Journal of the American Academy of Dermatology
Volume 59, Issue 1 , Pages 41-54 , July 2008

Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: Results of two randomized, investigator-blinded, multicenter, international, controlled trials∗

  • Boni E. Elewski, MD

      Affiliations

    • Department of Dermatology, University of Alabama, Birmingham, Alabama
    • Corresponding Author InformationReprint requests: Boni E. Elewski, MD, Department of Dermatology, University of Alabama at Birmingham School of Medicine, EFH 414 1530, 3rd Avenue South, Birmingham, AL 35294-0009.
    • ,
  • Hector W. Cáceres, MD

      Affiliations

    • Instituto de Salud Especializado del Niño, Lima, Peru
    • ,
  • Liberation DeLeon, MD

      Affiliations

    • Center for Clinical Trials, LLC, Paramount, Calif
    • ,
  • Saleh El Shimy, MD

      Affiliations

    • Dermatology Department, Misr University of Science and Technology, Cairo, Egypt
    • ,
  • Judy A. Hunter, MD

      Affiliations

    • Health Care Partners Medical Group, Torrance, Calif
    • ,
  • Nicolay Korotkiy, MD

      Affiliations

    • Department of Dermatology, Russian Medical Children's Hospital, Moscow, Russia
    • ,
  • Ingrid Johnson Rachesky, MD

      Affiliations

    • The Clinical Research Center of Northwest Florida, Panama City, Florida
    • ,
  • Victoria Sanchez-Bal, MD

      Affiliations

    • private practice, Bellflower, Calif
    • ,
  • Gail Todd, MD

      Affiliations

    • Division of Dermatology, University of Cape Town, Cape Town, South Africa
    • ,
  • LindaAnn Wraith, MBA

      Affiliations

    • Novartis Pharmaceuticals Corporation, East Hanover, NJ
    • ,
  • Bin Cai, MD

      Affiliations

    • Novartis Pharmaceuticals Corporation, East Hanover, NJ
    • ,
  • Amir Tavakkol, PhD

      Affiliations

    • Novartis Pharmaceuticals Corporation, East Hanover, NJ
    • ,
  • Rajesh Bakshi, MD

      Affiliations

    • Novartis Pharma AG, Basel, Switzerland
    • ,
  • Judit Nyirady, MD, MBA

      Affiliations

    • Novartis Pharmaceuticals Corporation, East Hanover, NJ
    • ,
  • Sheila Fallon Friedlander, MD

      Affiliations

    • Division of Pediatric Dermatology, Children's Hospital, San Diego, Calif

,Accepted 13 February 2007.

