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Topical Clobetasol Propionate: Only Use to Treat Severe Skin Disorders

Worst Pills, Best Pills Newsletter article June, 2018

Clobetasol propionate (CLOBEX, CORMAX, EMBELINE, IMPOYZ, OLUX) was approved by the Food and Drug Administration (FDA) in 1985 for the relief of inflammation and itching caused by skin diseases that are responsive to corticosteroids (also called glucocorticoids).[1] Like other topical corticosteroids, clobetasol suppresses inflammation and itching and decreases blood flow to areas of application.

Clobetasol is available in multiple topical formulations, including creams, foam aerosols,...

Clobetasol propionate (CLOBEX, CORMAX, EMBELINE, IMPOYZ, OLUX) was approved by the Food and Drug Administration (FDA) in 1985 for the relief of inflammation and itching caused by skin diseases that are responsive to corticosteroids (also called glucocorticoids).[1] Like other topical corticosteroids, clobetasol suppresses inflammation and itching and decreases blood flow to areas of application.

Clobetasol is available in multiple topical formulations, including creams, foam aerosols, gels, ointments, shampoos, solutions and sprays. All marketed clobetasol products have a 0.05-percent strength except for Impoyz cream, which has a 0.025-percent strength. Some formulations are approved only for adults,[2] whereas others are approved for adults and children as young as 12.

A super-high potency corticosteroid

Topical corticosteroids are classified into seven groups based on their potency (see table).[3] The potency is determined by the chemical makeup of the active ingredient, the strength and the formulation. Corticosteroids that contain fluorine are more potent than those that do not contain fluorine.

All clobetasol products — except Impoyz cream, which is approved by the FDA only for moderateto- severe psoriasis[4] — are classified as super-high potency (group 1) corticosteroids and are approximately 1,000 times more potent than 1-percent hydrocortisone (ALACORT, ALA-SCALP, CORTAID, CORTIZONE 10), one of the least potent topical corticosteroids. Impoyz cream, 0.025 percent, is a high-potency (group 2) corticosteroid.

Clobetasol generally is reserved for treating severe cases of skin diseases, such as severe psoriasis, atopic dermatitis (a type of eczema) and contact dermatitis (for example, poison ivy), that have not responded to corticosteroids with lower potency. Therefore, Public Citizen’s Health Research Group has designated clobetasol as Limited Use.

Super-high potency corticosteroids like clobetasol are particularly useful for treating skin diseases affecting the palms of the hands and soles of the feet, which have very thick outer layers of skin that are resistant to penetration by lower-potency topical drugs.

Because of its super-high potency, clobetasol generally should not be used for longer than two consecutive weeks (four weeks for localized moderate-tosevere psoriasis) to minimize the risk of serious adverse effects.[5],[6]

Seven Classes of Topical Corticosteroids and Examples of Each

Potency Group Active Ingredient, Formulation(s), Strength(s) Brand Name(s)
Super-high potency (group 1)
betamethasone dipropionate, augmented; gel, lotion and optimized ointment; 0.05 percent DIPROLENE
clobetasol propionate, multiple formulations, 0.05 percent CLOBEX, CORMAX, EMBELINE, OLUX
fluocinonide, cream, 0.1 percent VANOS
halobetasol propionate; cream, lotion and ointment; 0.05 percent ULTRAVATE
High potency (group 2)
amcinonide, ointment, 0.1 percent generic only
betamethasone dipropionate, cream (augmented formulation), 0.05 percent DIPROLENE AF
clobetasol propionate, cream, 0.025 percent IMPOYZ
fluocinonide; cream, gel, ointment and solution; 0.05 percent LIDEX
High potency (group 3)
amcinonide, cream and lotion, 0.1 percent generic only
fluticasone propionate, ointment, 0.005 percent CUTIVATE
mometasone furoate, ointment, 0.1 percent ELOCON
triamcinolone acetonide, cream, 0.5 percent TRIDERM
Medium potency (group 4)
betamethasone dipropionate, spray, 0.05 percent SERNIVO
flurandrenolide, ointment, 0.05 percent CORDRAN
hydrocortisone valerate, ointment, 0.2 percent generic only
mometasone furoate, cream and lotion, 0.1 percent ELOCON
Lower-mid potency (group 5)
betamethasone valerate, cream, 0.1 percent BETA-VAL, DERMABET, VALNAC
desonide, gel and ointment, 0.05 percent DESONATE, DESOWEN
flurandrenolide, cream and lotion, 0.05 percent CORDRAN, CORDRAN SP
hydrocortisone valerate, cream, 0.2 percent generic only
Low potency (group 6)
alclometasone dipropionate, cream and ointment, 0.05 percent generic only
betamethasone valerate, lotion, 0.1 percent generic only
desonide; cream, foam and lotion; 0.05 percent DESOWEN, VERDESO
triamcinolone acetonide, cream and lotion, 0.025 percent TRIDERM
Least potency (group 7)
hydrocortisone; cream, foam, lotion, ointment and solution; 0.5, 1, 2 and 2.5 percent ALA-CORT, ALA-SCALP, ANUSOL HC, CORTAID,* CORTIZONE 10,* STIE-CORT, TEXACORT
*Available over-the-counter

