An Open-Label Pilot Study of Naftifine 1% Gel in the Treatment of Seborrheic Dermatitis of the Scalp
April 2012 | Volume 11 | Issue 4 | 514 | Copyright © April 2012
Michael H. Gold MD,a Tancy Bridges RN NPC,a Edward V. Avakian MA PhD,b Stefan Plaum MD, b Alan B. Fleischer, Jr MD,b Bhushan Hardas MD MBAb
a Gold Skin Care Center and Tennessee Clinical Research Center, Nashville, TN b Merz Pharmaceuticals, LLC, Greensboro, NC
Abstract
Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although the amidazole and ciclopyridine antifungals have been extensively studied, few clinical efficacy data are available for topical allylamine therapy in SD. The objective of
this open-label exploratory study was to evaluate the efficacy and safety of natifine HCl 1% gel applied twice daily for 4 weeks, as
topical treatment of moderate SD of the scalp. Nine subjects (5 men, 4 women) with a mean age of 56 (33-81) years with SD of
the scalp were enrolled and made 4 visits to the site. At Visit 1 (Week 0), subjects were screened, enrolled, baseline efficacy data
were obtained, and treatment was initiated. Subjects returned at Week 2, Week 4 (end of treatment), and Week 6 for efficacy and
safety assessments. Efficacy was evaluated by changes from baseline in investigator-rated scores on 0-5-grade scales: (1) SD Global
Evaluation Scale (SDGES), (2) Erythema Severity Scale, (3) Scaling Severity Scale, (4) % Scalp Involvement Scale, and subject-rated
scores on the (4) Itching Severity Scale, and (5) Global Improvement Scale, where 0=none and 5=most severe. Mean severity
scores for the SDGES and % Scalp Involvement scales progressively declined (improved) 66% and 54% from respective baseline
levels at Week 6. Mean erythema rating decreased 38% from baseline and scaling decreased 50% from baseline by Weeks 4 and 6.
Itching improved in 5 of 9 (56%) subjects by the end of treatment. A total of 8 of 9 (89%) subjects rated their symptoms as improved
from baseline at the end of treatment and Week 6. There were no treatment-related adverse events during the study. These results
suggest that naftifine 1% gel applied twice daily for 4 weeks is effective and safe topical treatment for moderate SD of the scalp.
J Drugs Dermatol.2012;11(4):514-518.
INTRODUCTION
Seborrheic dermatitis (SD) is a common, recurrent, cutaneous inflammatory disorder of unknown etiology, characterized by loose, poorly defined, erythematous, scaly patches,
and often pruritus.1 It is most often found on the scalp, face, and
other areas with high concentrations of sebaceous glands. 2 There
are both infantile and adult forms of SD: Infantile (cradle cap) occurs in approximately 65% of infants during the first 12 months of
life with the peak incidence at 3 months.3,4 The adult form of SD affects approximately 5-10% of the general population with the highest incidence occurring during the 4th and 5th decades.3Seborrehic
dermatitis is typically recurrent and affects men more than women.3 Dandruff is believed to be a milder form of SD confined to the
scalp, characterized by smaller, drier scales, with decreased lipid
content, and impaired barrier function of the stratum corneum. 4,5
Although the pathogenesis of SD is incompletely understood,
there is increasing evidence that inflammatory changes in the
cornified epithelium induced by colonization of the commensal
lipophilic Malassezia yeasts, play a primary etiological role in
SD.1,2,5,6 Individuals with SD have significantly elevated colony
counts of Malassezia globosa and M restricta, which decrease in
response to topical or systemic antifungal therapy, as do clinical
signs and symptoms. 1,5,6,7Immunocompromised individuals, such
as those with acquired immunodeficiency syndrome (HIV) and
CD4 T cell counts lower than 400 cells/mm,3 have a much higher
incidence of SD.2,8 For unknown reasons, the frequency of SD is
also higher in patients with certain neurological disorders such as
Parkinson's disease or stroke and in those taking lithium or antipsychotic agents such as haloperidol and chlorpromazine.2,7
