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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group R | Active Comparator | Polyethylene glycol hexadecyl ether & betamethasone valerate cream 0.1% . ( 4 applications per day for 14 days treatment to taper fortnightly) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% | Other | Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infants Dermatitis' Quality of Life (IDQOL) index | Improvement in the Infants Dermatitis' Quality of Life (IDQOL) index in group (A) patients compared to that of the control group (R) at the end of the study compared to baseline | 20 weeks |
| Frequency of AD relapse episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Carol Hlela, MBCHB | Contact | 0741724141 | carol.hlela@uct.ac.za | |
| Dr Richard Aron, MBCHB | Contact | 021 4225 999 | richardaron06@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Carol Hlela, MBCHB | Red Cross Children's War Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nelson Mandela Academic Hospital | Mthatha | Eastern Cape | 5099 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25264237 | Background | 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. | |
| 17007538 |
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Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%
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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.
|
| 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 |
|
|
Comparison of the frequency of AD relapse episodes in group (A) patients compared to the frequency of relapse episodes in control group (R) patients. |
| 20 Weeks |
| Time to AD Relapse | Comparison of the time to AD relapse episodes in group (A) patients compared to the time to relapse episodes in control group (R) patients. | 20 weeks |
| King Edward Hospital | Durban | KwaZulu-Natal | 4013 | South Africa |
|
| Red Cross War Memorial Children's Hospital | Cape Town | Western Cape | 7700 | South Africa |
| 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. |
| 19403473 | 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. |
| 16983006 | 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. |
| 26994362 | 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. |
| 24172897 | 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. |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002592 | Cetomacrogol |
| D005672 | Fusidic Acid |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002775 | Cholestadienols |
| D002774 | Cholestadienes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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