Corticosteroids, very potent (group IV)

Clobetasol Propionate

Approved 21 Apr 2022TopicalAerosol, foam

The FDA lists this product in 60 strengths and forms.

Indications

Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.

( 1 )

Contraindications

None. None ( 4 )

Warnings and precautions

Clobetasol propionate foam can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop.

( 5.1 , 8.4 ) Clobetasol propionate foam may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) Clobetasol propionate foam is flammable. Avoid fire, flame, or smoking during and immediately following application. ( 5.4 )

5.1Effects on Endocrine System

Clobetasol propionate foam can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of clobetasol propionate foam on the HPA axis, 13 subjects applied clobetasol propionate foam to at least 20% of involved body surface area for 14 days. HPA axis suppression was identified in 5 out of 13 subjects (38%) [see Clinical Pharmacology (12.2) ] . If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on clobetasol propionate foam use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible ( see Data ).

In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49 to 40.11)].

In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month (range, 12 to170 g) over long periods of time. Animal Data Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg.

Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.

Adverse reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Effects on Endocrine System [see Warnings and Precautions (5.1) ] Ophthalmic Adverse Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥ 4%) are application site burning and other application site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a controlled clinical trial involving 188 subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the subjects treated with clobetasol propionate foam.

In 2 controlled clinical trials with clobetasol propionate foam in 360 subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the subjects treated with clobetasol propionate foam included application site burning (10%), application site dryness (<1%), and other application site reactions (4%). In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

6.2Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local adverse reactions to topical corticosteroids may include: striae, itching, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

Ophthalmic adverse reactions may include: cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

Clobetasol Propionate

Indications

Contraindications

Warnings and precautions

5.1Effects on Endocrine System

Two medicines in one question?

5.2Ophthalmic Adverse Reactions Use

5.3Allergic Contact Dermatitis

5.4Flammable Contents

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance

Guidelines