Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

Phase 2

Completed

• Conditions: Skin Alterations Associated With Atopic Dermatitis
• Interventions: Drug: Sertaconazole 2% cream; Drug: Placebo

• Registration Number: NCT01792713
• Lead Sponsor: Spirig Pharma Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2013-09
• Study Completion: 2014-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertaconazole 2% cream	Sertaconazole 2% cream	2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up
Placebo Arm	Placebo	2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up

Primary Outcome Measures

Name	Time	Method
Change in Patient Global Assessment (PGA)	day 1, day 28

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Universitätsklinikum Münster, Klinik für Hautkrankheiten; 🇩🇪 Münster, Germany

Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie; 🇩🇪 Berlin, Germany