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Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

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.
ClinicalTrials.gov Identifier: NCT00565279
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : June 3, 2008
Sponsor:
Information provided by:
Astion Pharma A/S

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.

Condition or disease Intervention/treatment Phase
Seborrheic Dermatitis Drug: ASF1057 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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.
Study Start Date : December 2007
Primary Completion Date : May 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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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

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

Responsible Party: Dr Peder Andersen, Astion Pharma A/S
ClinicalTrials.gov Identifier: NCT00565279     History of Changes
Other Study ID Numbers: ASF1057-301
First Posted: November 29, 2007    Key Record Dates
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