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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Clobetasol Propionate Cream 0.05%
Brand Name
Clobetasol Propionate Cream 0.05%
Generic Name
Clobetasol Propionate Cream 0.05%
Active Ingredient
ClobetasolCategory
Azole Antifungal [EPC]
Salt Form
Propionate
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| .5 mg/g | CREAM | TOPICAL | 68788-4001 |
Detailed information about Clobetasol Propionate Cream 0.05%
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Clobetasol Propionate Cream 0.05%, you must consult a qualified healthcare professional.
Clobetasol propionate is a super-high-potency topical corticosteroid used to treat inflammation and itching associated with severe skin conditions like psoriasis and dermatitis. It works by suppressing the immune response and reducing the production of inflammatory chemicals in the skin.
For most inflammatory skin conditions, the standard adult dosage of Clobetasol propionate (0.05%) is a thin layer applied to the affected skin areas twice daily. It is critical to use the smallest amount necessary to cover the area. Clinical guidelines from the American Academy of Dermatology (AAD) emphasize that treatment should be limited to 2 consecutive weeks for most conditions. If treating plaque psoriasis, some formulations may be used for up to 4 weeks, but only if the surface area being treated is less than 10% of the body surface. The total dosage should generally not exceed 50 grams (or 50 mL) per week. If no improvement is seen within 2 weeks, patients must contact their healthcare provider for a re-evaluation of the diagnosis.
Clobetasol is generally not recommended for children under the age of 12. In adolescents (12-17 years), healthcare providers may prescribe it with extreme caution and for the shortest duration possible. Children are at a much higher risk for systemic side effects, such as HPA axis suppression (where the body stops producing its own natural steroids) and Cushing’s syndrome, because they have a larger skin surface area relative to their body weight. If a pediatrician deems Clobetasol necessary, they will typically monitor the child’s growth and development closely. Use in children under 12 is considered off-label and carries significant risks of growth retardation.
There are no specific dosage adjustments provided by the manufacturer for patients with kidney disease, as systemic absorption is typically low. However, patients with end-stage renal disease should be monitored for any unusual systemic effects.
Since Clobetasol is metabolized by the liver, patients with severe hepatic impairment (liver failure) should be treated with caution. Increased systemic levels could lead to a higher risk of adrenal suppression. Healthcare providers may suggest more frequent monitoring or a shorter duration of therapy.
Clinical studies have not identified significant differences in response between elderly and younger patients. However, because older adults often have thinner, more fragile skin, they may be at a higher risk for local side effects like skin tearing or bruising (purpura). Doctors often start with the smallest possible amount for the shortest duration.
If you miss a dose, apply it as soon as you remember. If it is almost time for your next scheduled application, skip the missed dose and return to your regular routine. Do not apply double the amount of medication to make up for a missed dose, as this increases the risk of skin irritation and systemic absorption.
Acute overdose from a single topical application is unlikely. However, chronic over-application (using too much or for too long) can lead to systemic absorption. Signs of chronic overdose include extreme fatigue, muscle weakness, rounding of the face (moon face), weight gain in the upper back/torso, and high blood sugar. If you suspect someone has swallowed the medication, contact a poison control center or seek emergency medical help immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or use the medication for longer than prescribed without medical guidance.
Common side effects of Clobetasol are primarily localized to the site of application. Approximately 10-15% of patients may experience:
These effects are more likely to occur with prolonged use or when treating sensitive areas:
> Warning: Stop taking Clobetasol and call your doctor immediately if you experience any of these serious symptoms. These may indicate systemic absorption or a severe reaction.
Prolonged use of Clobetasol (beyond 4 weeks) significantly increases the risk of irreversible skin damage. Permanent skin thinning (atrophy) can lead to easy bruising and tearing. There is also the risk of "Topical Steroid Withdrawal" (TSW), a controversial but reported condition where the skin becomes intensely red, burning, and inflamed after stopping the medication. To prevent this, doctors usually recommend a "tapering" process where the frequency of application is slowly reduced rather than stopped abruptly.
