Alclometasone dipropionate shares the actions of other topical corticosteroids and is used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.1,4,5,6,7,8,9,10,11,13,14,17,18
Topical alclometasone dipropionate cream and ointment are applied sparingly in thin films and are rubbed gently into the affected area 2 or 3 times daily.1 The duration of a course of alclometasone therapy may vary from 2-6 weeks,5,6,7,8,9,10,11,13,14,18 although more prolonged therapy23 with appropriate monitoring17 occasionally may be necessary in patients with resistant or chronic conditions. Occlusive dressings may be used for severe or resistant dermatoses.1,17
Alclometasone dipropionate shares the toxic potentials of other topical corticosteroids,1,4,5,6,7,8,11,13,15 and the usual precautions of corticosteroid therapy should be observed.1,17 (See Cautions in the Topical Corticosteroids General Statement 84:06.) In animal studies, there was no evidence of local irritation or anesthetic effect,24 phototoxicity or photosensitization,25 or local immunogenic or antigenic effects26 induced by topical application of alclometasone dipropionate 0.1% ointment or the ointment base.
Alclometasone dipropionate does not appear to suppress the hypothalamic-pituitary-adrenal (HPA) axis following topical application of usual doses.1,4,14 In patients with psoriasis or atopic dermatitis, 15 g of the 0.05% ointment (7.5 mg of alclometasone dipropionate) applied to 30% of the body twice daily for 7 days, including daily 12- or 24-hour periods during which occlusive dressings were applied in some patients, did not affect plasma cortisol concentrations.1,4 In children 3 months to 12 years of age undergoing topical therapy with the drug for various dermatoses (i.e., atopic eczema, seborrheic eczema, diaper dermatitis or psoriasis), plasma cortisol concentrations remained essentially unchanged during therapy with usual dosages of the drug compared with concentrations prior to therapy and after discontinuance of the drug.14 Slight HPA-axis suppression has occurred following topical application of higher than usual dosages.1,4 In healthy individuals with normal skin, a 30-g dose of 0.05% alclometasone dipropionate cream applied topically to 80% of the body twice daily for 21 days, including daily 12-hour periods during which occlusive dressings were applied, slightly decreased plasma cortisol concentrations and urinary free cortisol and 17-hydroxysteroid concentrations; however, treatment values were still within the normal ranges.1,4
Like other topical corticosteroids, alclometasone should not be used in the treatment of acne, rosacea, or perioral dermatitis.22,23 Alclometasone dipropionate preparations are contraindicated in individuals with known hypersensitivity to the drug, other corticosteroids, or any ingredient in the respective formulation.1
Pediatric Precautions 
Alclometasone dipropionate has been used safely and effectively in children undergoing topical therapy for various corticosteroid-responsive dermatoses,5,11,14,18 but the usual precautions associated with topical corticosteroid therapy in children should be observed.1 (See Cautions: Pediatric Precautions, in the Topical Corticosteroids General Statement 84:06.)
Mutagenicity and Carcinogenicity
No evidence of alclometasone-induced mutagenesis was seen in the Ames microbial mutagen test with or without metabolic activation and in several in vitro mammalian cell systems (i.e., mouse lymphoma and mouse erythrocyte assays),23,28 and studies have not shown several other topical corticosteroids (e.g., hydrocortisone, prednisolone) to be mutagenic.1,17 Long-term studies to determine the carcinogenic potential of topical corticosteroids have not been performed to date.1,17
Pregnancy, Fertility, and Lactation
The teratogenic potential of topical alclometasone dipropionate is not known;22,23 however, potent corticosteroids have been shown to be teratogenic in animals following topical application.1,17 Reproduction studies in rabbits using oral or topical alclometasone dipropionate dosages up to 1.2 g/kg or 0.75 mg/kg, respectively, have shown maternal toxicity, including failure to maintain pregnancy, increased resorptions and decreased litter size, inhibition of weight gain, and death.22 Evidence of fetal harm (e.g., developmental retardation, increased malformations such as flexed paws and cleft palate), possibly secondary to maternal toxicity induced by the drug, was shown in these studies.22 For additional information, see Cautions: Pregnancy, Fertility, and Lactation, in the Topical Corticosteroids General Statement 84:06.
Pharmacokinetics
Absorption
Percutaneous penetration of alclometasone dipropionate varies among individuals14 and can be altered by using different vehicles;1,15,16 percutaneous penetration can be increased by the use of occlusive dressings1,4,16,17 and by inflammation1,17 and/or other diseases of the epidermal barrier (e.g., psoriasis, eczema).1,16,17
Following topical application of alclometasone dipropionate to normal skin, only small amounts of the drug appear to reach the dermis and subsequently the systemic circulation with the usual dosa 4,22 about 3% of the drug reportedly reached systemic circulation during the 8-hour period after a single application of 0.5 g of a 0.05% ointment in healthy individuals with normal skin.1,22,27 However, systemic absorption may be increased when the skin is inflamed or diseased.1
Elimination
Following percutaneous penetration of alclometasone dipropionate, drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids.1,17 (See Pharmacokinetics: Elimination, in the Corticosteroids General Statement 68:04.) Systemic metabolism of alclometasone has not been fully characterized or quantified; in animals, drug that is absorbed following topical application does not accumulate in tissues and is extensively metabolized to polar, unidentified metabolites.22 Following topical application, systemically absorbed alclometasone and its metabolites are excreted in feces via biliary elimination and in urine.1,22
Chemistry and Stability
Chemistry
Alclometasone dipropionate is a synthetic corticosteroid.1,2,12 Alclometasone is the 7α-chloro-16α-methyl derivative of prednisolone.2,6,10,12,19,20,21 Esterification of the hydroxyl group at positions 17 and 21 of the alclometasone molecule enhances the topical anti-inflammatory activity of the dipropionate compared with alclometasone.12,19 Alclometasone dipropionate occurs as a white powder1 and has solubilities of 6.8 and 1.6 mg/mL in alcohol and in propylene glycol, respectively, at 25°C.22 The drug is practically insoluble in water.1,22
Stability
Alclometasone dipropionate cream and ointment should be stored at 2-30°C.1
Additional Information
For further information on chemistry, pharmacology, absorption, uses, cautions, methods of application, and use of occlusive dressings in therapy with alclometasone dipropionate, see the Topical Corticosteroids General Statement 84:06.
AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions January 29, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
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22. Vonderweidt J (Glaxo, Research Triangle Park, NC): Personal communication; 1987 Apr 15.
23. Reviewers' comments (personal observations); 1987 Apr.
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