Seborrheic DermatitisPhase 3NCT00565279
Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis
A Phase 3 study testing ASF1057 in people with Seborrheic Dermatitis, run by Astion Pharma A/S.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- ASF1057
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of moderate to severe seborrhoeic dermatitis
Who cannot join
- Other active skin diseases
- Use of certain systemic and topical treatments
- Extensive sun exposure
About this 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.
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
- Seborrheic Dermatitis
- Being tested
- ASF1057
- Keywords
- Seborrhoeic dermatitis
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASF1057Drug
Twice daily, topical
ASF1057Drug
Twice daily, Topical
| Study group | Role | What they receive |
|---|---|---|
| ASF1057 | Experimental | Not described Receives: Drug: ASF1057 |
| ASF1057 placebo | Placebo comparator | Not described Receives: Drug: ASF1057 |
| ASF1057 Vehicle | Placebo comparator | Not described Receives: Drug: ASF1057 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders, defined as patients with OSS ≤ 1 score units.
Measured: Baseline, day 7, day 14, and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astion Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peder M Andersen, MD, Study director, Astion Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565279
- Sponsor's protocol ID
- ASF1057-301
- Status last verified
- Jun 2008
- First submitted
- 28 Nov 2007
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00565279
- Acronym / sponsor ID
- ASF1057-301
- Conditions
- Seborrheic Dermatitis
- Keywords
- Seborrhoeic dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Astion Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASF1057 | Experimental | Drug: ASF1057 |
| ASF1057 placebo | Placebo comparator | Drug: ASF1057 |
| ASF1057 Vehicle | Placebo comparator | Drug: ASF1057 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of moderate to severe seborrhoeic dermatitis
Key exclusion criteria (3 listed)
- Other active skin diseases
- Use of certain systemic and topical treatments
- Extensive sun exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASF1057Twice daily, topical | Drug | ASF1057, ASF1057 Vehicle, ASF1057 placebo |
| ASF1057Twice daily, Topical | Drug | ASF1057, ASF1057 placebo |
Primary outcome
Proportion of responders, defined as patients with OSS ≤ 1 score units.
Time frame: Baseline, day 7, day 14, and day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peder M Andersen, MD study director
Astion Pharma A/S
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASF1057 in people with Seborrheic Dermatitis, run by Astion Pharma A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders, defined as patients with OSS ≤ 1 score units. (time frame: Baseline, day 7, day 14, and day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2008.