Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis
NCT ID: NCT01792713
Last Updated: 2015-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2013-02-28
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sertaconazole 2% cream
2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up
Sertaconazole 2% cream
Placebo Arm
2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up
Placebo
Interventions
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Sertaconazole 2% cream
Placebo
Eligibility Criteria
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Inclusion Criteria
* Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40
* Atopic lesion localisation: arms; additional legs, neck
Exclusion Criteria
* Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
* Active immunosuppression or cancer
* Narcotics- or Alcohol abuse
* Participation in another clinical trial until one month prior inclusion
* Known allergies against an ingredient of the investigational medicinal product
* Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs
* Pregnancy or lactation
18 Years
75 Years
ALL
No
Sponsors
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Spirig Pharma Ltd.
INDUSTRY
Responsible Party
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Locations
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Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
Berlin, , Germany
Universitätsklinikum Münster, Klinik für Hautkrankheiten
Münster, , Germany
Countries
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References
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Stander S, Metz M, Ramos F MH, Maurer M, Schoepke N, Tsianakas A, Zeidler C, Luger TA. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability. Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268.
Other Identifiers
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2012-003954-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E550-PRU-2012
Identifier Type: -
Identifier Source: org_study_id
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