Clinical Review & Education

JAMA Dermatology Clinical Evidence Synopsis

Topical Anti-inflammatory Agents for Seborrheic Dermatitis of the Face or Scalp Summary of a Cochrane Review Helena Kastarinen, MD, PhD; Enembe O. Okokon, MD, MSc; Jos H. Verbeek, MD, PhD

CLINICAL QUESTION Are there differences in effectiveness between topical anti-inflammatory treatments (steroids, calcineurin inhibitors, or lithium salts) and placebo or azoles in the treatment of seborrheic dermatitis of the face and scalp in adults? BOTTOM LINE The topical anti-inflammatory treatments were more effective in achieving total clearance of symptoms than placebo by 1.4-fold to 8.5-fold, but there are no considerable differences in the anti-inflammatory topical treatments or in comparison with azoles for short-term treatment. There is no evidence of treatment effects in long-term, continuous, or intermittent use of these compounds despite the chronic nature of the disease.

Seborrheic dermatitis is a common (prevalence of 1%-3% among adults) chronic inflammatory skin disorder affecting primarily the skin of the scalp, face, chest, and intertriginous areas, causing scaling and redness of the skin.1 Current treatment options include antifungal, anti-inflammatory, and keratolytic agents, as well as phototherapy. There are many available treatment options, but it is unclear which should be preferred. This review summarizes the comparative efficacy and adverse effects of topical anti-inflammatory treatments (including steroids, calcineurin inhibitors, and lithium salts) in seborrheic dermatitis affecting the face and scalp.2

Evidence Profile No. of trials: 36 No. of randomized clinical trials: 36 Study years: 1970 to 2012 No. of patients: 2706 Male: 62% Female: 38% (from 31 trials [2526 participants]) Age: 13 to 88 years (data available in 30 trials) Setting: Outpatient Countries: Worldwide 17 countries

Summary of Findings Thirty-one randomized clinical trials examined topical steroids, 7 examined calcineurin inhibitors, and 3, lithium salts. Overall, the median (range) rate of achieving total clearance was 53% (13%-100%) with anti-inflammatory treatments (topical steroids, calcineuEditorial page 127 rin inhibitors, or lithium salts) across studies, and the median (range) rate of adverse effects was 7% (0%-57%). The most commonly reported adverse effects were burning, itching, erythema, and dandruff. In the short term (ⱕ4 weeks), there were no statistically significant differences between steroid therapy and calcineurin inhibitor therapy in total clearance (relative risk [RR], 1.08 [95% CI, 0.88-1.32]) (Table). Steroids and calcineurin inhibitors were comparable in all other outcomes as well. Adverse events were less common in the steroid group compared with the calcineurin inhibitors group in the short term (RR, 0.22 [95% CI, 0.05-0.89]). Also in the short term, the rates of total clearance were comparable between the topical steroid and azole groups (RR, 1.11 [95% CI, 0.94-1.32]) (Table), but there was less erythema and scaling associated with steroid use. In general, mild and strong steroids had comparable therapeutic effects and adverse events. The only exception was total clearance with long-term (>4 weeks) use, which occurred more often with jamadermatology.com

Comparisons: • Steroids vs placebo • Steroids vs calcineurin inhibitors • Steroids vs azoles • Mild steroids (class I-II) vs strong steroids (class III-IV) • Calcineurin inhibitors vs placebo • Calcineurin inhibitors vs azoles • Calcineurin inhibitors vs pyrithione zinc • Lithium salts vs placebo • Lithium salts vs azoles Primary outcomes: • Total clearance • Disease severity scores for scaling, pruritus, and erythema • Adverse effects Secondary outcome: Quality of life

a mild than with a strong steroid (RR, 1.27 [95% CI, 1.02-1.58]). Treatment with lithium salts resulted in total clearance more often than treatment with azoles (RR, 1.79 [95% CI, 1.10-2.90], ⱕ4 weeks) but had similar rates of reported adverse effects.

Discussion Only minor differences in treatment effects among anti-inflammatory treatments were found. Strong steroids were more (Reprinted) JAMA Dermatology February 2015 Volume 151, Number 2

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Clinical Review & Education JAMA Dermatology Clinical Evidence Synopsis

Table. Total Clearance of Symptoms in Less Than 4 Weeks in Studies With Active Comparators (Not Placebo) With Total Clearance as Primary Outcome

Comparison, Intervention vs Control

Total Clearance Rate (Illustrative Comparative Risk), per 1000 Patients Studies, No.

