Topical treatment of moderate scalp psoriasis in adults.

For cutaneous use on the scalp only.
Clobex 500 micrograms/g shampoo should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. An amount equivalent to around a half tablespoon (around 7.5 ml)
per application is sufficient to cover all the scalp. Clobex 500 micrograms/g shampoo should be then kept in place without covering for 15 minutes before rinsing. Hands should be washed carefully after application. After 15 minutes, the product must be rinsed with water and / or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual.
The treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary.
Repeated courses of Clobex 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.

Paediatric population:

Experience in the paediatric population is limited. Clobex 500 micrograms/g shampoo is not recommended for use in children and adolescents below 18 years of age. It is contraindicated in children under 2 years of age (see sections 4.3 and 4.4).

Patients with known hypersensitivity to the active substance or to any of the excipients. Skin areas affected by bacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by syphilis). Clobex 500 micrograms/g shampoo must not be applied to the eye (risk of glaucoma) or to ulcerous wounds. Children under 2 years of age.

Topical corticosteroids should be used with caution for a number of reasons including post treatment rebound relapses, development of tolerance (tachyphylaxis) and development of local or systemic toxicity. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalised pustular psoriasis in case of intensive and prolonged topical use. In very rare cases, hypersensitivity to corticosteroids can be observed. This can be suspected in case of resistance to treatment. 
In general, long-term continuous therapy with corticosteroids, use of occlusive mobcaps or treatment of children can lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients may be evaluated periodically for evidence of HPA axis suppression. Such systemic effects disappear when treatment is stopped. However, abrupt discontinuation can lead to acute adrenal insufficiency, especially in children. Clobex 500 micrograms/g shampoo is required for
use in children and adolescents below 18 years of age, it is recommended that the treatment should be reviewed weekly. 
Clobex 500 micrograms/g shampoo is only intended for the treatment of scalp psoriasis and should not be used to treat other skin areas. In particular, Clobex 500 micrograms/g shampoo is not recommended
for use in the face, eyelids, intertriginous areas axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of topical adverse events such as atrophic changes, telangectasia or cortico-induced dermatitis.
If Clobex 500 micrograms/g shampoo does enter the eye, the affected eye should be rinsed with copious amounts of water.

No interaction studies have been performed.

Pregnancy
There are no adequate data from the use of topical clobetasol propionate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Clobex 500 micrograms/g shampoo should not be used during pregnancy unless clearly necessary.
Breastfeeding
Systemically administered corticosteroids pass into breast milk. Damage to the infant is not reported to date. Nevertheless, as there are no adequate data on the possible milk transfer of topical clobetasol propionate and its biological or clinical repercussions, Clobex 500 micrograms/g shampoo should not be prescribed to breastfeeding women unless clearly indicated.

As a topical corticosteroid, Clobex 500 micrograms/g shampoo has no or negligible influence on the ability to drive and use machines.

During clinical development of Clobex 500 micrograms/g shampoo, in a total of 558 patients receiving Clobex 500 micrograms/g shampoo, the most commonly reported adverse drug reaction was skin discomfort. Its incidence was about 5%. Most adverse events were rated as mild to moderate and they were not affected by race or gender. Clinical signs of irritation were uncommon (0.5%). No serious drug-related adverse events were reported during any of the clinical trials.

If signs of local intolerance appear, application should be suspended until they disappear. If signs of hypersensitivity appear, application should be stopped immediately.
The table below reports the adverse reactions related to treatment by body system and by absolute frequency:

Organ Class	Incidence	Adverse reactions
Skin and subcutaneous tissue disorders.	Common (≥1/100, <1/10) Uncommon (>1/1000, <1/100)	Skin discomfort. Acne/folliculitis Local signs of irritation Pruritus Urticaria Telangiectasia Skin atrophy
Eye disorders	Common (≥1/100, <1/10)	Eye stinging/burning.

