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

NCT03052348 | Unknown

• 1 other identifier: RedCrossWMCH
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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.

Conditions

Severe Atopic Dermatitis

Keywords

Topical Antibiotics; Fusidic Acid; Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

• SCORAD scores

  Reduction of SCORAD scores in the treatment group (A) of patients comparing with scores in the control group (R), at the end of the study with reference to baseline

  20 weeks

Secondary Outcomes (3)

• Infants Dermatitis' Quality of Life (IDQOL) index

  20 weeks

• Frequency of AD relapse episodes

  20 Weeks

• Time to AD Relapse

  20 weeks

Study Arms (2)

Group R

ACTIVE COMPARATOR

Polyethylene glycol hexadecyl ether \& betamethasone valerate cream 0.1% . ( 4 applications per day for 14 days treatment to taper fortnightly)

Other: Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%

Group A

EXPERIMENTAL

Fusidic acid \& Polyethylene glycol hexadecyl ether,\& betamethasone valerate cream 0.1%). ( 4 applications per day for 14 days treatment to taper fortnightly)

Other: Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%

Interventions

Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% OTHER

Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid

Also known as: Cetomacrogol 400g, Reg No PL 00240/0014., Lenovate cream, 15g, Reg No. 27/13.4.1/0493

Group R

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

Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid Fusidic Acid - Topical Antibiotic

Also known as: Cetomacrogol 400g, Reg No PL 00240/0014., Lenovate cream, 15g, Reg No. 27/13.4.1/0493, Fusidic Acid (Fucidin cream), 15 g, Reg No. Q/20.1.6/128

Group A

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Red Cross War Memorial Childrens Hospital: lead

Study Sites (3)

Nelson Mandela Academic Hospital

Mthatha, Eastern Cape, 5099, South Africa

Location

King Edward Hospital

Durban, KwaZulu-Natal, 4013, South Africa

Location

Red Cross War Memorial Children's Hospital

Cape Town, Western Cape, 7700, South Africa

Location

Related Publications (6)

• 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.

  PMID: 25264237 BACKGROUND

• Cardona ID, Cho SH, Leung DY. Role of bacterial superantigens in atopic dermatitis : implications for future therapeutic strategies. Am J Clin Dermatol. 2006;7(5):273-9. doi: 10.2165/00128071-200607050-00001.

  PMID: 17007538 BACKGROUND

• 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.

  PMID: 19403473 BACKGROUND

• 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.

  PMID: 16983006 BACKGROUND

• 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.

  PMID: 26994362 BACKGROUND

• 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.

  PMID: 24172897 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Cetomacrogol; Fusidic Acid

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cholestadienols; Cholestadienes; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Membrane Lipids; Lipids

Study Officials

• Dr Carol Hlela, MBCHB

  Red Cross Children's War Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Carol Hlela, MBCHB

CONTACT

0741724141; carol.hlela@uct.ac.za

Dr Richard Aron, MBCHB

CONTACT

021 4225 999; richardaron06@aol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be given creams (containing either the intervention or control regimens - both white in color) in unlabelled opaque containers. Participants, investigators and the outcomes assessor evaluating the outcome of interest (SCORAD) will be blinded to the treatment allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Fusidic acid, polyethylene glycol hexadecyl ether \& Betamethasone valerate cream 0.1%

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: November 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: August 30, 2018
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

ZA (3)