Participants, No.

Intervention

Control

OR (95% CI)

RR (95% CI)

Steroid vs calcineurin inhibitor

2

60

906

839

1.89 (0.38-9.27)

1.08 (0.88-1.32)

Steroid vs azole

8

464

526

474

1.28 (0.87-1.88)

1.11 (0.94-1.32)

Mild vs strong steroid

2

93

413

397

0.88 (0.31-2.54)

0.96 (0.65-1.40)

Lithium vs azole

1

288

263

147

2.07 (1.14-3.76)

1.79 (1.10-2.90)

Abbreviations: OR, odds ratio; RR, relative risk.

effective than azoles in reducing erythema, scaling, and pruritus, but both treatment modalities were comparable regarding safety profiles. The efficacy of steroids was also comparable to that of calcineurin inhibitors, but with fewer adverse effects. Mild and strong steroid compounds were comparable in achieving total clearance at short-term follow-up. No significant differences between calcineurin inhibitor and azole treatments in effectiveness or adverse effects were found. Lithium salts were more effective than azoles but had a similar frequency of adverse effects. On the basis of this review, there are no clear differences in treatment effects among the assessed treatment options. Limitations

The clinical trials were of short duration, and studies on long-term, continuous, or repeated use of anti-inflammatory agents are lacking. The trials did not include many people of African origin, which ARTICLE INFORMATION Author Affiliations: Social Insurance Institute of Finland, Regional Office for Eastern Finland, Kuopio, Finland (Kastarinen); Department of Community Medicine, University of Calabar Teaching Hospital, Calabar, Nigeria (Okokon); Cochrane Occupational Safety and Health Review Group, Finnish Institute of Occupational Health, Kuopio, Finland (Verbeek). Corresponding Author: Helena Kastarinen, MD, PhD, Social Insurance Institute of Finland, Regional Office for Eastern Finland, Kuopio, Finland (helena [email protected]). Published Online: January 28, 2015. doi:10.1001/jamadermatol.2014.3186. Conflict of Interest Disclosures: None reported.

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is important because seborrheic dermatitis may have different presentations in these individuals. Only trials investigating face or scalp involvement were included. Combination treatments with multiple different classes of topical therapies were not included. In general, the level of evidence was low to moderate according to Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Areas in Need of Future Study

Studies with a greater number of participants (ⱖ200-300) and longer follow-up time, such as 1 year, would be preferable. Researchers may wish to assess medication adherence and measure quality of life as a part of the study. Because short-term total clearance was achieved in only one-half of the patients with currently available agents, there is a need to identify more efficacious treatments or methods for designing innovative regimens that combine existing treatments.

Funding/Support: This study was supported in part by the Finnish Medicines Agency (FIMEA), Finland; the Finnish Institute of Occupational Health, Finland; the Cochrane Occupational Safety and Health Review Group, Finland; the Nigerian Branch of the South African Cochrane Centre, Nigeria; the National Institute for Health Research as the largest single funder of the Cochrane Skin Group, United Kingdom.

and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Role of the Sponsor: The Finnish Medicines Agency (FIMEA), Finland; the Finnish Institute of Occupational Health, Finland; the Cochrane Occupational Safety and Health Review Group, Finland; the Nigerian Branch of the South African Cochrane Centre, Nigeria; and the National Institute for Health Research as the largest single funder of the Cochrane Skin Group had no role in the design

1. Schwartz RA, Janusz CA, Janniger CK. Seborrheic dermatitis: an overview. Am Fam Physician. 2006; 74(1):125-130.

Additional Contributions: We are indebted to the Cochrane Review Skin Group for publishing the original Cochrane Review. REFERENCES

2. Kastarinen H, Oksanen T, Okokon EO, et al. Topical anti-inflammatory agents for seborrheic dermatitis of the face or scalp. Cochrane Database Syst Rev. 2014;5:CD009446.

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Topical anti-inflammatory agents for seborrheic dermatitis of the face or scalp: summary of a Cochrane Review.

Are there differences in effectiveness between topical anti-inflammatory treatments (steroids, calcineurin inhibitors, or lithium salts) and placebo o...
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