clobetasol and Adrenal-Insufficiency

Clobetasol propionate 0.05% emulsion foam was recently developed for use on multiple body sites.. We sought to evaluate safety and efficacy of clobetasol emulsion foam 0.05% to treat steroid-responsive dermatoses in multiple age groups.. A phase II open-label study evaluated the effect of clobetasol foam on the hypothalamic-pituitary-adrenal axis in 52 participants aged 6 years or older with mild-to-severe atopic dermatitis (AD). Cosyntropin stimulation test was used to determine the effect of clobetasol foam on hypothalamic-pituitary-adrenal axis, with a normal response considered to be a postinjection serum cortisol level greater than 18 mug/dL. Another phase II open-label pharmacokinetic safety study was conducted in 32 participants aged 12 years or older with mild-to-moderate plaque-type psoriasis. Pharmacokinetic parameters evaluated included maximal plasma concentration of clobetasol propionate, time to achieve maximum concentration, and area under the curve. Two phase III, randomized controlled studies assessed treatment success in participants aged 12 years or older with moderate-to-severe AD (N = 377) or mild-to-moderate plaque-type psoriasis (N = 497). In all studies, participants received study drug for 2 weeks. In the AD study, treatment success was determined using a composite end point requiring an Investigator's Static Global Assessment (ISGA) score of 0 or 1, erythema score of 0 or 1, induration/papulation score of 0 or 1, and improvement in the ISGA score of at least two grades from baseline. Likewise, the study in plaque-type psoriasis used a composite end point requiring an ISGA score of 0 or 1, erythema score of 0 or 1, scaling score of 0 or 1, plaque thickness score of 0, and improvement in the ISGA score of at least two grades from baseline.. Significantly more participants achieved treatment success on clobetasol foam than vehicle foam (P < .0001 and P = .0005 for each study). Reversible hypothalamic-pituitary-adrenal axis suppression was observed in 27% of participants aged 18 years or older and 47% in participants aged between 6 and younger than 12 years, but 0% in participants aged between 12 and younger than 18 years.. The studies evaluated short-term use only.. Clobetasol emulsion formulation foam is safe and effective for treatment of moderate-to-severe AD and mild-to-moderate plaque-type psoriasis in patients aged 12 years or older.

Topics: Administration, Cutaneous; Adolescent; Adrenal Insufficiency; Adult; Age Factors; Aged; Area Under Curve; Biological Availability; Child; Clobetasol; Cosyntropin; Dermatitis, Atopic; Emulsions; Humans; Hydrocortisone; Immunosuppressive Agents; Middle Aged; Pituitary-Adrenal Function Tests; Psoriasis; Treatment Outcome

Topics: Administration, Topical; Adrenal Insufficiency; Anti-Inflammatory Agents; Betamethasone; Clinical Trials as Topic; Clobetasol; Costs and Cost Analysis; Glucocorticoids; Humans; Psoriasis; Skin Diseases

Topics: Administration, Topical; Adrenal Insufficiency; Betamethasone; Clobetasol; Humans

Percutaneous absorption of topically applied 0.05% clobetasol propionate (CLO) can be assessed indirectly by measuring cortisol levels. A direct way is to measure systemic levels of topically applied CLO.. Serum concentrations of CLO were measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS), and were related to serum cortisol levels in 25 patients with an exacerbation of atopic dermatitis (AD) before and after the first day of treatment with 0.05% CLO in hospital. The body surface area (BSA) affected by AD was measured.. Before the start of 0.05% CLO treatment, normal cortisol levels were measured (0.47 ± 0.18 μmol/l) and CLO concentrations could not be detected. After the first day of treatment, cortisol levels decreased to 0.04 ± 0.05 μmol/l. Serum concentrations of CLO could be detected in all patients (0.112-4.504 ng/ml). Levels did not differ between patients who had received two applications versus one application of 0.05% CLO. There was no correlation between the affected BSA and serum concentrations of CLO.. Serum levels of CLO can be measured by LC/MS/MS. When prescribing 0.05% CLO, one must bear in mind that, even after an application of 20-30 g, CLO is systemically available and potent enough to induce adrenal gland suppression.

Topics: Adolescent; Adrenal Glands; Adrenal Insufficiency; Adult; Aged; Anti-Inflammatory Agents; Clobetasol; Dermatitis, Atopic; Female; Humans; Hydrocortisone; Male; Middle Aged; Young Adult

A 59-year-old Caucasian gentleman presented with malaise, fatigue and proximal muscle weakness. He had history of long-standing roseate psoriasis treated with topical clobetasol propionate (dermovate). On admission, he had significant postural hypotension, and hypercalcaemia. Endocrinological investigation revealed hypercalcaemia, a serum cortisol of <30 nmol/l, a flat short synacthen test and undetectable adrenocorticotropic hormone. He was treated with hydrocortisone. The abrupt withdrawal of the topical steroids by the patient precipitated the addisonian crisis. Further enquiry documented inappropriate oral administration of clobetasol for more than 10 years in addition to prescribed topical usage.

