Topical anti‐inflammatory agents for seborrhoeic dermatitis of the face or scalp

Abstract

Background

Seborrhoeic dermatitis is a chronic inflammatory skin disorder affecting primarily the skin of the scalp, face, chest, and intertriginous areas, causing scaling and redness of the skin. Current treatment options include antifungal, anti‐inflammatory, and keratolytic agents, as well as phototherapy.

Objectives

To assess the effects of topical pharmacological interventions with established anti‐inflammatory action for seborrhoeic dermatitis occurring in adolescents and adults.

Search methods

We searched the following databases up to September 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 9), MEDLINE (from 1946), Embase (from 1974), LILACS (from 1982), and the GREAT database. We searched five trials databases and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).

Selection criteria

We included RCTs in adults or adolescents (> 16 years) with diagnosed seborrhoeic dermatitis of the scalp or face, comparing topical anti‐inflammatory treatments (steroids, calcineurin inhibitors, and lithium salts) with other treatments.

Data collection and analysis

Pairs of authors independently assessed eligibility for inclusion, extracted data, and evaluated the risk of bias. We performed meta‐analyses if feasible.

Main results

We included 36 RCTs (2706 participants), of which 31 examined topical steroids; seven, calcineurin inhibitors; and three, lithium salts. The comparative interventions included placebo, azoles, calcipotriol, a non‐steroidal anti‐inflammatory compound, and zinc, as well as different anti‐inflammatory treatments compared against each other. Our outcomes of interest were total clearance of symptoms, erythema, scaling or pruritus scores, and adverse effects. The risk of bias in studies was most frequently classified as unclear, due to unclear reporting of methods.

Steroid treatment resulted in total clearance more often than placebo in short‐term trials (four weeks or less) (relative risk (RR) 3.76, 95% confidence interval (CI) 1.22 to 11.56, three RCTs, 313 participants) and in one long‐term trial (lasting 12 weeks). Steroids were also more effective in reducing erythema, scaling, and pruritus. Adverse effects were similar in both groups.

There may be no difference between steroids and calcineurin inhibitors in total clearance in the short‐term (RR 1.08, 95% 0.88 to 1.32, two RCTs, 60 participants, low‐quality evidence). Steroids and calcineurin inhibitors were found comparable in all other assessed efficacy outcomes as well (five RCTs, 237 participants). Adverse events were less common in the steroid group compared with the calcineurin group in the short‐term (RR 0.22, 95% CI 0.05 to 0.89, two RCTs, 60 participants).

There were comparable rates of total clearance in the steroid and azole groups (RR 1.11, 95% CI 0.94 to 1.32, eight RCTs, 464 participants, moderate‐quality evidence) as well as of adverse effects in the short‐term, but less erythema or scaling with steroids.

We found mild (class I and II) and strong (class III and IV) steroids comparable in the assessed outcomes, including adverse events. The only exception was total clearance in long‐term use, which occurred more often with a mild steroid (RR 0.79, 95% CI 0.63 to 0.98, one RCT, 117 participants, low‐quality evidence).

In one study, calcineurin inhibitor was more effective than placebo in reducing erythema and scaling, but there were similar rates in total clearance or adverse events for short‐term treatment. In another study, calcineurin inhibitor was comparable with azole when erythema, scaling, or adverse effects were measured for longer‐term treatment.

Lithium was more effective than placebo with regard to total clearance (RR 8.59, 95% CI 2.08 to 35.52, one RCT, 129 participants) with a comparable safety profile. Compared with azole, lithium resulted in total clearance more often (RR 1.79, 95% CI 1.10 to 2.90 in short‐term treatment, one RCT, 288 participants, low‐quality evidence).

Authors' conclusions

Topical steroids are an effective treatment for seborrhoeic dermatitis of the face and scalp in adolescents and adults, with no differences between mild and strong steroids in the short‐term. There is some evidence of the benefit of topical calcineurin inhibitor or lithium salt treatment. Treatment with azoles seems as effective as steroids concerning short‐term total clearance, but in other outcomes, strong steroids were more effective. Calcineurin inhibitor and azole treatment appeared comparable. Lithium salts were more effective than azoles in producing total clearance.

Steroids are similarly effective to calcineurin inhibitors but with less adverse effects.

Most of the included studies were small and short, lasting four weeks or less. Future trials should be appropriately blinded; include more than 200 to 300 participants; and compare steroids to calcineurin inhibitors or lithium salts, and calcineurin inhibitors to azoles or lithium salts. The follow‐up time should be at least one year, and quality of life should be addressed. There is also a need for the development of well‐validated outcome measures.

