Advertisement

American Journal of Clinical Dermatology

, Volume 16, Issue 5, pp 431–437 | Cite as

Efficacy of Oral Itraconazole in the Treatment and Relapse Prevention of Moderate to Severe Seborrheic Dermatitis: A Randomized, Placebo-Controlled Trial

  • Seyedeh Zahra Ghodsi
  • Zaheer AbbasEmail author
  • Robabeh Abedeni
Original Research Article

Abstract

Background

Seborrheic dermatitis (SD) is a chronic and relapsing disease and topical therapy may be associated with failure, particularly in severe disease. Itraconazole has been suggested as an effective treatment for severe SD. Previous studies have been open clinical trials with variable results.

Objective

The aim of this study was to determine the efficacy of oral itraconazole in the treatment of patients with moderate to severe SD.

Methods

Sixty-eight patients with moderate to severe SD were randomly assigned to the itraconazole (n = 35) or placebo (n = 33) groups. The trial was undertaken in Razi Hospital, Tehran. An internet-generated table was used to allocate treatments. Patients and investigator were blinded to treatments. Itraconazole 200 mg/daily or placebo was prescribed for 1 week and then for the first 2 days of every month for the following 3 months. Patients were followed for 4 months and the Seborrheic Dermatitis Area Severity Index (SDASI) was measured on nine anatomical sites. Fifty-seven patients (29 in the itraconazole group and 28 in the placebo group) completed the study.

Results

Statistically significant improvement was observed in SDASI of both itraconazole and placebo groups (p = 0.000) but the itraconazole group showed significantly higher efficacy compared with placebo (p = 0.023). We observed clinical improvements of 93.8, 87.5, and 93.1 % at the end of 2 weeks, 1 month, and 4 months, respectively, in the itraconazole group, and 82.1, 64.3, and 53.6 % in the placebo group. Furthermore, recurrence rate in the itraconazole group was significantly lower than in the placebo group (p = 0.003). No blood test abnormality was seen in any patient.

Conclusion

Itraconazole is not only an effective and safe therapy for controlling exacerbations of SD but may also be used as maintenance therapy to prevent disease recurrence.

Keywords

Itraconazole Terbinafine Topical Therapy Subjective Global Assessment Seborrheic Dermatitis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Compliance with ethical standards

All candidates for participation in this study were informed clearly and understandably about the possible risks or benefits of the trial and informed written consent was provided by each patient. The approval of the study was obtained by the local and university ethics committee and performed in accordance with the Declaration of Helsinki. This study was funded by Tehran University of Medical Sciences. I, Zaheer Abbas, the corresponding author, and Seyedeh Zahra Ghodsi and Robabeh Abedeni, the co-authors of this manuscript, declare no conflict of interest that is relevant to the content of this study.

