Perioral DermatitisPhase 2NCT00403949
A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
A Phase 2 study testing Azelaic acid 15% gel and Non-active base from azelaic acid 15% gel in people with Perioral Dermatitis, run by LEO Pharma at 4 sites in Germany.
Trial summary
The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioral Dermatitis
- What is being tested?
- Azelaic acid 15% gel and Non-active base from azelaic acid 15% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 4 sitesGermany
- Study dates
- Nov 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
- Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
- Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
- 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
Who cannot join
- History of atopic dermatitis of the face
- Granulomatous perioral dermatitis
- Facial acne, rosacea, facial demodicosis
- Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
- The use of topical or systemic medications that could affect the course of treatment and/or evaluation
- Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
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- Use of fluorinated toothpaste
- Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
- Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
- History of or suspected hypersensitivity to any ingredient of the study drugs
- Participation in another clinical study 4 weeks prior to and/or during the conduct of this study
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Study site
Berlin, 10827
Study site
Dülmen, 48249
Study site
Essen, 45122
Study site
Recklinghausen, 45661
About this study
Official title: A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis
The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
- Conditions
- Perioral Dermatitis
- Being tested
- Azelaic acid 15% gel, Non-active base from azelaic acid 15% gel
- Medical subject headings
- Dermatitis, Perioral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic acid 15% gelDrug
gel, applied once daily, for 6 weeks
Non-active base from azelaic acid 15% gelDrug
gel, apply once daily for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Azelaic acid 15% Gel | Active comparator | Azelaic acid 15% Receives: Drug: Azelaic acid 15% gel |
| Placebo | Placebo comparator | Non-active base from Azelaic acid 15% gel Receives: Drug: Non-active base from azelaic acid 15% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sum score derived from the most important signs and symptoms of perioral dermatitis
Measured: Measurements and observations during the course of the study
Secondary outcomes (2)
Intensity of single signs and symptoms
Measured: Measured at scheduled visits during the course of the study
Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator
Measured: Safety parameters recorded at scheduled visits during the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startNov 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 Perioral 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 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
- NCT00403949
- Sponsor's protocol ID
- 1400418
- Other IDs
- 2006-002471-40
- Status last verified
- Feb 2015
- First submitted
- 23 Nov 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 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis
- ClinicalTrials.gov ID
- NCT00403949
- Acronym / sponsor ID
- 1400418
- Conditions
- Perioral Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Nov 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Nov 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.
The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelaic acid 15% Gel | Active comparator | Drug: Azelaic acid 15% gelAzelaic acid 15% |
| Placebo | Placebo comparator | Drug: Non-active base from azelaic acid 15% gelNon-active base from Azelaic acid 15% gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
- Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
- 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
Key exclusion criteria (11 listed)
- History of atopic dermatitis of the face
- Granulomatous perioral dermatitis
- Facial acne, rosacea, facial demodicosis
- Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
- The use of topical or systemic medications that could affect the course of treatment and/or evaluation
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% gelgel, applied once daily, for 6 weeks | Drug | Azelaic acid 15% Gel |
| Non-active base from azelaic acid 15% gelgel, apply once daily for six weeks | Drug | Placebo |
Primary outcome
The sum score derived from the most important signs and symptoms of perioral dermatitis
Time frame: Measurements and observations during the course of the study
2 secondary outcomes
Intensity of single signs and symptoms
Time frame: Measured at scheduled visits during the course of the study
Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator
Time frame: Safety parameters recorded at scheduled visits during the course of the study
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.
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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.
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 Non-active base from azelaic acid 15% gel in people with Perioral Dermatitis, 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 3 inclusion and 11 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?
The sum score derived from the most important signs and symptoms of perioral dermatitis (time frame: Measurements and observations during the course of the study). 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.