No FDA black box warnings for Clobetasol. However, the FDA requires strict labeling regarding the risk of HPA axis suppression and the limitation of use to 50 grams per week and a duration of 2 to 4 weeks.
Report any unusual symptoms to your healthcare provider. Monitoring for systemic effects is essential if you are treating large areas of the body.
Clobetasol is a "super-potent" medication and must be handled with care. It is not a general-purpose skin cream and should never be used for minor rashes, diaper rash, or as a moisturizer. Because it is highly absorbed, it can affect internal organs and hormone systems just like oral prednisone. Patients must inform their doctors if they have a history of any skin infections, as Clobetasol can mask the symptoms of an infection or allow it to spread.
No FDA black box warnings for Clobetasol. While it is highly potent, it does not carry the specific boxed warnings associated with some systemic immunosuppressants, provided it is used topically and as directed.
If you are using Clobetasol on a large area of the body or for an extended period, your healthcare provider may require periodic monitoring, including:
Clobetasol is not known to affect the ability to drive or operate machinery. However, if you experience vision changes (like blurred vision) as a side effect, you should avoid these activities until your vision clears and you have consulted a doctor.
There is no direct interaction between topical Clobetasol and alcohol. However, alcohol can sometimes trigger flares of psoriasis or eczema in some patients. Discuss your alcohol consumption with your doctor to see if it might be impacting your skin condition.
Do not stop using Clobetasol suddenly if you have been using it for a long period. Abrupt discontinuation can cause a "rebound" flare, where your skin condition returns worse than before. Your doctor will provide a tapering schedule, such as moving from twice-daily use to once-daily, then every other day, or switching to a lower-potency steroid.
> Important: Discuss all your medical conditions with your healthcare provider before starting Clobetasol, especially if you have a history of skin thinning or adrenal gland problems.
While topical interactions are rare, Clobetasol should not be used concurrently with other high-potency topical corticosteroids (e.g., betamethasone, halobetasol). Using multiple steroids together significantly increases the risk of skin atrophy and systemic HPA axis suppression. There are no absolute systemic drug-drug contraindications for topical Clobetasol, but caution is paramount.
Clobetasol may interfere with several laboratory tests if systemic absorption is high:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those you apply to your skin.
Clobetasol must NEVER be used in the following circumstances:
Healthcare providers will perform a careful risk-benefit analysis in the following cases:
Patients who have experienced an allergic reaction to other "Group A" or "Group D" corticosteroids may also react to Clobetasol. If you have ever had a "patch test" that showed sensitivity to corticosteroids, you must inform your dermatologist before using this product.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Clobetasol. Do not share this medication with others, even if they have similar symptoms.
Clobetasol is classified as Pregnancy Category C by the FDA. This means that studies in animals have shown adverse effects on the fetus (such as cleft palate and low birth weight), but there are no adequate and well-controlled studies in humans. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If used, it should not be used in large amounts or for long periods. There is no evidence that Clobetasol is used in fertility treatments; in fact, high systemic levels of steroids can sometimes disrupt normal hormonal cycles.
It is not known whether topical application of Clobetasol results in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemic corticosteroids are secreted into breast milk. To minimize risk, if Clobetasol is used during lactation, it should be applied to the smallest area possible. Crucially, it should not be applied to the breasts or nipples to prevent the infant from accidentally ingesting the medication or coming into direct contact with it.
Safety and effectiveness in pediatric patients below the age of 12 have not been established. Use in this age group is generally avoided. If used in older children, the duration should be limited to 5 days, and the child must be monitored for HPA axis suppression. Children have a larger ratio of skin surface area to body mass, which leads to a much higher risk of systemic toxicity. There have been reports of intracranial hypertension (increased pressure in the brain) in children using topical steroids, which can cause headaches and vision problems.
