Back to resultsEfficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis
Primary Purpose
Seborrheic Dermatitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ASF1057
ASF1057
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Dermatitis focused on measuring Seborrhoeic dermatitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
ASF1057
ASF1057 placebo
ASF1057 Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Proportion of responders, defined as patients with OSS ≤ 1 score units.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00565279
Brief Title
Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis
Official Title
Efficacy and Safety of ASF 1057 Cream 0.5% in the Treatment of Seborrhoeic Dermatitis: A Phase III Randomised, Double-Blind, Vehicle and Placebo Controlled, Parallel Groups, Multi-Centre Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astion Pharma A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
Keywords
Seborrhoeic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASF1057
Arm Type
Experimental
Arm Title
ASF1057 placebo
Arm Type
Placebo Comparator
Arm Title
ASF1057 Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ASF1057
Intervention Description
Twice daily, topical
Intervention Type
Drug
Intervention Name(s)
ASF1057
Intervention Description
Twice daily, Topical
Primary Outcome Measure Information:
Title
Proportion of responders, defined as patients with OSS ≤ 1 score units.
Time Frame
Baseline, day 7, day 14, and day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peder M Andersen, MD
Organizational Affiliation
Astion Pharma A/S
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis
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