Registration successful
Account activated – pending validation.
Your account has been activated successfully, but we still need to validate you as a healthcare professional. We’ll send you an email with the result of the validation process in the next three days.
In the meantime, you can enjoy access to all the latest news, events and resources for different therapy areas on our website.Clinical evidence
Overview of TCS development
Corticosteroids have been used in medicine since the 1950s. 12 Analogues have since been developed with improved selectivity profiles and potency to limit the adverse effects associated with earlier molecules. 34 Topical corticosteroid treatments are now available in a wide variety of preparations and strengths 5
History of TCS development 6-8
We now have decades of clinical trial and real-world data to inform the use of these well-established treatments for steroid-responsive dermatoses.
Betnovate key clinical trials and real-world data
Betnovate (betamethasone valerate; formulations: cream, ointment, lotion, scalp application, ready- diluted cream, ready-diluted ointment), which was first licensed in 1963, is a potent topical corticosteroid. The effectiveness and safety of betamethasone valerate formulations have been demonstrated in clinical studies and through widespread use for over fifty years.
Clinical trials in atopic dermatitis have shown that:
- Betamethasone valerate is as effective as mometasone furoate in the treatment of a variety of steroid-responsive dermatoses 9
- Betamethasone valerate has favourable cosmetic properties compared with mometasone furoate, which may influence patient compliance 10
Clinical trials in psoriasis have shown that:
- Betamethasone valerate cream is as effective and well tolerated as Cutivate (fluticasone propionate), another mid-potency TCS, for the treatment of moderate-to-severe psoriasis 11
- Betamethasone valerate lotion is as effective as calcipotriol lotion in the treatment of scalp psoriasis 12
Trials in atopic dermatitis
Betamethasone valerate cream is as effective as mometasone furoate in the treatment of a variety of steroid-responsive dermatoses
- Mometasone furoate cream (0.1%) once daily and betamethasone valerate cream (0.1%) twice daily rapidly and progressively reduced the severity of signs and symptoms in 69 patients aged ≥12 years with steroid-responsive dermatoses 9
- Over 21 days, both agents rapidly and progressively provided relief for various dermatoses 9
- More patients in the betamethasone valerate group (47.1%) than in the mometasone furoate group (31.4%) discontinued treatment due to clearance of lesions 9
Betamethasone valerate cream has favourable cosmetic properties compared with mometasone furoate in the treatment of atopic dermatitis, which may influence patient compliance
- Betamethasone valerate cream (0.1%) once daily was superior to mometasone furoate cream (0.1%) once daily for smell, consistency, smearing quality and skin penetration, and was preferred for its overall cosmetic qualities (p≤0.005) in 30 patients aged 15–66 years with atopic dermatitis
- Betamethasone valerate has favourable cosmetic properties to mometasone furoate, which may influence patient compliance 10
Trials in psoriasis
Betamethasone valerate cream is as effective and well tolerated as fluticasone propionate, another mid-potency TCS, for the treatment of moderate-to-severe psoriasis
- Two identical double-blind randomised, parallel-group trials of 350 patients aged 16–89 years with moderate-to-severe psoriasis showed that after 29 days of treatment, 69% of patients treated with betamethasone valerate cream (0.1%) once daily and 64% of patients treated with fluticasone propionate (0.05%) twice daily were rated clear to good (according to the Physician’s Global Assessment) in Study 1; and 67% and 64%, respectively, in Study 2
- Betamethasone valerate can be prescribed for difficult-to-treat patients with moderate-to- severe psoriasis 11
Betamethasone valerate lotion is as effective as calcipotriol lotion in the treatment of scalp
- Betamethasone valerate lotion (1%) twice daily was found to be as effective as calcipotriol lotion in the treatment of scalp psoriasis in 42 patients aged 6–61 years, with fewer adverse effects 12
Psoriasis sign score: thickness, redness and scaliness assessed on a scale of 0 (absent) to 4 (severe)
Cutivate key clinical trials and real-world data
Cutivate (fluticasone propionate; formulations: cream, ointment), a potent corticosteroid received FDA market approval in 2003 for the treatment of steroid responsive dermatoses (SRDs). 13Prior to this, fluticasone propionate was first licensed for use in respiratory therapies in 1994.
