- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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New York
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NY, New York, Vereinigte Staaten, 10003
- Department of Dermatology, Beth Israel Medical Center
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NY, New York, Vereinigte Staaten, 10019
- Department of Dermatology, Roosevelt Hospital
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NY, New York, Vereinigte Staaten, 10025
- Department of Dermatology, St. Luke's-Roosevelt-Hospital Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Superiority of drug to vehicle in reducing Eczema Area and Severity Index (EASI) scores in children with atopic dermatitis
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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.
Zeitfenster: 4 week trial of medication
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4 week trial of medication
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Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Hautkrankheiten
- Erkrankungen des Immunsystems
- Überempfindlichkeit, sofort
- Genetische Krankheiten, angeboren
- Hautkrankheiten, genetisch
- Überempfindlichkeit
- Hautkrankheiten, Ekzem
- Dermatitis
- Ekzem
- Dermatitis, atopisch
- Antiinfektiva
- Entzündungshemmende Mittel
- Dermatologische Wirkstoffe
- Antibakterielle Mittel
- Hydrocortison
- Hydrocortison-17-butyrat-21-propionat
- Hydrocortisonacetat
- Hydrocortisonhemisuccinat
- Retapamulin
- Hydrocortison-17-butyrat
Andere Studien-ID-Nummern
- SLR08-057-111672
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Atopische Dermatitis
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Hadassah Medical OrganizationUnbekannt
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BayerAbgeschlossen
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MC2 TherapeuticsAbgeschlossenPhototoxizitätVereinigte Staaten
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Michele SayagAbgeschlossenPrävention von Phototoxizitäten bei Patienten, die sich einer Behandlung mit Vemurafenib unterziehenPhototoxizitätFrankreich
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Herbarium Laboratorio Botanico LtdaAbgeschlossen
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University of Nove de JulhoAdriana da Silva MagalhaesZurückgezogenInkontinenz-assoziierte Dermatitis | Windelausschlag | PhotobiomodulationstherapieBrasilien
Klinische Studien zur Altabax (R)
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The University of Texas Health Science Center,...GlaxoSmithKlineAbgeschlossenFollikulitis | Impetigo | Sekundär infiziertes Ekzem | Kleinere WeichteilinfektionenVereinigte Staaten
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University of California, IrvineAgency for Healthcare Research and Quality (AHRQ)AbgeschlossenMethicillin-resistenter Staphylococcus AureusVereinigte Staaten
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Ochsner Health SystemGlaxoSmithKline; Tulane University School of MedicineZurückgezogenMethicillin-resistenter Staphylococcus AureusVereinigte Staaten
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Bay Pines VA Healthcare SystemZurückgezogenOrthopädische Verfahren | Methicillin-resistenter Staphylococcus AureusVereinigte Staaten
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Derm Research, PLLCGlaxoSmithKlineAbgeschlossenAtopische Dermatitis | SekundärinfektionVereinigte Staaten
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Klinikum NürnbergUnbekanntSick-Sinus-SyndromDeutschland
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University of California, Los AngelesNational Institute of Allergy and Infectious Diseases (NIAID)AbgeschlossenInfektionen der Atemwege | Grippe | ImpfungenVereinigte Staaten
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LifeScanAbgeschlossen
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Daping Hospital and the Research Institute of Surgery...Noch keine Rekrutierung
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Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Noch keine Rekrutierung