Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Dermovate Scalp Application
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Clobetasol propionate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Dermovate Scalp Application (called 'Dermovate' in this leaflet) contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Dermovate is used to help reduce the redness and itchiness of certain scalp problems. These include frequently relapsing dermatoses and psoriasis that have not responded to milder steroid creams, ointments, lotions or scalp applications.
2.
What you need to know before you take it
e Dermovate
Do not use Dermovate:
- if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine (listed in Section 6)
- if you have a skin infection on your scalp
- on a child under 1 year of age. Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Dermovate. Warnings and precautions Talk to your doctor or pharmacist before using your medicine if:
- you experience newly developed bone pain or worsening of previous bone symptoms during a treatment with Dermovate especially if you have been using Dermovate for a prolonged time or repeatedly.
- you use other oral/topical medication containing corticosteroids or medication intended to control your immune system (e.g. for autoimmune disease or after a transplantation). Combining Dermovate with these medicines may result in serious infections.
• •
• • • •
you have previously had an allergic reaction with another steroid. you are applying the liquid under an airtight dressing. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much. Do not bandage or otherwise cover the treated scalp area, unless directed to do so by your doctor. If directed to cover the treated area with a dressing, make sure that the skin is cleansed before a fresh dressing is applied to prevent infections. you have psoriasis, your doctor will want to see you more often. you are applying the liquid to broken, damaged or thin skin. you are applying to a large surface area.
Contact your doctor if you experience blurred vision or other visual disturbances. If an infection develops during the use of this medicine talk to your doctor or pharmacist. Be very careful not to get the liquid in your eyes. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine. Children
- Do not use this medicine on a child under the age of 1 year.
- Avoid continuous treatment for a long period of time in children over the age of 1 year, as their skin is thinner than adults and as a result may absorb larger amounts.
- Use on children should be limited to a few days and reviewed weekly.
- Dressings or bandages should not be used on children where the scalp application is applied. Other medicines and Dermovate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially if you are taking ritonavir and itraconazole medications. Pregnancy, breast-feeding and fertility If you are pregnant or are breast-feeding, think you may become pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine
3.
How to take it
Dermovate
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using this medicine
- You usually put Dermovate on your scalp in the morning and at night. This may be reduced as your scalp problem begins to get better, or stopped when it is better.
• • •
• • • • •
For use on your skin of your scalp only. Do not use it more often than prescribed or use it for a long time (such as every day for many weeks or months). If you need treatment for a long time, your doctor may decide you need to use a milder treatment. The germs that cause infections like warm and moist conditions under dressings. If directed to cover the treated area with a dressing, always clean the skin before a fresh dressing is put on to help prevent infection of the skin beneath the dressing. Be very careful not to get the liquid in your eyes. Do not touch your eyes until you have washed your hands. If you wash or shampoo your hair it should be dried before applying the liquid. If you are applying the scalp application on someone else make sure you wash your hands after use or wear disposable plastic gloves. This product is flammable. Keep the liquid away from open fire and flames and all sources of ignition, including smoking, during application and immediately after you've used it. Do not dry your hair with a hairdryer.
Guidance on how to apply the liquid 1 Wash your hands. 2 Unscrew the bottle cap and place the nozzle directly on the scalp that needs treating. 3 Gently squeeze the bottle to cover the area with a thin and even layer of liquid. 4 You can rub this liquid in, but you don't have to. Your scalp will feel cool until the liquid has dried. 5 Wash your hands again. 6 Do not exceed the prescribed amount. Use in children
- Do not use this medicine on children under 1 year of age.
- It is especially important in children not to exceed the prescribed amount.
- A course of treatment for a child should not normally last more than a few days, unless your doctor has told you to use it for longer. The doctor may want to see the child every week whilst using Dermovate scalp application. If you use more Dermovate than you should If you apply too much or if accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible. If you forget to use Dermovate If you forget to apply your scalp application, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time. Do not apply extra Dermovate to make up for a missed dose. If you stop using Dermovate If you use Dermovate regularly make sure you talk to your doctor before you stop using it as your condition may get worse if stopped suddenly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Dermovate and tell your doctor immediately if:
- you find that your scalp problem gets worse, you develop a generalised rash or your skin becomes swollen during treatment. You may be allergic to the scalp application, have an infection or need other treatment.
