Efficacy and Safety of ASF1057 in the Treatment of Seborr... | NCT00565279

Studies
Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

NCT00565279

Sponsor

Astion Pharma A/S

Status

Completed

Last Update Posted

Jun 3, 2008Estimated

Enrollment

300Estimated

Phase

Phase 3

Conditions

Seborrheic Dermatitis

Interventions

ASF1057
ASF1057

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

May 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Nov 28, 2007

First Submission Date that Met QC Criteria

Nov 28, 2007

First Posted Date

Nov 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2008

Last Update Posted Date

Jun 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ASF1057	Experimental	Drug: ASF1057
ASF1057 placebo	Placebo Comparator	Drug: ASF1057
ASF1057 Vehicle	Placebo Comparator	Drug: ASF1057

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASF1057	Drug	Twice daily, topical	ASF1057 ASF1057 Vehicle ASF1057 placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of responders, defined as patients with OSS ≤ 1 score units.		Baseline, day 7, day 14, and day 21

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peder M Andersen, MD	Astion Pharma A/S	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012628	Dermatitis, Seborrheic

Ancestor Terms

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided