Clobetasol Propionate Ointment/Clobetasol Propionate is the propionate salt form of clobetasol, a topical synthetic corticosteroid with anti-inflammatory, anti-pruritic, and vasoconstrictive properties. Clobetasol propionate exerts its effect by binding to cytoplasmic glucocorticoid receptors and subsequently activates glucocorticoid receptor-mediated gene expression. This results in the synthesis of certain anti-inflammatory proteins while inhibiting the synthesis of certain inflammatory mediators. Specifically, clobetasol propionate appears to induce phospholipase A2 inhibitory proteins, thereby controlling the release of the inflammatory precursor arachidonic acid from membrane phospholipids by phospholipase A2.
Clobetasol propionate is the 17-O-propionate ester of clobetasol. A potent corticosteroid, it is used to treat various skin disorders, including eczema and psoriasis. It has a role as an anti-inflammatory drug. It is an 11beta-hydroxysteroid, a 20-oxo steroid, a glucocorticoid, a fluorinated steroid, a 3-oxo-Delta(1), Delta(4)-steroid and a chlorinated steroid. It derives from a clobetasol and a propionic acid.
Mechanism of Action of Clobetasol Propionate
The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Initially, however, clobetasol, like other corticosteroids, binds to the glucocorticoid receptor, which complexes, entrees the cell nucleus and modifies genetic transcription (transrepression/transactivation).
Receptor for glucocorticoids (GC). It has a dual-mode of action: a transcription factor that binds to glucocorticoid response elements (GRE), both for nuclear and mitochondrial DNA and as a modulator of other transcription factors. It affects inflammatory responses, cellular proliferation, and differentiation in target tissues. Could act as a coactivator for STAT5-dependent transcription upon growth hormone (GH) stimulation and could reveal an essential role of hepatic GR in the control of body growth. Involved in chromatin remodeling. May play a negative role in adipogenesis through the regulation of lipolytic and antilipogenic gene expression.
Indications of Clobetasol Propionate
- For the short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp.
- Mild Plaque psoriasis
- Moderate Dermatosis
- Moderate Plaque psoriasis
- Severe Dermatosis
- Anal Itching
- Dermatitis
- Atopic Dermatitis
- Cutaneous T-cell Lymphoma
- Dermatological Disorders
- Eczema
- Lichen Planus
- Lichen Sclerosus
- Necrobiosis Lipoidica Diabeticorum
- Plantar Fibromatosis
- Psoriasis
- Seborrheic Dermatitis
- Relief of corticosteroid-responsive inflammatory and pruritic dermatoses; psoriasis; recalcitrant eczemas, lichen planus, discoid lupus erythematosus, and other conditions which do not respond satisfactorily to less active steroids
- Clobetasol propionate shares the actions of other topical corticosteroids and is used for the short-term relief of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, including plaque psoriasis and dermatoses of the scalp (e.g., scalp psoriasis).
- Clobetasol propionate is used for the treatment of various skin disorders including eczema, herpes labialis, psoriasis, and lichen sclerosis. It is also used to treat several auto-immune diseases including alopecia areata, lichen planus (autoimmune skin nodules), and mycosis fungoides (T-cell skin lymphoma). It is used as a first-line treatment for both acute and chronic GVHD of the skin.
- Clobetasol propionate is used cosmetically by dark-skinned women for skin whitening, although this use is controversial. The U.S. Food and Drug Administration has not approved it for that purpose, and sales without a prescription are illegal in the U.S.
- Nonetheless, skin-whitening creams containing this ingredient can sometimes be found in ethnic beauty supply stores. It is also sold internationally and does not require a prescription in some countries. Whitening creams with clobetasol propionate, such as Hyprogel, can make skin thin and easily bruised, with visible capillaries, and acne. It can also lead to hypertension, elevated blood sugar, suppression of the body’s natural steroids, and stretch marks, which may be permanent.[rx]
Contraindications of Clobetasol Propionate
- Acne vulgaris
- Dermatitis around the mouth
- Itching around the anus and genitals
- Rosacea
- Corticosteroid hypersensitivity.
- Cushing’s syndrome, hepatic disease, hypothalamic-pituitary-adrenal (HPA) suppression, occlusive dressing, skin abrasion.
- Diabetes mellitus.
- Children, growth inhibition, increased intracranial pressure, infants, neonates.
- Pregnancy.
- Breast-feeding.
Dosage of Clobetasol Propionate
Strengths: 0.05%; 0.05% with cleanser; 0.05% with emollients; 0.025%
Dermatitis
- The solution, spray, ointment, gel, foam, lotion, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely.
- Shampoo: Apply to dry scalp once a day in a thin film to the affected areas only and leave in place for 15 minutes before lathering and rinsing.
- Maximum dose: The total dosage should not exceed 50 g (50 mL or 1.75 fluid ounce) per week.
Eczema
- The solution, spray, ointment, gel, foam, lotion, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely.
- Shampoo: Apply to dry scalp once a day in a thin film to the affected areas only and leave in place for 15 minutes before lathering and rinsing.
- Maximum dose: The total dosage should not exceed 50 g (50 mL or 1.75 fluid ounce) per week.
Psoriasis
- The solution, spray, ointment, gel, foam, lotion, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely.
