Article on New Antifungal Treatment for Seb Derm
Ciclopiroxolamine Cream 1% in the Treatment of Seborrhoeic
Dermatitis: A Double-Blind, Parallel-Group Comparison With
Ketoconazole and Vehicle in a Confirmatory Trial
from Clinical Drug Investigation [TM]
Posted 05/15/2002
A. Unholzer, S. Schinzel, K.-H. Nietsch, G.E. Jung, Hans Christian
Korting
Abstract and Introduction
Abstract
Objective: To compare the efficacy and tolerability of topically
applied ciclopiroxolamine cream with that of ketoconazole cream and
the corresponding vehicle in patients with seborrhoeic dermatitis.
Design and setting: The study was conducted as a multicentre,
prospective, randomised, double-blind, parallel-group comparison at
five centres in Germany.
Patients: 165 patients with clinically diagnosed seborrhoeic
dermatitis participated in the study.
Interventions: Each patient applied ciclopiroxolamine 1% cream,
ketoconazole 2% cream or the vehicle of the former cream once daily
as a thin film to the affected skin areas for 28 days. In case of
complete resolution, treatment was terminated prematurely.
Results: Clinical response rates were significantly higher with
ciclopiroxolamine than with vehicle (in the intention-to-treat
population: 81.8% vs 59.6%, p = 0.013; in the per-protocol
population: 78.7% vs 57.7%, p = 0.032). The response rate in the
ketoconazole group was 73.6% with regard to the intention-to-treat
population and 57.7% with regard to the per-protocol population.
Treatment with ciclopiroxolamine reduced the sum score of the
clinical signs of seborrhoeic dermatitis to a greater extent than did
vehicle (p = 0.0001). Differences between the treatment groups with
regard to recurrence rates were not statistically significant.
Ciclopiroxolamine was well tolerated; adverse events assumed to be
treatment-related were detected clinically in only one of 55 patients
(1.8%).
Conclusions: This study demonstrates for the first time, using
confirmatory data analysis, that topical treatment with
ciclopiroxolamine is effective and well tolerated in patients with
seborrhoeic dermatitis.
Introduction
Since the first description of seborrhoeic dermatitis by Unna in
1887, the excessive presence of lipophilic yeasts on the skin surface
has been considered to play an important role in the pathogenesis and
maintenance of this disease.[1,2] Current evidence suggests that an
inflammatory response to Pityrosporum ovale is the direct cause of
seborrhoeic dermatitis.[3] There are conflicting data suggesting
either a toxic or an immunological mechanism: on the one hand,
Pityrosporum yeasts produce a number of potential irritants; on the
other hand, killed organisms can induce clinical changes similar to
those in seborrhoeic dermatitis.[4] As the disease has been shown to
be more common in patients with the human immunodeficiency virus
(HIV) infection,[5] alterations in the function of the immune system
have been proposed as possible pathogenetic factors.[4]
Antimycotic treatment of seborrhoeic dermatitis decreases the number
of fungal elements and, in parallel, reduces clinical signs of
inflammation.[2,6-8] In particular, ketoconazole in a cream base or
as a shampoo has been proven to be effective. Several clinical trials
have demonstrated the efficacy of other azole antimycotics, such as
miconazole, bifonazole and econazole, in seborrhoeic dermatitis.[4,9-
13] Recently, Dupuy et al.[14] demonstrated in a randomised, vehicle-
controlled, double-blind study the efficacy of ciclopiroxolamine
cream 1% in seborrhoeic dermatitis of the face. Response rates in the
ciclopiroxolamine group and in the vehicle group were compared with
each other in an explorative way, i.e. after conducting the study. In
contrast, in the present study response rates were compared with each
other in a confirmatory way, i.e. the null hypothesis H0 = ‘There is
no difference between ciclopiroxolamine cream 1% and the
corresponding vehicle with regard to response rates’, had been
formulated before clinical trial was conducted. The aim of this study
was to investigate the efficacy and safety of ciclopiroxolamine
compared with ketoconazole and the corresponding cream vehicle in
seborrhoeic dermatitis. When defining the trial plan for the study,
it was decided to assess the improvement of the disease during
treatment by clinical evaluation. Recently, Piérard-Franchimont et al.
[15] chose colony counts of Pityrosporum ovale as a variable for the
efficacy of topical drugs against seborrhoeic dermatitis.