Severe Atopic Dermatitis Clinical Trial
Official title:
A Multicentre Study Evaluating the Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Standard of Care in the Treatment of Severe Atopic Dermatitis, a Phase II Randomized, Clinical Trial
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that occurs most
commonly during early infancy and childhood. It is frequently associated with abnormalities
in skin barrier function, allergen sensitization and recurrent skin infections. AD is a major
public health problem worldwide, with prevalence in children of 10-20% and 2-5% of the
general population. The skin of AD patients is susceptible to colonization and infection with
Staphylococcus aureus (SA )which contribute significantly to the severity of the clinical
manifestations of eczema, triggering a vicious cycle.
Fusidic Acid (FA) cream is a topical antibiotic widely used in the treatment of skin and soft
tissue infections and infected atopic dermatitis. However in recent years, the emergence of
drug-resistant organisms, e.g. Methicillin- resistant Staphylococcus aureus (MRSA) has led to
scrutiny of antibiotic use. Prolonged use of topical FA has been linked with emergence of
FA-resistant Staphylococcus aureus (FRSA) . Fusidic acid is a natural antibiotic, extracted
from cultures of Fusidium coccineum, which has a powerful antibacterial action. Topical use
of Fusidic acid is fully in line with therapeutic strategies that recommend the use of an
antibiotic with the narrowest activity spectrum to minimize the risk of resistance. In AD
with infected lesions, combined treatment with antibiotic and steroid demonstrates greater
efficacy over the use of steroid.
Trial Design: A three-center, double blind, randomized ,phase II , parallel group, efficacy
trial.
Type of Intervention: A triple compounded cream containing a topical antibiotic , topical
steroid and moisturizer.
Type of control: Active control containing a double compounded cream comprising a topical
steroid and moisturizer .
Study population and Setting: A sample of 78 subjects will be recruited from Red Cross
Children's Hospital , Nelson Mandela Academic Hospital and King Edward Hospital Estimated
duration of trial: 12 months. Duration of participation: Each subject will participate in the
trial for a maximum of 140 days.
Primary endpoint: reduction in SCORAD scores; frequency of clinical flares for AD and
improvement in the quality of life at 140 days.
The benefit of this trial is that it provides a simple and effective approach to the
management of atopic eczema.
n/a
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