References 

  1. Mohrenschlager M, Seidl HP, Ring J, Abeck D. Pediatric tinea capitis: recognition and management. Am J Clin Dermatol. 2005;6:203–213
  2. Aly R, Hay RJ, Del Palacio A, Galimberti R. Epidemiology of tinea capitis. Med Mycol. 2000;38(Suppl 1):183–188
  3. Elewski BE. Tinea capitis: a current perspective. J Am Acad Dermatol. 2000;42:1–20quiz 21-4
  4. Omar AA. Ringworm of the scalp in primary-school children in Alexandria: infection and carriage. East Mediterr Health J. 2000;6:961–967
  5. Schmeller W, Baumgartner S, Dzikus A. Dermatophytomycoses in children in rural Kenya: the impact of primary health care. Mycoses. 1997;40:55–63
  6. Woldeamanuel Y, Leekassa R, Chryssanthou E, Menghistu Y, Petrini B. Prevalence of tinea capitis in Ethiopian schoolchildren. Mycoses. 2005;48:137–141
  7. Cuetara MS, del Palacio A, Pereiro M, Amor E, Alvarez C, Noriega AR. Prevalence of undetected tinea capitis in a school survey in Spain. Mycoses. 1997;40:131–137
  8. Ali-Shtayeh MS, Arda HM, Abu-Ghdeib SI. Epidemiological study of tinea capitis in schoolchildren in the Nablus area (West Bank). Mycoses. 1998;41:243–248
  9. Fuller LC, Child FC, Higgins EM. Tinea capitis in south-east London: an outbreak of Trichophyton tonsurans infection. Br J Dermatol. 1997;136:139
  10. Higgins EM, Fuller LC, Smith CH. Guidelines for the management of tinea capitis. British Association of Dermatologists. Br J Dermatol. 2000;143:53–58
  11. Friedlander SF, Williams JV, Cunningham BB, Eichenfield LF. The case for not omitting evaluation of culture findings for diagnosing tinea capitis. Arch Pediatr Adolesc Med. 2000;154:637–638
  12. Gupta AK, Summerbell RC. Tinea capitis. Med Mycol. 2000;38:255–287
  13. World Health Organization. Essential Medicines. WHO Model List.:14th edition. March 2005. Available at: http://whqlibdoc.who.int/hq/2005/a87017_eng.pdf. Accessed February 27, 2007.
  14. Roberts BJ, Friedlander SF. Tinea capitis: a treatment update. Pediatr Ann. 2005;34:191–200
  15. Bennett ML, Fleischer AB, Loveless JW, Feldman SR. Oral griseofulvin remains the treatment of choice for tinea capitis in children. Pediatr Dermatol. 2000;17:304–309
  16. Ryder NS. The mechanism of action of terbinafine. Clin Exp Dermatol. 1989;14:98–100
  17. Jessup CJ, Ryder NS, Ghannoum MA. An evaluation of the in vitro activity of terbinafine. Med Mycol. 2000;38:155–159
  18. Butty P, Lebecq JC, Mallie M, Bastide JM. Evaluation of the susceptibility of dermatophytes to antifungal drugs: a new technique. J Med Vet Mycol. 1995;33:403–409
  19. Venugopal PV, Venugopal TV. Disk diffusion susceptibility testing of dermatophytes with allylamines. Int J Dermatol. 1994;33:730–732
  20. Haroon TS, Hussain I, Aman S, Jahangir M, Kazmi AH, Sami AR, et al. A randomized double-blind comparative study of terbinafine for 1, 2 and 4 weeks in tinea capitis. Br J Dermatol. 1996;135:86–88
  21. Friedlander SF, Aly R, Krafchik B, Blumer J, Honig P, Stewart D, et al. Terbinafine in the treatment of Trichophyton tinea capitis: a randomized, double-blind, parallel-group, duration-finding study. Pediatrics. 2002;109:602–607
  22. Jahangir M, Hussain I, Ul Hasan M, Haroon TS. A double-blind, randomized, comparative trial of itraconazole versus terbinafine for 2 weeks in tinea capitis. Br J Dermatol. 1998;139:672–674
  23. Gupta AK, Adam P. Terbinafine pulse therapy is effective in tinea capitis. Pediatr Dermatol. 1998;15:56–58
  24. Gupta AK, Adam P, Dlova N, Lynde CW, Hofstader S, Morar N, et al. Therapeutic options for the treatment of tinea capitis caused by Trichophyton species: griseofulvin versus the new oral antifungal agents, terbinafine, itraconazole, and fluconazole. Pediatr Dermatol. 2001;18:433–438
  25. Fuller LC, Smith CH, Cerio R, Marsden RA, Midgley G, Beard AL, et al. A randomized comparison of 4 weeks of terbinafine vs. 8 weeks of griseofulvin for the treatment of tinea capitis. Br J Dermatol. 2001;144:321–327
