NCT03052348

Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Active Comparator in Atopic Dermatitis.

Status unknown NA Last updated 25 September 2017

What this trial tests

NA trial testing Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% in Severe Atopic Dermatitis in 78 participants. Status unknown.

Timeline

1 November 2017

Primary endpoint
30 July 2018

30 August 2018

Quick facts

Lead sponsor	Red Cross War Memorial Childrens Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	78
Start date	1 November 2017
Primary completion	30 July 2018
Estimated completion	30 August 2018
Sites	3 locations across South Africa

Drugs / interventions tested

• Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%
• Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%

Conditions studied

• Severe Atopic Dermatitis — all drugs for Severe Atopic Dermatitis →

Sponsor

Red Cross War Memorial Childrens Hospital

Who can join

Adults 2 to 10, any sex, with Severe Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions to reduce Staphylococcus aureus in the management of eczema.
   George SM, Karanovic S, Harrison DA, Rani A, et al · · 2019 · cited 27× · PMID 31684694 · DOI 10.1002/14651858.cd003871.pub3