Clinical trials in eczema have shown that:
- Fluticasone propionate is therapeutically superior to vehicle and is well tolerated in the treatment of moderate-to-severe eczema 14
- Once-daily application of fluticasone propionate produced relief of long-standing moderate- to-severe eczema comparable to twice daily dosing 1516
Clinical trials in atopic dermatitis have shown that:
- Fluticasone propionate is as well tolerated as a low-potency TCS (hydrocortisone) in paediatric atopic dermatitis 17
- After control of acute flares, extended intermittent fluticasone propionate therapy significantly reduced the risk of relapse in paediatric and adult patients with atopic dermatitis 18
Clinical trials in psoriasis have shown that:
- Fluticasone propionate ointment and cream are therapeutically superior to hydrocortisone in adults with moderate-to-severe psoriasis 1920
Other studies have provided data on fluticasone propionate safety, 1721the use of fluticasone propionate in children, 2223the effect of fluticasone propionate on skin thickness 24and the cosmetic and physiochemical properties of fluticasone propionate compared with other TCSs. 25
Trials in eczema
Fluticasone propionate ointment is therapeutically superior to vehicle and is well tolerated in the treatment of moderate-to-severe eczema
- Treatment of moderate-to-severe eczema with fluticasone propionate ointment (0.005%) twice daily for 4 weeks was significantly superior to vehicle in 1,203 patients aged 12–84 years with moderate-to-severe eczema at all post-baseline visits (p=0.0001)
- Twice-daily application of fluticasone propionate ointment (0.005%) for up to 4 consecutive weeks was found to be safe and effective for the treatment of moderate-to-severe eczema 14
Once-daily application of fluticasone propionate cream produced relief of long-standing moderate- to-severe eczema comparable to twice daily dosing
The efficacy and safety of fluticasone propionate cream (0.05%) applied once-daily over 4 weeks was comparable to twice daily application in the treatment of 238 patients ≥12 years old with moderate-to-severe eczema 1516
Trials in atopic dermatitis
Fluticasone propionate cream is as well tolerated as a low-potency TCS (hydrocortisone) in paediatric atopic dermatitis
- Fluticasone propionate cream (0.05%) twice daily is more effective than hydrocortisone cream (HC, 1%) against acute (2–4 week; p< 0.001) and longer-term (12 weeks; p=0.006) moderate-to-severe atopic dermatitis in children aged 2–14 years, with equivalent tolerability
- Fluticasone propionate was well tolerated, with no visible signs of skin atrophy 17
Extended intermittent fluticasone propionate cream therapy significantly reduced the risk of relapse in paediatric and adult patients with atopic dermatitis
- After stabilisation, twice-weekly treatment with fluticasone propionate cream (0.05%) significantly reduced the risk of relapse (p≤0.001 compared with vehicle base) in children and adults with atopic dermatitis 18
- The risk of relapse was 7.7 times lower in the fluticasone propionate group compared with the vehicle group (p≤0.001)
Trials in psoriasis
Fluticasone propionate ointment and cream are therapeutically superior to hydrocortisone in adults with moderate-to-severe psoriasis
- According to the Physician’s Global Assessment, twice daily fluticasone propionate ointment and cream (0.005%) were therapeutically superior to hydrocortisone (0.1%, ointment p=0.007 and cream p≤0.05) in 113 adults aged 18–84 years with moderate-to-severe psoriasis 1920
- Patients favoured fluticasone propionate (p≤0.05) after 3–4 weeks of treatment 19
| Common ≥ 1/100 and < 1/10 |
Uncommon ≥ 1/1000 and < 1/100 |
Very rare < 1/10000 |
|
|
|
Fluticasone propionate cream or lotion is well tolerated as a treatment of atopic dermatitis in infants from 3 months of age
- Results from two studies show that treatment of moderate-to-severe or extensive atopic dermatitis in infants aged 3 months to 5 years with fluticasone propionate cream (0.05%) or lotion (0.05%) twice daily for 3–4 weeks had no clinically significant effects on the HPA axis (determined by adrenal response to cosyntropin) 2223
Additional studies
Fluticasone propionate cream has no significant effect on skin thickness after 8 weeks of treatment
- Fluticasone propionate cream (0.05%) once daily over 2–8 weeks* in 40 healthy volunteers aged 18–65 years caused a mean 3% decrease in skin thickness compared with placebo, independent of treatment duration 24
- For groups receiving 2, 4, 6 and 8 weeks of treatment, there was insufficient evidence to claim that the length of treatment influences skin thickness (P=0.088). This was also true of the values obtained at the end of the 8-week post-treatment follow-up 24
*Fluticasone propionate is licensed for use 1–2 times/day for up to 4 weeks; thereafter it can be used as a once-daily application, twice weekly, without occlusion for maintenance treatment
Fluticasone propionate has the most favourable cosmetic and physiochemical properties compared with six other topical corticosteroids
- Fluticasone propionate was rated best out of six topical corticosteroids in terms of cosmetic and physicochemical properties 25
Dermovate key clinical trials and real-world data
Dermovate (clobetasol propionate; formulation: cream, ointment, scalp application) was approved in the mid-1980s 6and is a super potent TCS which is used to treat more resistant steroid-responsive dermatoses.
