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Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565279
First Posted: November 29, 2007
Last Update Posted: June 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astion Pharma A/S
  Purpose
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.

Condition Intervention Phase
Seborrheic Dermatitis Drug: ASF1057 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Astion Pharma A/S:

Primary Outcome Measures:
  • Proportion of responders, defined as patients with OSS ≤ 1 score units. [ Time Frame: Baseline, day 7, day 14, and day 21 ]

Estimated Enrollment: 300
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASF1057 Drug: ASF1057
Twice daily, topical
Drug: ASF1057
Twice daily, Topical
Placebo Comparator: ASF1057 placebo Drug: ASF1057
Twice daily, topical
Drug: ASF1057
Twice daily, Topical
Placebo Comparator: ASF1057 Vehicle Drug: ASF1057
Twice daily, topical

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565279


Sponsors and Collaborators
Astion Pharma A/S
Investigators
Study Director: Peder M Andersen, MD Astion Pharma A/S
  More Information

Responsible Party: Dr Peder Andersen, Astion Pharma A/S
ClinicalTrials.gov Identifier: NCT00565279     History of Changes
Other Study ID Numbers: ASF1057-301
First Submitted: November 28, 2007
First Posted: November 29, 2007
Last Update Posted: June 3, 2008
Last Verified: June 2008

Keywords provided by Astion Pharma A/S:
Seborrhoeic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous