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Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

NCT ID: NCT00565279

Last Updated: 2008-06-03

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

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

Brief Summary

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A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug that acts through a modulation of neurogenic inflammation through important complementary mechanisms of action. This study will test the efficacy and safety of ASF1057 in the treatment of patients with seborrhoeic dermatitis.

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Detailed Description

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Conditions

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Seborrheic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ASF1057

Group Type EXPERIMENTAL

ASF1057

Intervention Type DRUG

Twice daily, topical

ASF1057

Intervention Type DRUG

Twice daily, Topical

ASF1057 placebo

Group Type PLACEBO_COMPARATOR

ASF1057

Intervention Type DRUG

Twice daily, topical

ASF1057

Intervention Type DRUG

Twice daily, Topical

ASF1057 Vehicle

Group Type PLACEBO_COMPARATOR

ASF1057

Intervention Type DRUG

Twice daily, topical

Interventions

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ASF1057

Twice daily, topical

Intervention Type DRUG

ASF1057

Twice daily, Topical

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of moderate to severe seborrhoeic dermatitis

Exclusion Criteria

* Other active skin diseases
* Use of certain systemic and topical treatments
* Extensive sun exposure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astion Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Astion Pharma A/S

Principal Investigators

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Peder M Andersen, MD

Role: STUDY_DIRECTOR

Astion Pharma A/S

Other Identifiers

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ASF1057-301

Identifier Type: -

Identifier Source: org_study_id

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