Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

May 19, 2015 updated by: Spirig Pharma Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
      • Münster, Germany, 48149
        • Universitätsklinikum Münster, Klinik fur Hautkrankheiten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sertaconazole 2% cream
2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up
Drug: Sertaconazole 2% cream
Placebo Comparator: Placebo Arm
2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Patient Global Assessment (PGA)
Time Frame: day 1, day 28
day 1, day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Eczema Area and Severity Index (EASI)
Time Frame: day 1, day 28
day 1, day 28
Change in Dermatology Life Quality Index (DLQI)
Time Frame: d1, d28
d1, d28
Change in Patient Benefit Index (PBI)
Time Frame: day 1, day 28
day 1, day 28

Other Outcome Measures

Outcome Measure
Time Frame
Change in Transepidermal water loss (TEWL)
Time Frame: d1, d14, d28, d42
d1, d14, d28, d42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spirig Pharma Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E550-PRU-2012
  • 2012-003954-95 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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