Rosacea, PapulopustularPhase 4NCT03418610
Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea
A Phase 4 study testing Azelaic Acid foam 15% in people with Rosacea, Papulopustular, run by Clinical Research Center of the Carolinas at 1 site in United States.
Trial summary
This research study is being performed to evaluate the photographic evidence of the efficacy and tolerability of Azelaic Acid Foam 15% in the treatment of papulopustular rosacea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Papulopustular
- What is being tested?
- Azelaic Acid foam 15%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2017to 9 Jan 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects age 18 or older.
- Diagnosis of moderate to severe papulopustular rosacea with IGA of 3- moderate or 4-severe.
- Presence of 12 - 50 inflammatory lesions and persistent erythema with or without telangiectasia.
- Subjects must read, understand, and sign the Informed Consent.
- Subjects must be willing and able to comply with study procedures and visit schedule requirements.
- Women of childbearing potential that are willing to use an acceptable method of contraception during the study.
Who cannot join
- Active or localized or systemic infections.
- Subjects must not be immunocompromised.
- Known unresponsiveness or allergy to azelaic acid.
- Subjects unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g. drug or alcohol abuse).
- Subjects must not be pregnant or breastfeeding.
- Presence of dermatoses that might interfere with the ability to diagnose and/or evaluate rosacea.
Show all 14Show fewer
- Presence of other types of rosacea.
- Laser surgery on the face for the treatment of telangiectasia or other conditions within 6 weeks of study enrollment.
- Use of medications or products for the treatment of rosacea or other medical conditions within the following time periods prior to study enrollment. Use of these medications will be prohibited during the trial.
- Topical Prescription or Nonprescription medications 6 weeks Oral retinoids 6 months Tetracycline (ex. doxycycline, minocycline 2 months Corticosteroids 4 weeks Erythromycin or azithromycin 4 weeks Other systemic medications to treat rosacea 6 weeks
- Refusal to sign the Informed Consent document or Photo Release document and/or refusal to comply with all follow-up requirements.
- Use of medications that are known to cause flushing.
- Dose changes in the last 90 days or initiation of beta-blockers, vasodilators, vasoconstrictors, nonsteroidal anti-inflammatory drugs, hormone therapy, and/or other drugs known to cause acneform eruptions.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
About this study
Official title: Azelaic Acid Foam 15% in the Treatment of Papulopustula Rosacea: An Evaluation of Photographic Evidence
This research study is being performed to evaluate the photographic evidence of the efficacy and tolerability of Azelaic Acid Foam 15% in the treatment of papulopustular rosacea.
Read the detailed description
This is a single site, single arm open label study of Azelaic Acid foam 15% for the treatment of moderate to severe papulopustular rosacea. All patients will apply Azelaic Acid foam twice daily. At scheduled visits, high resolution equipment will be used to measure 3D topographical values for elevation of papules and pustules to objectively evaluate reduction of papulopustular lesions. Investigator and subject assessments will also be completed to assess the level of rosacea at weeks 4,8 and 12.
- Conditions
- Rosacea, Papulopustular
- Being tested
- Azelaic Acid foam 15%
- Keywords
- Rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic Acid foam 15%Drug
Also called Finacea
mild to moderate rosacea
| Study group | Role | What they receive |
|---|---|---|
| Open Label Single Arm | Other | Azelaic Acid Foam 15% applied twice daily Receives: Drug: Azelaic Acid foam 15% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Lesion Count
The change in inflammatory lesion counts at week 12 compared to baseline
Measured: 12 weeks
Secondary outcomes (1)
Investigator Global Assessment
Severity of Disease by Investigator Global Assessment, Score of 0 (Clear) - 4(Severe)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start6 Dec 2017
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rosacea, PapulopustularStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Site, Single Arm Open Label Study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center of the Carolinas
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Todd Schlesinger, MD, FAAD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418610
- Sponsor's protocol ID
- Bayer Rosacea
- Status last verified
- Jan 2018
- First submitted
- 12 Dec 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azelaic Acid Foam 15% in the Treatment of Papulopustula Rosacea: An Evaluation of Photographic Evidence
- ClinicalTrials.gov ID
- NCT03418610
- Acronym / sponsor ID
- Bayer Rosacea
- Conditions
- Rosacea, Papulopustular
- Keywords
- Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Clinical Research Center of the CarolinasUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 1 Feb 2018 (actual)
- 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 research study is being performed to evaluate the photographic evidence of the efficacy and tolerability of Azelaic Acid Foam 15% in the treatment of papulopustular rosacea.
Detailed description
This is a single site, single arm open label study of Azelaic Acid foam 15% for the treatment of moderate to severe papulopustular rosacea. All patients will apply Azelaic Acid foam twice daily. At scheduled visits, high resolution equipment will be used to measure 3D topographical values for elevation of papules and pustules to objectively evaluate reduction of papulopustular lesions. Investigator and subject assessments will also be completed to assess the level of rosacea at weeks 4,8 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Site, Single Arm Open Label Study
| Arm | Type | Receives |
|---|---|---|
| Open Label Single Arm | Other | Drug: Azelaic Acid foam 15%Azelaic Acid Foam 15% applied twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects age 18 or older.
- Diagnosis of moderate to severe papulopustular rosacea with IGA of 3- moderate or 4-severe.
- Presence of 12 - 50 inflammatory lesions and persistent erythema with or without telangiectasia.
- Subjects must read, understand, and sign the Informed Consent.
- Subjects must be willing and able to comply with study procedures and visit schedule requirements.
Key exclusion criteria (14 listed)
- Active or localized or systemic infections.
- Subjects must not be immunocompromised.
- Known unresponsiveness or allergy to azelaic acid.
- Subjects unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g. drug or alcohol abuse).
- Subjects must not be pregnant or breastfeeding.
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 foam 15%Also: Finaceamild to moderate rosacea | Drug | Open Label Single Arm |
Primary outcome
Inflammatory Lesion Count
Time frame: 12 weeks
The change in inflammatory lesion counts at week 12 compared to baseline
1 secondary outcome
Investigator Global Assessment
Time frame: 12 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 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Todd Schlesinger, MD, FAAD principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azelaic Acid foam 15% in people with Rosacea, Papulopustular, run by Clinical Research Center of the Carolinas at 1 site in United States.
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 6 inclusion and 14 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Inflammatory Lesion Count (time frame: 12 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 24 Jul 2019.