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Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

Primary Purpose

Skin Alterations Associated With Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Sertaconazole 2% cream
Placebo
Sponsored by
Spirig Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Alterations Associated With Atopic Dermatitis focused on measuring Skin alterations, Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
  • Universitätsklinikum Münster, Klinik für Hautkrankheiten

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sertaconazole 2% cream

Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Patient Global Assessment (PGA)

Secondary Outcome Measures

Change in Eczema Area and Severity Index (EASI)
Change in Dermatology Life Quality Index (DLQI)
Change in Patient Benefit Index (PBI)

Full Information

First Posted
February 13, 2013
Last Updated
May 19, 2015
Sponsor
Spirig Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01792713
Brief Title
Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spirig Pharma Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Alterations Associated With Atopic Dermatitis
Keywords
Skin alterations, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertaconazole 2% cream
Arm Type
Active Comparator
Arm Description
2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up
Intervention Type
Drug
Intervention Name(s)
Sertaconazole 2% cream
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Patient Global Assessment (PGA)
Time Frame
day 1, day 28
Secondary Outcome Measure Information:
Title
Change in Eczema Area and Severity Index (EASI)
Time Frame
day 1, day 28
Title
Change in Dermatology Life Quality Index (DLQI)
Time Frame
d1, d28
Title
Change in Patient Benefit Index (PBI)
Time Frame
day 1, day 28
Other Pre-specified Outcome Measures:
Title
Change in Transepidermal water loss (TEWL)
Time Frame
d1, d14, d28, d42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik für Hautkrankheiten
City
Münster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26527564
Citation
Stander S, Metz M, Ramos F MH, Maurer M, Schoepke N, Tsianakas A, Zeidler C, Luger TA. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability. Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268.
Results Reference
derived

Learn more about this trial

Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

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