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- Klinische proef NCT00871208
Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy
Randomized, Placebo-Controlled Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids vs. Low-Potency Corticosteroid Mono-therapy
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Background: Atopic dermatitis is a pruritic skin disorder which affects more than 10% of the United States population, one-third of whom report sleep disturbance and a quarter with chronic unremitting disease. Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and extensive costs for the health care system. Quality of life is often impaired for patients with atopic dermatitis due to sleep disturbance, pruritus and the physical impairment of visible skin lesions.
The rapidity in which pruritus and lesional appearance are noted to resolve correlates strongly with improved patient satisfaction and improved quality of life.
Recently, a clinical trial of adding mupirocin into a regimen of topical corticosteroids has shown a significant enhancement in lesional clearance and symptom reduction with addition of mupirocin to the topical corticosteroid. These improvements were most notable within the first week of treatment.
Proposal: A 4-week clinical trial of 60 atopic dermatitis patients (ages 9 months to 17 years) would be conducted. All sixty patients would be given topical mid-potency corticosteroid (Locoid lipocream®) to be mixed with a second product. Half the patients would receive Altabax® and the other half would receive vehicle (blinded to subject and investigator). Patients would be advised to apply the topical randomized product first, let dry and then apply topical Locoid lipocream ® to affected areas, and then apply the topical randomized ointment product to each of the sites of skin disease on top of the Locoid lipocream ®. Treatment of affected areas would continue for 4 weeks or until lesions have cleared, which ever comes first. Parents of patients will be asked to maintain a written diary of drug application.
Studietype
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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New York
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NY, New York, Verenigde Staten, 10003
- Department of Dermatology, Beth Israel Medical Center
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NY, New York, Verenigde Staten, 10019
- Department of Dermatology, Roosevelt Hospital
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NY, New York, Verenigde Staten, 10025
- Department of Dermatology, St. Luke's-Roosevelt-Hospital Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Diagnosis of Atopic Dermatitis
- Ages 9 months to 17 years
- Presence of at least one lesion of atopic dermatitis at the time of baseline enrollment
- Disease limited to less than 100 cm2 body surface area
- EASI Score of at least 7, based on the Gong, et al publication Gong JQ, Lin L, Lin T, Hao F, Zeng FQ, Bi ZG, Yi D, Zhao B. Skin colonization by Staphylococcus aureus in patients with eczema and atopic dermatitis and relevant combined topical therapy: a double-blind multicentre randomized controlled trial. Br J Dermatol. 2006 Oct;155(4):680-7.
Exclusion Criteria:
- Allergy to any ingredient in Altabax® or Locoid lipocream ®
- Usage of oral corticosteroids within the 2 weeks prior to study initiation or during the study
- Usage of topical corticosteroid or other topical prescriptions for atopic dermatitis in the week prior to study initiation
- Inability to comply with the study protocol
- Presence of major medical illness requiring systemic therapy including cancers.
- Clinical diagnosis of bacterial infections of the skin, including impetigo or abscesses.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
Altabax (R) and Locoid Lipocream (R):Patients will apply both drugs sequentially to active lesions of atopic dermatitis.
Physical examination, skin cultures, photos and quality of life scores will be performed at baseline, week 1, week 2 and week 4.
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Retapamulin 1% ointment is to be applied to lesional atopic dermatitis twice-daily in addition to a topical corticosteroid (Locoid lipocream (R))
Andere namen:
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Actieve vergelijker: 2
Vehicle and Locoid Lipocream (R):Patients will apply both drugs sequentially to active lesions of atopic dermatitis.
Physical examination, skin cultures, photos and quality of life scores will be performed at baseline, week 1, week 2 and week 4.
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The vehicle base of retapamulin ointment will be applied twice-daily to active lesions of atopic dermatitis in addition to locoid lipocream (R)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Superiority of drug to vehicle in reducing Eczema Area and Severity Index (EASI) scores in children with atopic dermatitis
Tijdsspanne: Each patient will be enrolled for a 4 week trial
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Each patient will be enrolled for a 4 week trial
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Improved quality of life with usage of the drug altabax (R) and topical corticosteroids over vehicle and topical corticosteroids for treatment of atopic dermatitis in children with atopic dermatitis.
