NIHR Signal Topical steroids better than vitamin D for treating scalp psoriasis

Published on 14 June 2016

Topical steroids applied to the scalp were more effective and safer for treating psoriasis than topical vitamin D alone.

Using steroids in combination with vitamin D was statistically better than using a steroid alone, but the difference was not considered clinically important. The combination ointment costs almost £20 for 30g compared to a 30g tube of typical steroid ointment which costs about £4.

Scalp psoriasis is a common condition that can be itchy and embarrassing for many. A variety of topical lotions, solutions or gels are available to treat the condition, so this review of published research aimed to help doctors and patients find out which was the most effective and safest option.

This systematic review found 59 trials mainly of steroids or vitamin D, alone or in combination, lasting less than six months. Just over half were known to be sponsored by the manufacturers of the products. This could mean that the results may be biased towards the publication of positive results. Another limitation is that the results are relevant to short term, less than 6 month use only.

The results are in line with current NICE guidelines, which recommend topical steroids alone first-line in different formulations and, if that doesn’t work, a combination of steroid and vitamin D.

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Why was this study needed?

Psoriasis is a common condition affecting around two in every 100 people in Western Europe and the US. The vast majority of people with psoriasis have it affect their scalp causing red patches of skin covered in thick silvery-white scales.

These scaly lesions are visible and can cause embarrassment. Scalp psoriasis can also be extremely itchy, although some people have no discomfort. In extreme cases it can cause hair loss, although this is usually only temporary.

Topical treatments (creams and ointments for the skin) such as corticosteroids (steroids) and vitamin D are usually the first treatments tried, but applying them to the scalp is difficult because of hair on the head. It is also not clear which works best.

This study aimed to help doctors and patients decide which of the wide variety of topical treatments available work best, and the type and frequency of any side effects.

What did this study do?

This Cochrane systematic review included 59 randomised controlled trials of 11,561 participants up to August 2015. All ages were included.

The main outcomes of interest were ‘clearance’ or ‘response’ of psoriasis as assessed by a doctor or the patient themselves using ratings of whether scalp lesions had improved or cleared up completely. Adverse events requiring stopping of treatment, such as allergic reactions, were also recorded.

Three main comparisons of topical treatments were made: topical steroid alone versus vitamin D alone; combination therapy (corticosteroid and vitamin D therapy) versus steroid alone; combination therapy versus vitamin D alone.

Trials concerning these three outcomes were rated as moderate or high quality, most lasted less than six months, and around half were carried out or sponsored by the manufacturer of the study medication. Sponsor involvement can bias results – in this case they can be more likely to find differences where there are none, or discover differences that are artificially large.

What did it find?

  • Patient-rated treatment response using steroids alone was 48% better than those on vitamin D only (Relative Risk [RR], 1.48% 95%CI 1.28 to 1.72). This meant around five patients would need to be treated with steroids to achieve one extra patient who rates themselves as having “responded” to treatment. Steroids in combination with vitamin D were 13% better than vitamin D alone meaning around 13 people would need to be treated for one extra person to benefit in the same way – a difference not considered to be clinically important.
  • Patients and doctors gave similar ratings of improvements.
  • Participants who applied vitamin D alone stopped treatment more often because of adverse effects than those who applied a topical steroid alone or in combination with vitamin D. (RR 0.70, 95% CI 0.58 to 0.85).

What does current guidance say on this issue?

For initial treatment of scalp psoriasis, 2012 NICE psoriasis guidance recommends a potent corticosteroid applied as a lotion, solution or gel once daily for four weeks.

If the lesions don’t clear up or improve satisfactorily it recommends trying a different formulation for a further four weeks (e.g. switching from gel to a shampoo or mousse) with or without topical agents to rid difficult to remove scale. If response to treatment is still unsatisfactory, a combined product containing calcipotriol monohydrate (vitamin D) and betamethasone dipropionate (a steroid) can be used once daily for four weeks or vitamin D alone once daily up to eight weeks.

What are the implications?

