## Protocol Section
### Identification Module
**NCT ID:** 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.

#### Organization Study ID Info
**ID:** ASF1057-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Astion Pharma A/S
### Status Module
#### Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-06-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-06-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-05

**Type:** ACTUAL

#### Start Date
**Date:** 2007-12

**Status Verified Date:** 2008-06

#### Study First Post Date
**Date:** 2007-11-29
**Type:** ESTIMATED
**Study First Submit Date:** 2007-11-28
**Study First Submit QC Date:** 2007-11-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Astion Pharma A/S

#### Responsible Party

**Old Name Title:** Dr Peder Andersen

**Old Organization:** Astion Pharma A/S

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Seborrheic Dermatitis

**Keywords:**

- Seborrhoeic dermatitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: ASF1057

**Label:** ASF1057

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: ASF1057

**Label:** ASF1057 placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Drug: ASF1057

**Label:** ASF1057 Vehicle

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ASF1057

- ASF1057 Vehicle

- ASF1057 placebo

**Description:** Twice daily, topical

**Name:** ASF1057

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ASF1057

- ASF1057 placebo

**Description:** Twice daily, Topical

**Name:** ASF1057

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Proportion of responders, defined as patients with OSS ≤ 1 score units.

**Time Frame:** Baseline, day 7, day 14, and day 21

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Astion Pharma A/S

**Name:** Peder M Andersen, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000012625

- Term: Sebaceous Gland Diseases

- ID: D000017443

- Term: Skin Diseases, Eczematous

- ID: D000017444

- Term: Skin Diseases, Papulosquamous

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7067

- Name: Dermatitis

- Relevance: HIGH

- As Found: Dermatitis

- ID: M15442

- Name: Dermatitis, Seborrheic

- Relevance: HIGH

- As Found: Seborrhoeic Dermatitis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15439

- Name: Sebaceous Gland Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19712

- Name: Skin Diseases, Eczematous

- Relevance: LOW

- As Found: Unknown

- ID: M19713

- Name: Skin Diseases, Papulosquamous

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003872

- Term: Dermatitis

- ID: D000012628

- Term: Dermatitis, Seborrheic

### Misc Info Module

#### Removed Countries

- Country: Denmark

- Version Holder: 2024-05-24