Adverse effects[7]

High and super-high potency corticosteroids like clobetasol can be absorbed into the blood through the skin. This can reversibly suppress the production of natural glucocorticoid hormones, such as cortisol, by the adrenal glands. As a result, patients may experience signs and symptoms of adrenal insufficiency during or shortly after clobetasol treatment. Symptoms of adrenal insufficiency include fatigue, muscle weakness, loss of appetite, nausea, vomiting, dizziness (particularly upon standing) and fainting.

Due to its absorption through the skin, clobetasol also may lead to Cushing’s syndrome — a disorder caused by excessive glucocorticoid hormones and characterized by weight gain; pink or purple stretch marks; and thinning, fragile skin that bruises easily — and high blood sugar or diabetes.

Factors that increase the risk of these hormone-related problems with clobetasol treatment include use over a large skin surface area, use for prolonged periods, use with an occlusive dressing (for example, a plastic wrap placed over the site of application), use in children and liver disease.

Clobetasol should not be applied to the face, underarms or groin areas. It can cause several adverse skin effects, including folliculitis (inflammation of hair follicles), acne-like lesions, loss of skin pigmentation, allergic contact dermatitis, infections and skin atrophy (thinning).

What You Can Do

If you have a skin condition that requires treatment with a topical corticosteroid, you should only use clobetasol after trying corticosteroids with lower potencies.

You should use clobetasol for the shortest period necessary and for no longer than two weeks (or four weeks for severe psoriasis). You should never apply clobetasol to your face, underarms or groin area. Avoid any contact of the drug with the eyes and lips.

Contact your doctor promptly if you develop symptoms of adrenal insufficiency or Cushing’s syndrome, if you develop signs of a skin infection or if your skin condition is not improving or is worsening with treatment.

References

[1] Galderma Laboratories. Label: clobetasol propionate lotion (CLOBEX). February 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54eca64c-af43-48ba-bf86-bab9d8e46bb6. Accessed April 5, 2018.

[2] Galderma Laboratories. Label: clobetasol propionate lotion (CLOBEX). February 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54eca64c-af43-48ba-bf86-bab9d8e46bb6. Accessed April 5, 2018.

[3] Goldstein BG, Goldstein AO. General principles of dermatologic therapy and topical corticosteroid use. UpToDate. December 18, 2017. https://www.uptodate.com/contents/general-principles-of-dermatologic-therapy-and-topical-corticosteroid-use. Accessed April 5, 2018.

[4] Promius Pharma. Label: clobetasol propionate cream (IMPOYZ), 0.025%. November 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209483s000lbl.pdf. Accessed April 5, 2018.

[5] Galderma Laboratories. Label: clobetasol propionate lotion (CLOBEX). February 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54eca64c-af43-48ba-bf86-bab9d8e46bb6. Accessed April 5, 2018.

[6] Promius Pharma. Label: clobetasol propionate cream (IMPOYZ). November 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209483s000lbl.pdf. Accessed April 5, 2018.

[7] Galderma Laboratories. Label: clobetasol propionate lotion (CLOBEX). February 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54eca64c-af43-48ba-bf86-bab9d8e46bb6. Accessed April 5, 2018.