Completed

Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)

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What is being tested

Sertaconazole 2% cream

+ Placebo

Drug
Who is being recruted

Dermatitis+8

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorSpirig Pharma Ltd.
Last updated: May 20, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis

NCT01792713
Principal SponsorSpirig Pharma Ltd.
Last updated: May 20, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, InbornDermatitis, Atopic

Criteria

Inclusion Criteria: Informed consent Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40 Atopic lesion localisation: arms; additional legs, neck Exclusion Criteria: SCORAD > 40 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up

Group II

Placebo
2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie

Berlin, GermanyOpen Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie in Google Maps

Universitätsklinikum Münster, Klinik für Hautkrankheiten

Münster, Germany
Completed2 Study Centers