References

  1. 1.
    Faergemann J. Pityrosporum infections. J Am Acad Dermatol. 1994;31(3 Pt 2):S18–20.CrossRefPubMedGoogle Scholar
  2. 2.
    Papp KA, Papp A, Dahmer B, Clark CS. Single blind randomized controlled trial evaluating the treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment compared with tacrolimus 0.1% ointment in adults. J Am Acad Dermatol. 2012;67(1):e11–5.CrossRefPubMedGoogle Scholar
  3. 3.
    Dessinioti C, Katsambas A. Seborrehic dermatitis: etiology, risk factors, and treatments: facts and controversies. Clin Dermatol. 2013;31(4):343–51.CrossRefPubMedGoogle Scholar
  4. 4.
    Ostlere LS, Taylor CR, Harris DW, Rustin MH, Wright S, Johnson M. Skin surface lipids in HIV-positive patients with and without seborrheic dermatitis. Int J Dermatol. 1996;35(4):276–9.CrossRefPubMedGoogle Scholar
  5. 5.
    Gupta AK, Richardson M, Paquet M. Systemic review of oral treatments for seborrheic dermatitis. J Eur Acad Dermatol Venereol. 2014;28(1):16–26.CrossRefPubMedGoogle Scholar
  6. 6.
    Baysal V, Yildirim M, Ozcanli C, Ceyhan AM. Itraconazole in the treatment of seborrheic dermatitis: a new treatment modality. Int J Dermatol. 2004;43(1):63–6.CrossRefPubMedGoogle Scholar
  7. 7.
    Shemer A, Kaplan B, Nathansohn N, Grunwald MH, Amichai B, Trau H. Treatment of moderate to severe facial seborrheic dermatitis with itraconazole: an open non-comparative study. Isr Med Assoc J. 2008;10(6):417–8.PubMedGoogle Scholar
  8. 8.
    Cömert A, Bekiroglu N, Gürbüz O, Ergun T. Efficacy of oral fluconazole in the treatment of seborrheic dermatitis: a placebo-controlled study. Am J Clin Dermatol. 2007;8(4):235–8.CrossRefPubMedGoogle Scholar
  9. 9.
    Conti-Diaz IA, Civila E, Asconegui F. Treatment of superficial and deep seated mycoses with oral ketoconazole. Int J Dermatol. 1984;23:207–10.CrossRefPubMedGoogle Scholar
  10. 10.
    Ford GP, Farr PM, Ive FA, Shuster S. The response of seborrhoeic dermatitis to ketoconazole. Br J Dermatol. 1984;111:603–7.CrossRefPubMedGoogle Scholar
  11. 11.
    Cassano N, Amoruso A, Loconsole F, Vena GA. Oral terbinafine for the treatment of seborrheic dermatitis in adults. Int J Dermatol. 2002;41:821–2.CrossRefPubMedGoogle Scholar
  12. 12.
    Scaparro E, Quadri G, Virno G, et al. Evaluation of the efficacy and tolerability of oral terbinafine (Daskil_) in patients with seborrhoeic dermatitis. A multicentre, randomized, investigator-blinded, placebo-controlled trial. Br J Dermatol. 2001;144:854–7.CrossRefPubMedGoogle Scholar
  13. 13.
    Vena GA, Micali G, Santoianni P, et al. Oral terbinafine in the treatment of multi-site seborrhoic dermatitis: a multicenter, double-blind placebo-controlled study. Int J Immunopathol Pharmacol. 2005;18:745–53.PubMedGoogle Scholar
  14. 14.
    Pierard GE, Ausma J, Henry F, et al. A pilot study on seborrheic dermatitis using pramiconazole as a potent oral anti-Malassezia agent. Dermatology. 2007;214:162–9.PubMedGoogle Scholar
  15. 15.
    Kose O, Erbil H, Gur AR. Oral itraconazole for the treatment of seborrhoeic dermatitis: an open, noncomparative trial. J Eur Acad Dermatol Venereol. 2005;19(2):172–5.CrossRefPubMedGoogle Scholar
  16. 16.
    Das J, Majumdar M, Chakraborty YU, et al. Oral itraconazole for the treatment of severe seborrhoeic dermatitis. Indian J Dermatol. 2011;56:515–6.PubMedCentralCrossRefPubMedGoogle Scholar
  17. 17.
    Caputo R, Barbareschi M. Itraconazole: new horizons. G Ital Dermatol Venereol. 2002;137:1–7.Google Scholar
  18. 18.
    Khondker L, Choudhury AM, Wahab MA, Khan MSI. Efficacy of oral itraconazole in the treatment of seborrheic dermatitis. J Bangladesh Coll Phys Surg. 2012;29:201–6.Google Scholar
  19. 19.
    Rosen T, Schell BJ, Orengo I. Anti inflammatory activity of antifungal preparations. Int J Dermatol. 1997;36(10):788–92.CrossRefPubMedGoogle Scholar
  20. 20.
    Elewski BE. Mechanisms of action of systemic antifungal agents. J Am Acad Dermatol. 1993;28(5 Pt 1):S28–34.CrossRefPubMedGoogle Scholar
  21. 21.
    Sehgal VN, Khandpur S. Antifungal agents: unapproved uses, dosages, or indications. Clin Dermatol. 2002;20(5):481–9.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Department of DermatologyRazi Hospital, Tehran University of Medical SciencesTehranIran

Personalised recommendations