Topics: Adrenal Insufficiency; Clobetasol; Glucocorticoids; Humans; Hydrocortisone; Hypercalcemia; Male; Middle Aged; Psoriasis; Self Medication

Prolonged application of topical steroids transiently suppresses the hypothalamic-pituitary-adrenal axis (HPA). Infants who are exposed to topical corticosteroids have greater risk for Cushing's syndrome or adrenocortical insufficiency caused by suppression of the HPA axis because glucocorticoids are highly absorbed through the diaper area. Here, we report six infants (four girls, two boys) aged between 3 and 8 months who were exposed to potent topical corticosteroids (clobetasol propionate and diflucortolone valerate) by the mother's application without prescription.. We examined the HPA axis and other side effects of the potent glucocorticoid therapy in these infants. After stopping the topical corticosteroid, serum AST, ALT, lipids, morning cortisol and ACTH levels were measured. A low dose ACTH stimulation test was carried out. Hydrocortisone was started for the prevention of glucocorticoid withdrawal syndrome and the dose was gradually decreased. Abdominal ultrasonography was performed to investigate hepatosteatosis.. The ACTH stimulation test showed suppression of the HPA axis in these infants. Hepatomegaly was found in all infants and three of them had hepatosteatosis. Liver transaminase levels were elevated in five infants. Five patients have been followed for 6-14 months. One infant died due to generalized Cytomegalovirus infection.. We emphasize that physicians should be alert for the dangerous side-effects of topical steroids and they should avoid long-term use. Furthermore, parents should be informed about the side-effects when topical steroid treatment is chosen.

Topics: Administration, Topical; Adrenal Insufficiency; Adrenocorticotropic Hormone; Anti-Inflammatory Agents; Clinical Chemistry Tests; Clobetasol; Contraindications; Cushing Syndrome; Diaper Rash; Diflucortolone; Drug Overdose; Fatal Outcome; Female; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Infant; Male; Pituitary-Adrenal System

Complications caused by skin lightening practices have not been systematically studied in Europe.. Our aim was to assess the complications of skin lightening among people of African descent living in Paris.. This was a descriptive study. All patients presenting with complications from skin lightening procedures underwent a complete clinical examination and were questioned about their practice.. Forty-six patients from various African countries (39 women, 7 men) presented with skin changes suggestive of side effects from skin lightening practices. The complications seemed mainly related to the use of clobetasol and hydroquinone.. The selection bias does not allow assessment of uncomplicated skin lightening.. Complications arising from skin lightening practices represent a significant health problem for people of African descent living in Paris.

Topics: Adrenal Insufficiency; Adult; Africa; Black People; Clobetasol; Cosmetics; Female; Glucocorticoids; Humans; Hydroquinones; Male; Middle Aged; Paris; Skin Diseases; Skin Pigmentation

A 72-year-old woman developed manifestations of Cushing's syndrome after long-term topical steroid therapy for psoriasis. Shortly after tapering the dose of topical steroids she developed signs of adrenal insufficiency (provoked by a urinary tract infection) requiring intravenous administration of a stress dose of hydrocortisone. There have only been a few reports of systemic side effects of topically applied corticosteroids in adults. Considering their serious consequences physicians should be alert to signs of Cushing's syndrome in patients on long-term topical steroid therapy. Furthermore, clobetasol propionate ointment doses exceeding 50 g a week should not be prescribed and use of occlusive dressings should be avoided.

Topics: Administration, Topical; Adrenal Insufficiency; Aged; Anti-Inflammatory Agents; Clobetasol; Cushing Syndrome; Female; Glucocorticoids; Humans; Psoriasis

A 53-year-old man with cushingoid appearance--obesity, osteoporosis causing lumbar and thoracic vertebral collapse and a past history of hypertension and depression presented with symptoms and signs of adrenocortical insufficiency. He denied the use of corticosteroid medication. However, it was eventually discovered that he had used clobetasol propionate (Dermovate), a potent topical steroid cream, for five years. The development of adrenal insufficiency symptoms coincided with the withdrawal of the cream.

Topics: Adrenal Insufficiency; Clobetasol; Cushing Syndrome; Humans; Male; Middle Aged; Time Factors

Topics: Administration, Topical; Adrenal Insufficiency; Betamethasone; Clobetasol; Humans

The use of topical steroids is associated with adverse systemic effects such as suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and application of more than 50 g per week of clobetasol propionate cream has been shown to cause secondary adrenal failure. We describe 4 patients who used clobetasol propionate cream over a prolonged period; 3 patients used less than 50 g per week (7.5, 25 and 30 g per week) and yet all developed secondary adrenal failure for up to 4 months after cessation of therapy. Adrenal insufficiency following prolonged use of clobetasol propionate in moderate dosages may therefore be more common than previously recognized. It is suggested that the metyrapone test, which conveniently examines the entire HPA axis, should be employed in patients receiving long-term topical clobetasol propionate cream and that glucocorticoid supplementation should be given during episodes of stress, such as infections and surgery, for up to 4 months after cessation of therapy.

Topics: Administration, Topical; Adrenal Glands; Adrenal Insufficiency; Adult; Aged; Betamethasone; Clobetasol; Depression, Chemical; Female; Humans; Male; Middle Aged; Psoriasis

Topics: Adrenal Insufficiency; Amniotic Fluid; Androstanes; Chromatography, Gas; Clobetasol; Female; Fetal Blood; Humans; Infant, Newborn; Placenta; Placenta Diseases; Pregnancy; Pregnanes; Sulfatases