  26. Lipozencic J, Skerlev M, Orofino-Costa R, Zaitz VC, Horvath A, Chouela E, et al. Tinea Capitis Study Group A randomized, double-blind, parallel-group, duration-finding study of oral terbinafine and open-label, high-dose griseofulvin in children with tinea capitis due to Microsporum species. Br J Dermatol. 2002;146:816–823
  27. Silm H, Karelson M. Terbinafine: efficacy and tolerability in young children with tinea capitis due to Microsporum canis. J Eur Acad Dermatol Venereol. 2002;16:228–230
  28. Rademaker M, Havill S. Griseofulvin and terbinafine in the treatment of tinea capitis in children. N Z Med J. 1998;111:55–57
  29. Caceres-Rios H, Rueda M, Ballona R, Bustamante B. Comparison of terbinafine and griseofulvin in the treatment of tinea capitis. J Am Acad Dermatol. 2000;42:80–84
  30. Memişoğlu HR, Erboz S, Akkaya S, Akan T, Ünal I, Karakaş M. Comparative study of the efficacy and tolerability of 4 weeks terbinafine therapy with 8 weeks griseofulvin therapy in children with tinea capitis. J Dermatol Treat. 1999;10:189–193
  31. Gupta AK, Adamiak A, Cooper EA. The efficacy and safety of terbinafine in children. J Eur Acad Dermatol Venereol. 2003;17:627–640
  32. Devliotou-Panagiotidou D, Koussidou-Eremondi TH. Efficacy and tolerability of 8 weeks' treatment with terbinafine in children with tinea capitis caused by Microsporum canis: a comparison of three doses. J Eur Acad Dermatol Venereol. 2004;18:155–159
  33. Grifulvin V. [package insert]. Raritan (NJ): Ortho Pharmaceutical Corporation; 1997;
  34. Fleece D, Gaughan JP, Aronoff SC. Griseofulvin versus terbinafine in the treatment of tinea capitis: a meta-analysis of randomized, clinical trials. Pediatrics. 2004;114:1312–1315
  35. Gan VN, Petruska M, Ginsburg CM. Epidemiology and treatment of tinea capitis: ketoconazole vs. griseofulvin. Pediatr Infect Dis J. 1987;6:46–49
  36. Lopez-Gomez S, Del Palacio A, Van Cutsem J, Soledad Cuetara M, Iglesias L, Rodriguez-Noriega A. Itraconazole versus griseofulvin in the treatment of tinea capitis: a double-blind randomized study in children. Int J Dermatol. 1994;33:743–747
  37. Haroon TS, Hussain I, Aman S, Nagi AH, Ahmad I, Zahid M, et al. A randomized double-blind comparative study of terbinafine and griseofulvin in tinea capitis. J Dermatolog Treat. 1995;6:167–169
  38. Foster KW, Friedlander SF, Panzer H, Ghannoum MA, Elewski BE. A randomized controlled trial assessing the efficacy of fluconazole in the treatment of pediatric tinea capitis. J Am Acad Dermatol. 2005;53:798–809
  39. Friedlander SF. The optimal therapy for tinea capitis. Pediatr Dermatol. 2000;17:325–326
  40. Filho ST, Cuce LC, Foss NT, Marques SA, Santamaria JR. Efficacy, safety and tolerability of terbinafine for tinea capitis in children: Brazilian multicentric study with daily oral tablets for 1, 2 and 4 weeks. J Eur Acad Dermatol Venereol. 1998;11:141–146

 Supported by Novartis Pharmaceuticals Corporation.

 Disclosures: Drs Elewski, Cáceres, DeLeon, El Shimy, Hunter, Korotkiy, Rachesky, Sanchez-Bal, Todd, and Friedlander were study investigators and received grants or other financial support from Novartis Pharmaceuticals Corporation. Drs Cai, Tavakkol, and Nyirady and Ms Wraith are employees of Novartis Pharmaceuticals Corporation, East Hanover, NJ. Dr Bakshi is an employee of Novartis Pharma AG, Basel, Switzerland. They receive salary, stock (A.T., J.N.), stock option (A.T., J.N.), and other financial benefits from the company.

 Portions of the data were presented at the Annual Congress of the European Academy of Dermatology and Venereology in Vienna, Austria, May 16-20, 2007.

 ∗A list of all study investigators and other contributors to the study may be found at the end of the article.

PII: S0190-9622(08)00252-1

doi: 10.1016/j.jaad.2008.02.019

Journal of the American Academy of Dermatology
Volume 59, Issue 1 , Pages 41-54 , July 2008

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