Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

NCT ID: NCT01792713

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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

Detailed Description

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Conditions

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Skin Alterations Associated With Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sertaconazole 2% cream

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

Group Type ACTIVE_COMPARATOR

Sertaconazole 2% cream

Intervention Type DRUG

Placebo Arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Sertaconazole 2% cream

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spirig Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie

Berlin, , Germany

Site Status

Universitätsklinikum Münster, Klinik für Hautkrankheiten

Münster, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26527564 (View on PubMed)

Other Identifiers

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2012-003954-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E550-PRU-2012

Identifier Type: -

Identifier Source: org_study_id

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