Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis - Full Text View

Sponsored by:	Astion Pharma A/S
Information provided by:	Astion Pharma A/S
ClinicalTrials.gov Identifier:	NCT00565279

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
ASF1057: Experimental	Drug: ASF1057 Twice daily, topical Drug: ASF1057 Twice daily, Topical
ASF1057 placebo: Placebo Comparator	Drug: ASF1057 Twice daily, topical Drug: ASF1057 Twice daily, Topical
ASF1057 Vehicle: Placebo Comparator	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

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

Keywords provided by Astion Pharma A/S:

Seborrhoeic dermatitis

Study placed in the following topic categories:

Dermatitis, Seborrheic
Skin Diseases
Skin Diseases, Eczematous

Sebaceous Gland Diseases
Skin Diseases, Papulosquamous
Dermatitis

Additional relevant MeSH terms:

Dermatitis, Seborrheic
Skin Diseases
Skin Diseases, Eczematous

Sebaceous Gland Diseases
Skin Diseases, Papulosquamous
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009