Clinical trials in eczema have shown that:
- Clobetasol propionate cream is more effective than mometasone furoate cream in the treatment of moderate-to-severe chronic eczema 26
Clinical trials in psoriasis have shown that:
- Significantly more patients with psoriasis showed greater improvement with clobetasol propionate ointment than with betamethasone dipropionate ointment 27
Clinical trials in scalp psoriasis have shown that:
- Clobetasol propionate solution is superior to betamethasone dipropionate solution in patients with scalp psoriasis 28
- Clobetasol propionate solution and augmented betamethasone dipropionate lotion are equally effective in the treatment of moderate-to-severe scalp psoriasis 29 30
Other studies have provided data on clobetasol propionate safety 31 and patient and physician treatment preference. 32
Trials in eczema
Clobetasol propionate cream is more effective than mometasone furoate cream in the treatment of moderate-to-severe chronic eczema
- After 3 weeks of treatment, clobetasol propionate cream (0.05%) twice daily showed significantly greater efficacy than mometasone furoate cream (0.1%) in patients aged 16–85 years with moderate-to-severe chronic eczema 26
Trials in psoriasis
Significantly more patients with psoriasis showed greater improvement with clobetasol propionate ointment than with betamethasone dipropionate ointment
- In 130 patients with psoriasis treated twice daily for 2 weeks, improvement was greater with clobetasol propionate ointment (0.05%) than with optimised betamethasone dipropionate ointment (0.05%) 27
Trials in scalp psoriasis
Clobetasol propionate solution is superior to betamethasone dipropionate solution in patients with scalp psoriasis
- In 40 patients aged ≥15 years with moderate-to-severe scalp psoriasis treated twice daily for 2 weeks, clobetasol propionate solution (0.05%) was superior to betamethasone dipropionate solution (0.05%) in reducing scaling, induration, erythema and itching 28
Clobetasol propionate solution and augmented betamethasone dipropionate lotion are equally effective in the treatment of moderate-to-severe scalp psoriasis
* Scale: 0=none; 1=mild; 2=moderate; 3=severe
Safety studies
The potential for local and systemic adverse effects is higher with clobetasol propionate (a super- potent TCS) than with agents of lower potency
Common, uncommon and very rare adverse effects are reported below: 31
| Common ≥ 1/100 and < 1/10 |
Uncommon ≥ 1/1000 and < 1/100 |
Very rare < 1/10000 |
|
|
|
Additional studies
Treatment preference
Patients and physicians prefer clobetasol propionate ointment over diflorasone diacetate in the treatment of moderate-to-severe psoriasis.
- In a 2-week trial, clobetasol propionate ointment (0.05%) twice daily was preferred over diflorasone diacetate (0.05%) twice daily by both patients and physicians for the treatment of moderate-to-severe psoriasis 32
Eumovate key clinical trials and real-world data
Eumovate (clobetasone 17-butyrate; formulation: cream, ointment) is a moderately potent topical corticosteroid for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses (SRDs).