- you have psoriasis and get raised bumps with pus under the skin. This can happen during or after the treatment and is known as pustular psoriasis. Other side effects you may notice when using Dermovate include: Common (may affect up to 1 in 10 people)
- a feeling of burning, pain, irritation or itching where the scalp application is applied. Uncommon (may affect up to 1 in 100 people)
- skin thinning, this may cause stretch marks
- blood vessels under the surface of your skin may become more noticeable. Very Rare (may affect up to 1 in 10,000 people) Use of Dermovate for a long period of time, or use under an airtight dressing, may cause the following symptoms:
- increased weight
- moon face, rounding of the face
- obesity
- skin thinning
- skin wrinkling
- skin dryness
- changes to the colour of your skin
- increased body hair
- hair loss/lack of hair growth/damaged looking hair Other very rare skin reactions that may occur are:
- allergic reaction at the site of application
- worsening of condition
- application site irritation/pain
- redness
- rash or hives
- if you have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis
- skin infection
- acne In children, also look out for the following symptoms:
- delayed weight gain
- slow growth
Very rare side effects that may show up in blood tests or when your doctor gives you a medical examination:
- a decrease in the level of the hormone cortisol in your blood
- increased levels of sugar in your blood or urine
- high blood pressure
- cloudy lens in the eye (cataract)
- increased pressure in the eye (glaucoma)
- vision problems caused by detachment of the retina in the eye (central serous chorioretinopathy)
- weakening of the bones through gradual loss of mineral (osteoporosis);
- additional tests may be needed after your medical examination to confirm if you have this condition Not Known (frequency cannot be estimated from the available data)
- blurred vision Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Dermovate Scalp Application is classed as a very strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. • • • • • •
6.
How to store it
Dermovate Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle label or carton after (EXP). The expiry date refers to the last day of that month. Do not store above 30°C. Do not use this bottle for more than 3 months after first opening it. Keep the container tightly closed when not in use. Contents are flammable. Keep away from all sources of fire, flame and heat. Do not leave in direct sunlight. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Dermovate contains
• •
The active ingredient is clobetasol propionate. Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w). The other ingredients are carbomer, isopropyl alcohol, sodium hydroxide and purified water
What Dermovate looks like and contents of the pack Within each carton is a specially designed plastic bottle with a nozzle and cap that contains 30 or 100 ml of a sticky liquid. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Glaxo Wellcome UK Ltd, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK Manufacturer: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany More Information If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. You may be able to find out more information from books in public libraries. Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only) Please be ready to give the following information: Product name Dermovate Scalp Application Reference number 10949/0046 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in April 2024. Trade marks are owned by or licensed to the GSK group of companies. © 2024 GSK group of companies or its licensor.
Frequently asked questions about Dermovate Scalp Application
What is the active substance in Dermovate Scalp Application?
The active substance in Dermovate Scalp Application is clobetasol propionate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Dermovate Scalp Application, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Dermovate Scalp Application without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: clobetasol propionate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Clobetasol propionate is a very potent topical corticosteroid which is indicated for use in short courses for conditions which do not respond satisfactorily to less active steroids.
It is indicated for use in steroid responsive dermatoses of the scalp such as:
- Psoriasis
- Recalcitrant dermatoses.
4.2. Posology and method of administration
Clobetasol propionate belongs to the most potent class of topical corticosteroids (Group IV) and prolonged use may result in serious undesirable effects (see section 4.4). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations (see details below).
Route of administration: Topical, on the scalp.
Owing to the flammable nature of the product, Dermovate Scalp Application should be kept away from open fire and flames and all sources of ignition, including smoking, during and immediately after use.
Adults, Elderly and Children over 1 year
A small quantity of clobetasol should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.