Author(s)

Helena Kastarinen, Tuija Oksanen, Enembe O Okokon, Vesa V Kiviniemi, Kristiina Airola, Johanna Jyrkkä, Tuomas Oravilahti, Piia K Rannanheimo, Jos H Verbeek

Abstract

Plain language summary

Topical anti‐inflammatory agents for seborrhoeic dermatitis of the face or scalp

Seborrhoeic dermatitis is an inflammation of the skin that most often affects areas of the body that have a lot of sebaceous glands. These include the skin of the scalp; face; chest; and flexure areas such as the armpits, groin, and abdominal folds. The most typical symptoms of seborrhoeic dermatitis are scaling of the skin and reddish patches. Seborrhoeic dermatitis is fairly common: one to three in 100 people have seborrhoeic dermatitis. The disease is more common in men than in women. Anti‐inflammatory, antifungal, and antikeratolytic treatments can be used to treat seborrhoeic dermatitis. The treatment does not cure the disease but relieves the symptoms.

We included 36 randomised controlled trials with 2706 participants, examining the effect of anti‐inflammatory treatments on seborrhoeic dermatitis. These trials were short‐term; most of them lasting four weeks or less.

Topical steroid treatment (such as hydrocortisone and betamethasone), topical calcineurin inhibitor treatment (such as tacrolimus and pimecrolimus), and topical lithium salts all reduced the symptoms of seborrhoeic dermatitis when compared with placebo treatment. Mild (such as hydrocortisone 1%) and strong (such as betamethasone) steroid compounds were comparable in short‐term follow up. Short‐term total clearance was achieved with antifungal azole treatment (such as ketoconazole and miconazole), as well as with steroids. Strong steroids were better than azole treatment in reducing erythema, scaling, and pruritus, and were comparable in terms of safety. Steroids were also as effective as calcineurin inhibitors, but side‐effects occurred more often with calcineurin inhibitors. We found no differences between calcineurin inhibitors and azole treatments in effectiveness or side‐effects. Lithium was more effective than azoles but had a similar frequency of side‐effects (one study).

The most common side‐effects were burning, itching, erythema, and dryness in all treatment groups.

Topical anti‐inflammatory agents are useful in treating seborrhoeic dermatitis. Steroids are the most investigated anti‐inflammatories. We still do not know the effects and safety of topical anti‐inflammatory treatments in long‐term or continuous use. This is regrettable as the disease is chronic in nature. Furthermore, there are no data concerning the effects of different treatments on quality of life.

Author(s)

Helena Kastarinen, Tuija Oksanen, Enembe O Okokon, Vesa V Kiviniemi, Kristiina Airola, Johanna Jyrkkä, Tuomas Oravilahti, Piia K Rannanheimo, Jos H Verbeek

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Topical steroids and lithium salts are more effective than placebo in achieving total clearance in seborrhoeic dermatitis of the face or scalp. Calcineurin inhibitors show benefit over placebo in reducing erythema and scaling. Azoles may be comparable to steroids in achieving total clearance, but there are implications that strong steroids are more efficient with symptoms like erythema, scaling, and pruritus. Furthermore, adverse effects occur at a similar rate at four weeks' follow‐up. Calcineurin inhibitors seem to be comparable with azoles and steroids concerning efficacy. Lithium is more effective than azole with regard to total clearance. Mild and strong steroids seemed to be comparable with regard to efficacy and adverse effects in up to six weeks' follow‐up. However, there are no data regarding the efficacy or safety of repeated, long‐term (such as more than one year), or continuous use of any of the assessed medicines.

The median rate of achieving total clearance was 53% with anti‐inflammatory treatments across studies. This is an indication of the need for further research to identify optimal treatment agents, possibly treatment combinations, regimens, and length.

Implications for research 

To prevent reporting bias, authors should first publish a protocol of their study and register this in a trials registration database. To further increase the quality of evidence of topical anti‐inflammatory treatments for seborrhoeic dermatitis, future trials should deal with the following issues.

  • Quality of methods: Trials should properly conduct and report random sequence allocation, as well as allocation concealment and the method of blinding.
  • Quality of reporting: Trials should report results in numbers, preferably in tables, instead of graphs, as well as reporting standard deviations and exact P values.
  • Outcomes: There is an urgent need for one or more validated outcome measures for seborrhoeic dermatitis that should at least cover erythema, scaling, pruritis, and the area of the body and the amount of skin affected. Trials should also examine patient‐centered outcomes, such as quality‐adjusted life measures, as well as compliance. Trials should measure outcomes at long‐term follow up, such as one year after starting treatment, in order to assess the relapse rate or the efficacy in long‐term use. For adverse effects, we need measurements at several years of follow up.
  • Economic evaluations: Trials should put the therapeutic value of a treatment into context with its economic value in order to be able to use treatments rationally.

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