Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

Skin Alterations Associated With Atopic Dermatitis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792713
• Other study ID #: E550-PRU-2012
• Secondary ID: 2012-003954-95
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2013
• Last updated: May 19, 2015
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Spirig Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Skin Alterations Associated With Atopic Dermatitis

Intervention

Drug:
• Sertaconazole 2% cream

• Placebo

Locations

Country	Name	City	State
Germany	Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie	Berlin
Germany	Universitätsklinikum Münster, Klinik für Hautkrankheiten	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Spirig Pharma Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Transepidermal water loss (TEWL)		d1, d14, d28, d42	No
Primary	Change in Patient Global Assessment (PGA)		day 1, day 28	No
Secondary	Change in Eczema Area and Severity Index (EASI)		day 1, day 28	No
Secondary	Change in Dermatology Life Quality Index (DLQI)		d1, d28	No
Secondary	Change in Patient Benefit Index (PBI)		day 1, day 28	No