The review suggests topical steroids alone or in combination with vitamin D are more effective and safer at treating scalp psoriasis than vitamin D alone.

We should be cautious of taking these findings at face value as some trials were industry sponsored. An additional 14 trials were identified but unavailable for inclusion in the analysis. There is the potential that industry sponsorship favours publishing of positive results rather than negative findings. For this review most comparisons contained fewer than ten studies and the authors say they were not able to statistically test for this bias.

Other types of topical treatments, such as coal tar, were included in the scope of the review but there was insufficient evidence found to draw any conclusions.

Citation and Funding

Schlager JG, Rosumeck S, Werner R. et al. Topical treatments for scalp psoriasis. Cochrane Database Syst Rev. 2016;(2):CD009687.

No funding information was provided for this study.

Bibliography

NICE. Psoriasis: assessment and management. CG153. London: National Institute of Health and Care Excellence; 2012.

PAPAA. Scalp psoriasis. St Albans: The Psoriasis and Psoriatic Arthritis Alliance; 2015.

Why was this study needed?

Psoriasis is a common condition affecting around two in every 100 people in Western Europe and the US. The vast majority of people with psoriasis have it affect their scalp causing red patches of skin covered in thick silvery-white scales.

These scaly lesions are visible and can cause embarrassment. Scalp psoriasis can also be extremely itchy, although some people have no discomfort. In extreme cases it can cause hair loss, although this is usually only temporary.

Topical treatments (creams and ointments for the skin) such as corticosteroids (steroids) and vitamin D are usually the first treatments tried, but applying them to the scalp is difficult because of hair on the head. It is also not clear which works best.

This study aimed to help doctors and patients decide which of the wide variety of topical treatments available work best, and the type and frequency of any side effects.

What did this study do?

This Cochrane systematic review included 59 randomised controlled trials of 11,561 participants up to August 2015. All ages were included.

The main outcomes of interest were ‘clearance’ or ‘response’ of psoriasis as assessed by a doctor or the patient themselves using ratings of whether scalp lesions had improved or cleared up completely. Adverse events requiring stopping of treatment, such as allergic reactions, were also recorded.

Three main comparisons of topical treatments were made: topical steroid alone versus vitamin D alone; combination therapy (corticosteroid and vitamin D therapy) versus steroid alone; combination therapy versus vitamin D alone.

Trials concerning these three outcomes were rated as moderate or high quality, most lasted less than six months, and around half were carried out or sponsored by the manufacturer of the study medication. Sponsor involvement can bias results – in this case they can be more likely to find differences where there are none, or discover differences that are artificially large.

What did it find?

  • Patient-rated treatment response using steroids alone was 48% better than those on vitamin D only (Relative Risk [RR], 1.48% 95%CI 1.28 to 1.72). This meant around five patients would need to be treated with steroids to achieve one extra patient who rates themselves as having “responded” to treatment. Steroids in combination with vitamin D were 13% better than vitamin D alone meaning around 13 people would need to be treated for one extra person to benefit in the same way – a difference not considered to be clinically important.
  • Patients and doctors gave similar ratings of improvements.
  • Participants who applied vitamin D alone stopped treatment more often because of adverse effects than those who applied a topical steroid alone or in combination with vitamin D. (RR 0.70, 95% CI 0.58 to 0.85).

What does current guidance say on this issue?

For initial treatment of scalp psoriasis, 2012 NICE psoriasis guidance recommends a potent corticosteroid applied as a lotion, solution or gel once daily for four weeks.

If the lesions don’t clear up or improve satisfactorily it recommends trying a different formulation for a further four weeks (e.g. switching from gel to a shampoo or mousse) with or without topical agents to rid difficult to remove scale. If response to treatment is still unsatisfactory, a combined product containing calcipotriol monohydrate (vitamin D) and betamethasone dipropionate (a steroid) can be used once daily for four weeks or vitamin D alone once daily up to eight weeks.

What are the implications?

The review suggests topical steroids alone or in combination with vitamin D are more effective and safer at treating scalp psoriasis than vitamin D alone.