Clinical trials in eczema have shown that:
- Clobetasone butyrate cream is more effective than hydrocortisone cream for the treatment of eczema 33
Clinical trials in contact dermatitis have shown that:
- Clobetasone butyrate cream is a more effective anti-inflammatory agent with better moisturising properties than hydrocortisone cream for nickel-induced contact dermatitis 34
Other studies have provided data on clobetasone butyrate safety 35as well as a review of 29 clinical trials and post-marketing studies. 36
Trials in eczema
Clobetasone butyrate cream is more effective than hydrocortisone cream for the treatment
- Clobetasone butyrate cream (0.01%) was significantly more effective than HC cream (1%) (p<0.05) for the treatment of 409 children and adults with eczema 33
Trials in contact dermatitis
Clobetasone butyrate cream is a more effective anti-inflammatory agent with better moisturising properties than hydrocortisone cream for nickel-induced contact dermatitis
- Clobetasone butyrate cream (0.05% in an emollient base containing 25%w/w glycerol*) twice daily induced a significantly greater response and had better moisturising properties than hydrocortisone cream (1% ) in 18 adult patients with nickel-induced contact dermatitis 34
*Although the emollient base in clobetasone butyrate cream contains glycerol, moisturisers/emollients are still required
Safety studies
Clobetasone butyrate cream offers clinically effective topical anti-inflammatory activity with a wide margin of safety
- Clobetasone butyrate cream (0.05%) twice daily significantly improved clinical symptoms of atopic dermatitis in children aged 4 months – ≤15 years with chronic atopic dermatitis after 1 and 2 weeks of treatment (p<0.01) 35
- Plasma cortisol and ACTH concentrations remained within the normal range and circadian variation was maintained 35
Additional studies
Clinical trials review
Clobetasone butyrate cream is an effective treatment for the management of eczema and dermatitis in clinical practice
- A review of the key efficacy and safety data from 29 clinical trials and post-licensing pharmacovigilance safety information in patients with eczema or psoriasis36 showed that clobetasone butyrate (0.05%) was more effective than:
- Hydrocortisone 1% in the treatment of eczema
- Flurandrenolone (0.0125%) (p=0.01%) and hydrocortisone butyrate (p<0.05) in the treatment of psoriasis
- Hydrocortisone 1% in the treatment of eczema
- Clobetasone butyrate (0.05%) had a minimal effect on skin thickness as assessed by radiography 36
References:
- FDA: Recommendations regarding the safety and efficacy of hydrocortisone (1979). Available at: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4099B1_02_FDA-Tab2.pdf (Last accessed October 2014)
- Quirke V. Stud Hist Phil Biol and Biomed Sci 2005; 36:645–74
- Johnson M. J Allergy Clin Immunol 1998; 101:S434–39
- Morley KW, et al. Curr Opin Pediatr 2012; 24:121–28
- Eichenfield LF, et al. J Am Acad Dermatol 2014; 71:116–32
- Weaver J. Department of Health and Human Services. Memorandum 2001
- GSK: Our History. Available at: http://www.gsk.com/en-gb/about-us/our-history (Last accessed August 2015)
- MHRA Public Assessment Report. Clobetasone butyrate (July 2015). Available at: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con566810.pdf (Last accessed August 2015)
- Viglioglia P, et al. J Int Med Res 1990;18:460–67
- Reidhav I, et al. J Dermatol Treat 1996;7:87–88
- Callen J. Cutis 1996;56:45–50
- Duweb GA, et al. Int J Clin Pharmacol Res 2000;20:65–68
- FDA Listing of Authorized Generics as of October 31st 2014. Available at: http://www.fda.gov/downloads/aboutfda/centersoffices/cder/ucm183605.pdf (Last accessed Nov 2014)
- Lebwohl M. Cutis 1996;57:62–8
- Tharp MD. Cutis 1996;57:19–26
- Bleehen SS, et al. Br J Dermatol 1995;133:592–7
- Kirkup M, et al. J Dermatol Treat 2003;14:141–8
- Hanifin J, et al. Br J Dermatol 2002;147:528–37
- Nurnberger FG. Cutis 1996;57:39–44
- James M. Cutis 2001;67:2–9
- Stiefel: Flucticasone propionate Global Data Sheet (15th February 2011)
- Friedlander SF, et al. J Am Acad Dermatol 2002;46:387–93
- Hebert AA, et al. J Pediatr 2006;149:378–82
- Dykes PJ, et al. Clin Exp Derm 1996; 21:180–4
- Hadzija BW, Ambrose WW. Cutis 1996;57:13–18
- Goh CL, et al. SMJ 1999;40:241–245
- Jacobson C, et al. Cutis 1986;37:213–220
- Lassus A. Curr Med Res Opin 1976;4:365–367
- Katz HI, et al. Clin Therapeutics 1995;17:390–401
- Jarratt M, et al. Advances in Therapy 1991;8:103–111
- Stiefel: Clobetasol propionate Global Data Sheet (23rd August 2013)
- Jegasothy BV. Int J Dermatol 1990;29:729–730
- Munro D, et al. Br Med J 1975;3:626–8
- Parneix-Spake A, et al. J Dermatol Treat 2001;12:191–7
- Boner AL, et al. Int J Clin Pharmacol Ther Tox 1985;23:118–20
- Goustas P, et al. J Dermatol Treat 2003;14:71–85
Cutivate, Betnovate, Dermovate and, Eumovate are registered trademarks of Stiefel, a GSK company.
Copyright © 2015 Stiefel, a GSK company.
