, which is a common observation in research related to complex, varied dermatoses.


Long-Term Studies and Observation Periods

The vast majority of the core research focused on its effects over a short-term follow-up duration, typically lasting only two to four weeks. This short duration is a recognized feature of the research base for this class of medicine. As a result, long-term effects are not well characterized by the initial, pivotal trials. The evidence is limited regarding the patterns of sustained change or the durability of observed changes beyond the initial treatment period.

Key Studies & References

  1. A Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing with Clobetasol Propionate Cream (Impoyz™), 0.025% versus Clobetasol Propionate (Temovate®)
  2. Evaluation of the Efficacy and Safety of Clobetasol Propionate Spray in the Treatment of Plaque-Type Psoriasis
  3. Clobetasol Propionate Shampoo 0.05% Is Efficacious and Safe for Long-term Control of Scalp Psoriasis

Frequently Asked Questions (FAQ)

Common questions about Dermasone (FAQ)


Q: What is Dermasone used for?

A: Dermasone is indicated for the treatment of certain skin conditions. The specific approved uses are detailed in the product's official prescribing information.


Q: How long does it take for Dermasone to work?

A: The time it may take to observe an effect can vary among individuals and depends on the condition being treated. For specific guidance on the expected timeline, consultation with a healthcare provider is recommended.


Q: Can I stop using Dermasone once my symptoms improve?

A: Any changes to your treatment schedule, including stopping the medication, should only be made after consulting with your healthcare provider. Abruptly stopping some medications may lead to the return of symptoms.


Q: What should I do if I miss a dose of Dermasone?

A: If a dose is missed, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not apply a double dose to make up for a missed one. Follow the specific instructions provided by your pharmacist or doctor.


Q: Does Dermasone interact with other medications?

A: Dermasone has the potential to interact with certain other medications, including prescription and over-the-counter products, as well as herbal supplements. It is important to inform your healthcare provider about all substances you are currently using.

How should Dermasone be stored and disposed of?

Dermasone (clobetasol propionate) must be stored at a temperature defined in the official regulatory labeling to ensure product stability and effectiveness.

Item Required Condition
Storage Temperature Controlled Room Temperature: 15 C to 30 C (59 F to 86 F)
Prohibitions Do not refrigerate or do not freeze the product.
Safety & Handling Keep flammable foam/spray products away from heat or open flame. The containers must be protected from high heat and should not be punctured or incinerated.
Child Safety Keep out of reach of children.
Disposal Dispose of unused or expired product according to local regulations for pharmaceutical waste, avoiding disposal in household trash or down the drain.

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

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