We should be cautious of taking these findings at face value as some trials were industry sponsored. An additional 14 trials were identified but unavailable for inclusion in the analysis. There is the potential that industry sponsorship favours publishing of positive results rather than negative findings. For this review most comparisons contained fewer than ten studies and the authors say they were not able to statistically test for this bias.

Other types of topical treatments, such as coal tar, were included in the scope of the review but there was insufficient evidence found to draw any conclusions.

Citation and Funding

Schlager JG, Rosumeck S, Werner R. et al. Topical treatments for scalp psoriasis. Cochrane Database Syst Rev. 2016;(2):CD009687.

No funding information was provided for this study.

Bibliography

NICE. Psoriasis: assessment and management. CG153. London: National Institute of Health and Care Excellence; 2012.

PAPAA. Scalp psoriasis. St Albans: The Psoriasis and Psoriatic Arthritis Alliance; 2015.

Topical treatments for scalp psoriasis

Published on 27 February 2016

Schlager, J. G.,Rosumeck, S.,Werner, R. N.,Jacobs, A.,Schmitt, J.,Schlager, C.,Nast, A.

Cochrane Database Syst Rev Volume 2 , 2016

BACKGROUND: People with chronic plaque psoriasis often have lesions on the scalp. Hair makes the scalp difficult to treat and the adjacent facial skin is particularly sensitive to topical treatments. OBJECTIVES: To assess the efficacy and safety of topical treatments for scalp psoriasis. SEARCH METHODS: We searched the following databases up to August 2015: the Cochrane Skin Group Specialised Register, CENTRAL (2015, Issue 7), MEDLINE (from 1946), EMBASE (from 1974) and LILACS (from 1982). We also searched five trials registers, screened abstracts of six psoriasis-specific conferences and checked the reference lists of included studies for further references to relevant randomised controlled trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) with a parallel-group, cross-over or within-patient design of topical treatments for people of all ages with scalp psoriasis. DATA COLLECTION AND ANALYSIS: Two authors independently carried out study selection, data extraction and 'Risk of bias' assessment. Disagreements were settled by reference to a third author.To assess the quality of evidence, we focused on the following outcomes: 'clearance' or 'response' as assessed by the investigator global assessment (IGA), improvement in quality of life, adverse events requiring withdrawal of treatment and 'response' as assessed by the patient global assessment (PGA).We expressed the results of the single studies as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes, and mean differences (MD) with 95% CI for continuous outcomes. If studies were sufficiently homogeneous, we meta-analysed the data by using the random-effects model. Where it was not possible to calculate a point estimate for a single study, we described the data qualitatively. We also presented the number needed to treat to benefit (NNTB).We categorised topical corticosteroids according to the German classification of corticosteroid potency as mild, moderate, high and very high. MAIN RESULTS: We included 59 RCTs with a total of 11,561 participants. Thirty studies were either conducted or sponsored by the manufacturer of the study medication. The risk of bias varied considerably among the included studies. For instance, most authors did not state the randomisation method and few addressed allocation concealment. Most findings were limited to short-term treatments, since most studies were conducted for less than six months. Only one trial investigated long-term therapy (12 months). Although we found a wide variety of different interventions, we limited the grading of the quality of evidence to three major comparisons: steroid versus vitamin D, two-compound combination of steroid and vitamin D versus steroid monotherapy and versus vitamin D.In terms of clearance, as assessed by the IGA, steroids were better than vitamin D (RR 1.82; 95% CI 1.52 to 2.18; four studies, 2180 participants, NNTB = 8; 95% CI 7 to 11; moderate quality evidence). Statistically, the two-compound combination was superior to steroid monotherapy, however the additional benefit was small (RR 1.22; 95% CI 1.08 to 1.36; four studies, 2474 participants, NNTB = 17; 95% CI 11 to 41; moderate quality evidence). The two-compound