Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Astion Pharma A/S
ClinicalTrials.gov Identifier:
NCT00565279
First received: November 28, 2007
Last updated: June 2, 2008
Last verified: June 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565279

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

No publications provided

Responsible Party: Dr Peder Andersen, Astion Pharma A/S
ClinicalTrials.gov Identifier: NCT00565279     History of Changes
Other Study ID Numbers: ASF1057-301
Study First Received: November 28, 2007
Last Updated: June 2, 2008
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on July 31, 2014