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Completed

NCT Number: NCT01792713

Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

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

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Key information

Conditions

Skin Alterations Associated With Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertaconazole 2% cream

Drug

Placebo

Drug

Primary outcomes

  1. Change in Patient Global Assessment (PGA)

    Time frame: day 1, day 28

Secondary outcomes

  1. Change in Eczema Area and Severity Index (EASI)

    Time frame: day 1, day 28

  2. Change in Dermatology Life Quality Index (DLQI)

    Time frame: d1, d28

  3. Change in Patient Benefit Index (PBI)

    Time frame: day 1, day 28

Other outcomes

  1. Change in Transepidermal water loss (TEWL)

    Time frame: d1, d14, d28, d42

Sponsors and collaborators

Lead sponsor

Spirig Pharma Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 15, 2013
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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