Paediatric population
Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.
Care should be taken when using clobetasol propionate to ensure the amount applied is the minimum that provides therapeutic benefit.
Duration of treatment for children and infants
Courses should be limited if possible to a few days and reviewed weekly.
Elderly
Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal / Hepatic Impairment
In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
4.3. Contraindications
Infections of the scalp.
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Dermatoses in children under one year of age, including dermatitis.
4.4. Special warnings and precautions for use
Cases of osteonecrosis serious infections (including necrotizing fasciitis) and systemic immunosuppression (sometimes resulting in reversible Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol propionate beyond the recommended doses (see section 4.2). In some cases patients used concomitantly other potent oral/topical corticosteroids or immunosuppressors (e.g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered.
Care must be taken to keep the preparation away from the eyes.
Patients should be advised to avoid:
• smoking whilst applying to the scalp
• fire, flame and heat including use of hair dryer after application
Clobetasol should be used with caution in patients with a history of local hypersensitivity to other corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see section 4.8) may resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see section 4.8).
Risk factors for increased systemic effects are:
• Potency and formulation of topical steroid
• Duration of exposure
• Application to a large surface area
• Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings)
• Increasing hydration of the stratum corneum
• Use on thin skin areas
• Use on broken skin or other conditions where the skin barrier may be impaired
• In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
Paediatric population
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Children are more susceptible to develop atrophic changes with the use of topical corticosteroids.
Duration of treatment for children and infants
Courses should be limited if possible to a few days and reviewed weekly.
Infection risk with occlusion
Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in Psoriasis
Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.
Visual disturbance
Visual disturbance has been reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Concomitant infection
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
The label will state very strong steroid.
4.5. Interaction with other medicinal products and other forms of interaction
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited data from the use of clobetasol in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see section 5.3)
The relevance of this finding to humans has not been established. Administration of clobetasol during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.
Breast-feeding
The safe use of topical corticosteroids during lactation has not been established.
It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Administration of clobetasol during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation clobetasol should not be applied to the breasts to avoid accidental ingestion by the infant.
Fertility
There are no data in humans to evaluate the effect of topical corticosteroids on fertility
Clobetasol administered subcutaneously to rats had no effect upon mating performance; however, fertility was decreased at the highest dose (see section 5.3).
4.7. Effects on ability to drive and use machines
There have been no studies to investigate the effect of clobetasol on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical clobetasol.
4.8. Undesirable effects
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Post-marketing data
Infections and Infestations
Very rare
Opportunistic infection
Immune System Disorders
Very rare
Hypersensitivity, generalised rash
Endocrine Disorders
Very rare
Hypothalamic-pituitary adrenal (HPA) axis suppression:
Cushingoid features: (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycaemia/glucosuria, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis
Skin and Subcutaneous Tissue Disorders
Common
Pruritus, local skin burning /skin pain
Uncommon
Skin atrophy*, striae*, telangiectasias*
Very rare
Skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
General Disorders and Administration Site Conditions
Very rare
Application site irritation/pain
Eye disorders
Very rare
Cataract, central serous chorioretinopathy, glaucoma
Not known
(cannot be estimated from available data)
Vision, blurred (see also section 4.4)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the risk/benefit balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur (see section 4.8).
Management
In the event of overdose, clobetasol should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- CLOBETASOL MK 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
- CLOBETAZOL ATB 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
- INFILEA 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
- INFILEA 500 µg/g prescriptionCLOBETASOLUM · skin / topical
- DERMOVATE 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Clobetasol propionate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Dermovate partial — not the same combinationClobetasoli propionas · skin / topical
- Clobederm partial — not the same combinationClobetasoli propionas
- Novate partial — not the same combinationClobetasoli propionas
- Clobex partial — not the same combinationClobetasoli propionas
- Clarelux partial — not the same combinationClobetasoli propionas
- Clobetaxon partial — not the same combinationClobetasoli propionas · skin / topical
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Dermovate Scalp Application. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.