- Shampoo: Apply to dry scalp once a day in a thin film to the affected areas only and leave in place for 15 minutes before lathering and rinsing.
Dermatological Disorders
- The solution, spray, ointment, gel, foam, lotion, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely.
- Shampoo: Apply to dry scalp once a day in a thin film to the affected areas only and leave in place for 15 minutes before lathering and rinsing.
- Maximum dose: The total dosage should not exceed 50 g (50 mL or 1.75 fluid ounce) per week.
Dermatitis
- The solution, ointment, gel, foam, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely. Not recommended for use in children under 12 years of age.
- Shampoo, spray, and lotion formulations: Not recommended for use in children under 18 years of age.
- Maximum dose: The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Eczema
- The solution, ointment, gel, foam, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely. Not recommended for use in children under 12 years of age.
- Shampoo, spray, and lotion formulations: Not recommended for use in children under 18 years of age.
- Maximum dose: The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Pediatric Dose for Psoriasis
- The solution, ointment, gel, foam, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely. Not recommended for use in children under 12 years of age.
- Shampoo, spray, and lotion formulations: Not recommended for use in children under 18 years of age.
- Maximum dose: The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Pediatric Dose for Dermatological Disorders
- The solution, ointment, gel, foam, cream formulations: Apply a thin layer to affected areas twice a day and rub in gently and completely. Not recommended for use in children under 12 years of age.
- Shampoo, spray, and lotion formulations: Not recommended for use in children under 18 years of age.
- Maximum dose: The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Side Effects of Clobetasol Propionate
More common
- Burning or stinging at the application site
- burning, dryness, irritation, itching, or redness of skin (usually mild and temporary)
- eye pain (if certain products have been used near the eye)
- headache
- increased redness or scaling of skin sores (usually mild and temporary)
- skin color changes
- skin infection
- skin rash (usually mild and temporary)
- softening and tearing of the skin
- thinning of the skin with easy bruising
Less common
- Burning sensation of the skin
- dry skin
- flushing or redness of the skin
- itching, scaling, severe redness, soreness, or swelling of the skin
- skin irritation
- skin rash, encrusted, scaly and oozing
- thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
Rare
- Thinning, weakness, or wasting away of the skin
- Acne or pimples
- burning and itching of the skin with pinhead-sized red blisters
- increased hair growth on the forehead, back, arms, and legs
- lightening of normal skin color
- lightening of treated areas of dark skin
- reddish purple lines on the arms, face, legs, trunk, or groin
- softening of the skin
Drug Interactions of Clobetasol Propionate
Clobetasol Propionate may interact with following drugs, supplements & may change the efficacy of drugs
- Aspirin Low Strength (aspirin)
- Diphenhydramine
- Rosuvastatin
- Cymbalta (duloxetine)
- Fish Oil (omega-3 polyunsaturated fatty acids)
- Fluticasone nasal
- Atorvastatin
- Pregabalin
- Metoprolol Succinate ER (metoprolol
- Polyethylene glycol 3350
- Esomeprazole
- Albuterol
- Montelukast
- Levothyroxine
- Acetaminophen
- Vitamin B12 (cyanocobalamin)
- Vitamin C (ascorbic acid)
- Vitamin D3 (cholecalciferol)
- Alprazolam
- Cetirizine
Clobetasol topical disease interactions
- Diabetes
- Diaper rash
- Hyperadrenocorticism
- Infections
- Ocular toxicities
Pregnancy Category of
- FDA Pregnancy Category – C
- TGA Pregnancy Category – B3
Pregnancy
This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.
Lactation
This medication may pass into breast milk. If you are a breast-feeding mother and are using clobetasol propionate, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Children are more likely to experience the absorption of this medication into the bloodstream, resulting in unwanted effects. The safety and effectiveness of using this medication have not been established for children. Its use by children is not recommended.
How should I use this medication?
- Cream and ointment – Apply the medication sparingly to cover the affected area and gently rub it into the skin 2 or 3 times daily. The total dose applied should not be more than 50 g in a week. Use this medication with caution on lesions near the eye. Take care to prevent it from getting into the eye.
- Lotion – Apply the lotion to the affected areas of skin 2 times daily and rub it in gently and completely. The total dose should not exceed 50 g (50 mL) in a week.
- Scalp lotion – Apply the lotion 1 or 2 times daily to the affected areas of the scalp and rub in gently. The total dose should not exceed 50 mL in a week. Clobetasol scalp applications should not be used near an open flame.
- Foam – Apply a thin layer of foam 2 times daily to the affected areas of the skin and rub in gently until the foam is absorbed. The foam is extremely flammable, so avoid fire, flames, sparks or smoking during and immediately after applying. The total dose applied should not exceed 50 g in a week.
- Spray – Apply the solution 2 times daily to the affected areas of the skin and rub in gently. The total dose should not exceed 50 mL in a week.
- Shampoo – A thin film of clobetasol shampoo should be applied directly to the affected area of the scalp once daily. The shampoo is applied to the lesions on dry scalp and rubbed in gently. Leave it on for 15 minutes before wetting the hair, lathering, and rinsing. The total dose applied should not be more than 50 mL in a week.
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