NCT00565279

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 3, 2008

Status Verified

June 1, 2008

Enrollment Period

5 months

First QC Date

November 28, 2007

Last Update Submit

June 2, 2008

Conditions

Seborrheic Dermatitis

Keywords

Seborrhoeic dermatitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of responders, defined as patients with OSS ≤ 1 score units.

    Baseline, day 7, day 14, and day 21

Study Arms (3)

ASF1057

EXPERIMENTAL
Drug: ASF1057

ASF1057 placebo

PLACEBO COMPARATOR
Drug: ASF1057

ASF1057 Vehicle

PLACEBO COMPARATOR
Drug: ASF1057

Interventions

ASF1057DRUG

Twice daily, topical

ASF1057ASF1057 VehicleASF1057 placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of moderate to severe seborrhoeic dermatitis

You may not qualify if:

  • Other active skin diseases
  • Use of certain systemic and topical treatments
  • Extensive sun exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSkin Diseases, EczematousSkin Diseases, Papulosquamous

Study Officials

  • Peder M Andersen, MD

    Astion Pharma A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

December 1, 2007

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

June 3, 2008

Record last verified: 2008-06