Seborrheic Dermatitis on the FacePhase 2NCT00408330
A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face
A Phase 2 study testing Azelaic Acid 15% Gel and Inactive 15% gel base in people with Seborrheic Dermatitis on the Face, run by LEO Pharma at 4 sites in Germany.
Trial summary
This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Dermatitis on the Face
- What is being tested?
- Azelaic Acid 15% Gel and Inactive 15% gel base
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2006to Mar 2007
- Phase
- Phase 2
- 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
- Stable or exacerbating seborrheic dermatitis in the facial area
Who cannot join
- Psoriasis
- Atopic dermatitis
- Facial acne and rosacea
- Dermatophytic skin infections
- Parkinson's disease
- Known immunosuppression; HIV infection
Show all 9Show fewer
- Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy
- Continuous asthma inhalation treatment requiring > 800 mg corticosteroids
- Any severe disease likely to interfere with the conduct or the planned termination of the study
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Study site
Blankenfelde-Mahlow, 15831
Study site
Buchholz, 21244
Study site
Hamburg, 20354
Study site
Hamburg, 22049
About this study
Official title: A Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face
This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.
Read the detailed description
To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face
- Conditions
- Seborrheic Dermatitis on the Face
- Being tested
- Azelaic Acid 15% Gel, Inactive 15% gel base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic Acid 15% GelDrug
15% gel, topically applied daily for six weeks
Inactive 15% gel baseDrug
placebo, topically applied daily for six weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | azelaic acid 15% Receives: Drug: Azelaic Acid 15% Gel |
| 2 | Placebo comparator | Inactive 15% gel base Receives: Drug: Inactive 15% gel base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.
Measured: Measurement of parameters during the course of treatment (six weeks)
Secondary outcomes (1)
Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms
Measured: Measurement of parameters during the course of treatment (six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic Dermatitis on the FaceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408330
- Sponsor's protocol ID
- 1401201
- Other IDs
- 2006-002060-26
- Status last verified
- Mar 2015
- First submitted
- 5 Dec 2006
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face
- ClinicalTrials.gov ID
- NCT00408330
- Acronym / sponsor ID
- 1401201
- Conditions
- Seborrheic Dermatitis on the Face
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Dec 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 6 Dec 2006 (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.
This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.
Detailed description
To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Azelaic Acid 15% Gelazelaic acid 15% |
| 2 | Placebo comparator | Drug: Inactive 15% gel baseInactive 15% gel base |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable or exacerbating seborrheic dermatitis in the facial area
Key exclusion criteria (9 listed)
- Psoriasis
- Atopic dermatitis
- Facial acne and rosacea
- Dermatophytic skin infections
- Parkinson's disease
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 |
|---|---|---|
| Azelaic Acid 15% Gel15% gel, topically applied daily for six weeks | Drug | 1 |
| Inactive 15% gel baseplacebo, topically applied daily for six weeks | Drug | 2 |
Primary outcome
Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.
Time frame: Measurement of parameters during the course of treatment (six weeks)
1 secondary outcome
Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms
Time frame: Measurement of parameters during the course of treatment (six weeks)
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 9 Jun 2023.
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.
Bayer Study Director study director
Bayer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azelaic Acid 15% Gel and Inactive 15% gel base in people with Seborrheic Dermatitis on the Face, run by LEO Pharma at 4 sites in Germany.
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 9 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment. (time frame: Measurement of parameters during the course of treatment (six weeks)). 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 9 Jun 2023.