In clinical trials, no overall differences in safety or effectiveness were observed between elderly patients and younger patients. However, the skin of older adults is naturally thinner and has less subcutaneous fat. This makes elderly patients more susceptible to local side effects like skin thinning, easy bruising, and delayed wound healing. Doctors often recommend less frequent application or a shorter course of therapy for patients over 65.
No specific dose adjustments are required for patients with renal impairment. However, since a small amount of the drug is excreted by the kidneys, those with severe renal disease should be monitored for any signs of systemic steroid accumulation, though this is clinically rare with topical use.
Clobetasol is metabolized by the liver. Patients with significant hepatic impairment (e.g., Child-Pugh Class B or C) may have a reduced ability to clear the drug from their system if it is absorbed. This increases the risk of HPA axis suppression. These patients should be treated with the lowest effective dose and monitored for signs of Cushing’s syndrome.
> Important: Special populations require individualized medical assessment. Always inform your doctor about your age, pregnancy status, or any organ dysfunction.
Clobetasol propionate is a Class I, super-high-potency corticosteroid. Its molecular mechanism involves binding to the glucocorticoid receptor (GR) in the cytoplasm. The activated GR complex translocates to the nucleus and binds to glucocorticoid response elements (GREs), which regulates the transcription of specific genes. It induces the synthesis of lipocortins, which inhibit phospholipase A2. This inhibition prevents the release of arachidonic acid, thereby blocking the entire inflammatory cascade of prostaglandins and leukotrienes. Additionally, it inhibits the release of various cytokines, such as Interleukin-1 (IL-1), IL-6, and Tumor Necrosis Factor-alpha (TNF-α), which are central to the pathogenesis of psoriasis and eczema.
The pharmacodynamic effects of Clobetasol include anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive actions. The vasoconstrictor assay is often used to determine the potency of topical steroids; Clobetasol produces intense blanching (whitening) of the skin, indicating its high potency. The onset of action is typically rapid, with many patients noticing a reduction in itching and redness within 24 to 48 hours. However, the full therapeutic effect on thick plaques may take 1 to 2 weeks. Tolerance (tachyphylaxis) can develop with continuous use, meaning the drug may become less effective over time, which is another reason for the recommended 2-week limit.
| Parameter | Value |
|---|---|
| Bioavailability | Variable (Highly dependent on skin integrity) |
| Protein Binding | ~90-95% (to Albumin and CBG) |
| Half-life | ~2-5 hours (systemic) |
| Tmax | ~8-12 hours after a single topical application |
| Metabolism | Hepatic (primarily via CYP3A4) |
| Excretion | Renal (primarily) and Fecal/Biliary |
Clobetasol belongs to the therapeutic class of Topical Corticosteroids and is specifically categorized as a Group I (Super-Potent) agent. Related medications in this high-potency class include Halobetasol propionate and Betamethasone dipropionate (in optimized vehicles). It is significantly more potent than hydrocortisone (Group VII) or triamcinolone (Group IV).
Common questions about Clobetasol Propionate Cream 0.05%
Clobetasol is a super-high-potency corticosteroid used to treat severe skin conditions characterized by inflammation and itching. It is most commonly prescribed for moderate to severe plaque psoriasis, recalcitrant eczema (atopic dermatitis), and lichen planus. Because it is so strong, it is usually reserved for cases where milder steroid creams have failed to work. It works by reducing the immune system's activity in the skin, which calms down redness, swelling, and scaling. Healthcare providers typically limit its use to short periods, such as two to four weeks, to prevent serious side effects.
The most common side effects of Clobetasol occur at the site of application and include burning, stinging, or itching of the skin. Some patients also report skin dryness, redness, or the development of small red bumps (folliculitis). These symptoms often occur shortly after the medication is applied and may go away as your skin gets used to the treatment. However, if these symptoms persist or become severe, you should contact your doctor. Because it is a very strong steroid, even these common side effects need to be monitored to ensure the skin is not being damaged.