 

As a class attribution, prolonged use of topical corticosteroids, treatment of extensive areas or use of large amounts can result in sufficient systemic absorption to produce the features of hypercortisolism (Cushing syndrome) or of Hypothalamus-Pituitary-Adrenal (HPA) axis suppression. Should HPA axis suppression occur, it is likely to be transient with a rapid return to normal values. However, as Clobex 500 micrograms/g shampoo is to be kept in place for only 15 minutes before rinsing, systemic absorption is seldom observed (see section 5.2) and therefore, the risk of appearance of HPA axis suppression is very low compared to non rinsed potent corticosteroids products. No HPA axis suppression has been observed during clinical trials with Clobex 500 micrograms/g shampoo. Prolonged and/or intensive treatment with potent corticosteroid preparations may cause local atrophic changes, such as local skin atrophy, striae, telangiectasia, erythema, purpura, contact dermatitis. When applied to the face, very potent corticosteroids can induce perioral dermatitis, skin atrophy or worsen rosacea. During development of Clobex 500 micrograms/g shampoo, skin atrophy was assessed using ultrasound measurement of skin thickness in a specific clinical trial involving 13 patients. After 4 weeks of treatment with Clobex 500 micrograms/g shampoo, no skin thinning was observed.
There are reports of pigmentation changes, acne, pustular eruptions and hypertrichosis with topical corticosteroids.

Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually. However, because of the risk of acute adrenal suppression, this should be done under
medical supervision.

Pharmacotherapeutic class: CORTICOSTEROIDS, VERY POTENT (Group IV)
ATC Code: D07AD01
Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical corticosteroids in general is unclear. However, corticosteroids are thought to act by 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.

In vitro liberation –penetration studies on human skin showed that only a small percentage (0.1%) of the applied dose of Clobex 500 micrograms/g shampoo can be found in the epidermis (including the
stratum corneum) when applied for 15 minutes and then rinsed. The very low topical absorption of clobetasol propionate from Clobex 500 micrograms/g shampoo when applied according to the recommended clinical use (15 minutes before rinse off) resulted in negligible systemic exposure in animal studies and in clinical trials.
Available clinical data revealed that only 1 of 141 subjects had a quantifiable clobetasol propionate plasma concentration (0.43 ng/ml).
The present pharmacokinetic data indicate that systemic effects following clinical treatment with Clobex 500 micrograms/g shampoo are highly unlikely due to the low systemic bioavailability of clobetasol propionate.

Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single, repeated dose toxicity and genotoxicity. The carcinogenicity of clobetasol has not been studied.
In rabbits, Clobex 500 micrograms/g shampoo was slightly irritating to the skin and eyes, but no delayed-type hypersensitivity was seen on guinea pigs’ skin.
In developmental toxicity studies in rabbits and mice, clobetasol propionate was shown to be teratogenic when administered subcutaneously at low doses In a topical embryotoxicity study of clobetasol. In rats, foetal immaturity and skeletal and visceral malformations were observed at
relatively low dosage levels. In addition to malformations, studies in animals exposed to high systemic levels of glucocorticoids during pregnancy have also shown other effects on the offspring, such as intrauterine growth retardation. The clinical relevance of the effects of clobetasol and other
corticosteroids in developmental animal studies is unknown.

Ethanol 96 percent, coco-alkyl dimethyl betaine, sodium laurethsulfate, polyquaternium-10, sodium citrate, citric acid monohydrate, purified water.

Not applicable.

3 years. Shelf life after first opening: 4 weeks.

Store in the original container.

30 ml, 60 ml, or 125 ml high density polyethylene (HDPE) bottles.
The 30 ml bottle is fitted with a polypropylene screw cap.
The 60 ml and 125 ml bottles are fitted with a clipped polypropylene cap.
1 g of shampoo corresponds to 1 millilitre of shampoo.
Not all pack sizes may be marketed.

No special requirements.