Clinical trial NCT03052348: Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Active Comparator in Atopic Dermatitis.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Atopic Dermatitis
Keywords: Topical Antibiotics
Fusidic Acid
Atopic Dermatitis
Eczema
Lead sponsor: Red Cross War Memorial Childrens Hospital
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 78
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fusidic acid, polyethylene glycol hexadecyl ether \& Betamethasone valerate cream 0.1%
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participants must have a parent/legally authorized representative, who is able to give informed consent and willing and able to comply with all the required study procedures. Assent is required from children who in the investigator's judgement, are capable of understanding the nature of the study.
* Participants must have have AD as defined by the UK Working Party Criteria
* Participants can be female or male, older than 2 years but younger than 10 years (up to their 10th birthday)
* Participants must not be on systemic antibiotics treatment at recruitment
* Participants must have a baseline SCORAD score of 50 or above (severe AD)
* Participants must be eligible for second line treatment agents for AD (systemic or photo therapy)

Exclusion Criteria:

* Participants must not be systemic agents (e.g. immunosuppressive) for AD
* Participants must not be younger than 2 years or over 10 years in age.
* Participants must not be using g bleach baths as a staphylococcus eradication measure at the time of enrollment,
* Participants must not have mild-moderate AD (SCORAD\< 50)
* Participants must not be immune-compromised with AD
* Participants must not be on photo therapy for AD
* Participants must not be using wet wrap therapy for AD

Primary outcomes:
measure: SCORAD scores
timeFrame: 20 weeks
Secondary outcomes:
measure: Infants Dermatitis' Quality of Life (IDQOL) index
timeFrame: 20 weeks
measure: Frequency of AD relapse episodes
timeFrame: 20 Weeks
measure: Time to AD Relapse
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Mthatha
country: South Africa
facility: Nelson Mandela Academic Hospital
state: Eastern Cape
city: Durban
country: South Africa
facility: King Edward Hospital
state: KwaZulu Natal
city: Cape Town
country: South Africa
facility: Red Cross War Memorial Children's Hospital
state: Western Cape
Study officials:
affiliation: Red Cross Children's War Memorial Hospital
name: Dr Carol Hlela, MBCHB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sidbury R, Tom WL, Bergman JN, Cooper KD, Silverman RA, Berger TG, Chamlin SL, Cohen DE, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Eichenfield LF. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33. doi: 10.1016/j.jaad.2014.08.038. Epub 2014 Sep 26.
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citation: Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
citation: Langan SM, Thomas KS, Williams HC. What is meant by a "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006 Sep;142(9):1190-6. doi: 10.1001/archderm.142.9.1190.
citation: Totte JE, van der Feltz WT, Hennekam M, van Belkum A, van Zuuren EJ, Pasmans SG. Prevalence and odds of Staphylococcus aureus carriage in atopic dermatitis: a systematic review and meta-analysis. Br J Dermatol. 2016 Oct;175(4):687-95. doi: 10.1111/bjd.14566. Epub 2016 Jul 5.
citation: Nakamura Y, Oscherwitz J, Cease KB, Chan SM, Munoz-Planillo R, Hasegawa M, Villaruz AE, Cheung GY, McGavin MJ, Travers JB, Otto M, Inohara N, Nunez G. Staphylococcus delta-toxin induces allergic skin disease by activating mast cells. Nature. 2013 Nov 21;503(7476):397-401. doi: 10.1038/nature12655. Epub 2013 Oct 30.