There is no known direct interaction between topical Clobetasol and alcohol consumption. However, it is important to note that alcohol can be a trigger for certain skin conditions like psoriasis, which Clobetasol is meant to treat. Drinking alcohol may cause a flare-up of your symptoms, potentially making the medication seem less effective. Furthermore, heavy alcohol use can affect liver function, and since Clobetasol is metabolized by the liver, this could theoretically increase the risk of systemic side effects. Always discuss your lifestyle habits with your doctor when starting a new prescription.
Clobetasol is classified as Pregnancy Category C, meaning its safety in pregnant women has not been fully established. Animal studies have shown that high doses of corticosteroids can cause birth defects like cleft palate. In humans, doctors generally only prescribe Clobetasol during pregnancy if the benefits to the mother clearly outweigh the potential risks to the baby. If it is used, it should be applied to the smallest possible area for the shortest amount of time. If you are pregnant or planning to become pregnant, you must discuss the risks and benefits with your healthcare provider before using this medication.
Many patients begin to see an improvement in symptoms like itching and redness within the first 24 to 48 hours of using Clobetasol. However, for more severe conditions like thick plaque psoriasis, it may take one to two weeks of consistent use to see a significant reduction in skin thickness and scaling. If you do not see any improvement after two weeks of use, you should contact your doctor, as they may need to re-evaluate your diagnosis or change your treatment plan. Do not continue using it beyond the prescribed timeframe even if you see improvement, as this increases the risk of skin thinning.
If you have been using Clobetasol for more than a few days, you should not stop using it abruptly without consulting your doctor. Stopping a high-potency steroid suddenly can cause a 'rebound' effect, where your skin condition returns and may even be worse than it was before you started treatment. This happens because the skin becomes accustomed to the steroid's anti-inflammatory effects. Your doctor will usually recommend a tapering schedule, which involves slowly reducing how often you apply the cream until your skin can maintain its health without the medication.
If you miss a dose of Clobetasol, you should apply it as soon as you remember. However, if it is almost time for your next scheduled application, you should skip the missed dose and simply continue with your regular routine. Do not apply a double amount of the cream or ointment to make up for the missed dose. Applying too much medication at once can increase the risk of skin irritation and systemic absorption into your bloodstream. Consistency is key for treating skin flares, so try to use the medication at the same times each day.
When used correctly as a topical cream for a short period, Clobetasol is unlikely to cause significant weight gain. However, if the medication is used over large areas of the body, for a very long time, or under bandages (occlusion), enough of the drug can be absorbed into the bloodstream to cause systemic side effects. One of these side effects is Cushing's syndrome, which can cause weight gain, particularly in the face (moon face) and the upper back (buffalo hump). If you notice unusual weight gain or changes in your body shape while using Clobetasol, notify your doctor immediately.
Clobetasol can interact with other medications, particularly other corticosteroids or drugs that affect your immune system. If you are taking oral steroids like prednisone, the combination with topical Clobetasol can increase your risk of adrenal gland suppression. You should also be cautious when using other topical products on the same area of skin, as they may interfere with how Clobetasol is absorbed. It is vital to provide your doctor with a full list of all medications, including over-the-counter creams, herbal supplements, and vitamins, to ensure there are no dangerous interactions.
Yes, Clobetasol propionate is widely available as a generic medication in many forms, including creams, ointments, lotions, and solutions. Generic versions are required by the FDA to have the same active ingredient, strength, and effectiveness as the brand-name versions (such as Temovate or Cormax). Choosing the generic version can often be a more cost-effective option for patients. However, different manufacturers may use different inactive ingredients (fillers), so if you have sensitive skin or a known allergy to certain preservatives, check the ingredient list with your pharmacist.
Other drugs with the same active ingredient (Clobetasol)