Tijdsspanne: 4 week trial of medication
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4 week trial of medication
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Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Algemene publicaties
- Fivenson D, Arnold RJ, Kaniecki DJ, Cohen JL, Frech F, Finlay AY. The effect of atopic dermatitis on total burden of illness and quality of life on adults and children in a large managed care organization. J Manag Care Pharm. 2002 Sep-Oct;8(5):333-42. doi: 10.18553/jmcp.2002.8.5.333.
- Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x.
- Ricci G, Bendandi B, Bellini F, Patrizi A, Masi M. Atopic dermatitis: quality of life of young Italian children and their families and correlation with severity score. Pediatr Allergy Immunol. 2007 May;18(3):245-9. doi: 10.1111/j.1399-3038.2006.00502.x.
- Gong JQ, Lin L, Lin T, Hao F, Zeng FQ, Bi ZG, Yi D, Zhao B. Skin colonization by Staphylococcus aureus in patients with eczema and atopic dermatitis and relevant combined topical therapy: a double-blind multicentre randomized controlled trial. Br J Dermatol. 2006 Oct;155(4):680-7. doi: 10.1111/j.1365-2133.2006.07410.x.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Ziekten van het immuunsysteem
- Overgevoeligheid, Onmiddellijk
- Genetische ziekten, aangeboren
- Huidziekten, genetisch
- Overgevoeligheid
- Huidziekten, Eczeem
- Dermatitis
- Eczeem
- Dermatitis, atopisch
- Anti-infectieuze middelen
- Ontstekingsremmende middelen
- Dermatologische middelen
- Antibacteriële middelen
- Hydrocortison
- Hydrocortison 17-butyraat 21-propionaat
- Hydrocortison-acetaat
- Hydrocortison hemisuccinaat
- Retapamuline
- Hydrocortison-17-butyraat
Andere studie-ID-nummers
- SLR08-057-111672
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Klinische onderzoeken op Atopische dermatitis
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Steven BakerVoltooidNeem contact op met dermatitis van de handVerenigde Staten
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BayerVoltooid
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University of Nove de JulhoAdriana da Silva MagalhaesIngetrokkenIncontinentie geassocieerde dermatitis | Luieruitslag | FotobiomodulatietherapieBrazilië
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MC2 TherapeuticsVoltooidFototoxiciteitVerenigde Staten
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Michele SayagVoltooidFototoxiciteitFrankrijk
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Herbarium Laboratorio Botanico LtdaVoltooid
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NHS TaysideVoltooid
Klinische onderzoeken op Altabax (R)
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The University of Texas Health Science Center,...GlaxoSmithKlineVoltooidFolliculitis | Impetigo | Secundair geïnfecteerd eczeem | Lichte weke delen infectiesVerenigde Staten
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University of California, IrvineAgency for Healthcare Research and Quality (AHRQ)VoltooidMeticilline-resistente Staphylococcus AureusVerenigde Staten
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Ochsner Health SystemGlaxoSmithKline; Tulane University School of MedicineIngetrokkenMethicilline-resistente Staphylococcus AureusVerenigde Staten
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Bay Pines VA Healthcare SystemIngetrokkenOrthopedische procedures | Methicilline-resistente Staphylococcus AureusVerenigde Staten
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Derm Research, PLLCGlaxoSmithKlineVoltooidAtopische dermatitis | Secundaire infectieVerenigde Staten
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Klinikum NürnbergOnbekendZiek sinussyndroomDuitsland
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University of California, Los AngelesNational Institute of Allergy and Infectious Diseases (NIAID)Voltooid
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LifeScanVoltooid
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Daping Hospital and the Research Institute of Surgery...Nog niet aan het werven
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Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Nog niet aan het werven