combination was more effective than vitamin D alone (RR 2.28; 95% CI 1.87 to 2.78; four studies, 2008 participants, NNTB = 6; 95% CI 5 to 7; high quality evidence).In terms of treatment response, as assessed by the IGA, corticosteroids were more effective than vitamin D (RR 2.09; 95% CI 1.80 to 2.41; three studies, 1827 participants; NNTB = 4; 95% CI 4 to 5; high quality evidence). The two-compound combination was better than steroid monotherapy, but the additional benefit was small (RR 1.15; 95% CI 1.06 to 1.25; three studies, 2444 participants, NNTB = 13; 95% CI 9 to 24; moderate quality evidence). It was also more effective than vitamin D alone (RR 2.31; 95% CI 1.75 to 3.04; four studies, 2222 participants, NNTB = 3; 95% CI 3 to 4; moderate quality evidence).Reporting of quality of life data was poor and data were insufficient to be included for meta-analysis.Steroids caused fewer withdrawals due to adverse events than vitamin D (RR 0.22; 95% CI 0.11 to 0.42; four studies, 2291 participants; moderate quality evidence). The two-compound combination and steroid monotherapy did not differ in the number of adverse events leading withdrawal (RR 0.88; 95% CI 0.42 to 1.88; three studies, 2433 participants; moderate quality evidence). The two-compound combination led to fewer withdrawals due to adverse events than vitamin D (RR 0.19; 95% CI 0.11 to 0.36; three studies, 1970 participants; high quality evidence). No study reported the type of adverse event requiring withdrawal.In terms of treatment response, as assessed by the PGA, steroids were more effective than vitamin D (RR 1.48; 95% CI 1.28 to 1.72; three studies, 1827 participants; NNTB = 5; 95% CI 5 to 7; moderate quality evidence). Statistically, the two-compound combination was better than steroid monotherapy, however the benefit was not clinically important (RR 1.13; 95% CI 1.06 to 1.20; two studies, 2226 participants; NNTB = 13; 95% CI 9 to 26; high quality evidence). The two-compound combination was more effective than vitamin D (RR 1.76; 95% CI 1.46 to 2.12; four studies, 2222 participants; NNTB = 4; 95% CI 3 to 6; moderate quality evidence).Common adverse events with these three interventions were local irritation, skin pain and folliculitis. Systemic adverse events were rare and probably not drug-related.In addition to the results of the major three comparisons we found that the two-compound combination, steroids and vitamin D monotherapy were more effective than the vehicle. Steroids of moderate, high and very high potency tended to be similarly effective and well tolerated. There are inherent limitations in this review concerning the evaluation of salicylic acid, tar, dithranol or other topical treatments. AUTHORS' CONCLUSIONS: The two-compound combination as well as corticosteroid monotherapy were more effective and safer than vitamin D monotherapy. Given the similar safety profile and only slim benefit of the two-compound combination over the steroid alone, monotherapy with generic topical steroids may be fully acceptable for short-term therapy.Future RCTs should investigate how specific therapies improve the participants' quality of life. Long-term assessments are needed (i.e. 6 to 12 months).

‘Clearance’ and ‘response’ of scalp psoriasis was determined by the Investigators Global Assessment of Disease Severity (IGA) scale and the Patients Global Assessment of Disease Severity (PGA) scale. The scales range from 0 to 5 or 6 (depending on the type of scale used) where 0 refers to ‘completely clear’ and higher numbers referring to less improvement, no improvement or a worsening of severity.

Expert commentary

Involvement of the scalp is one of the most common and distressing manifestations of psoriasis. This review shows that monotherapy with corticosteroids of at least potent strength is significantly more effective and better tolerated than vitamin D preparations and that any additional benefit of the more expensive, widely prescribed two-compound formulation is marginal. These findings are in-line with NICE guidelines on treatment of scalp psoriasis, where potent corticosteroids are recommended first line. As highlighted by the authors, the safety data on corticosteroids are reassuring, but relate only to short term use. Longer term studies reflecting real world use of potent/very potent steroids are required.

Professor Catherine Smith, Consultant Dermatologist, Guys and St Thomas’ Foundation Trust