Erythemato-telangiectatic RosaceaPhase 2NCT01449591
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients
A Phase 2 study testing BFH772 1% ointment and Noritate® 1% cream in people with Erythemato-telangiectatic Rosacea, run by Novartis Pharmaceuticals at 6 sites in United States.
Trial summary
This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erythemato-telangiectatic Rosacea
- What is being tested?
- BFH772 1% ointment and Noritate® 1% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2011to Feb 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have persistent facial erythema on the cheeks of at least moderate severity.
- Women must not be able to bear children
Who cannot join
- Have more than 12 inflammatory lesions on the face
- Previous treatment of facial skin with lasers or electrocauterisation within 2 months prior to entering the study
- Have facial hair that makes it difficult to evaluate rosacea on the face Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Novartis Investigative Site
Ann Arbor, Michigan
Novartis Investigative Site
Austin, Texas
Novartis Investigative Site
Hot Springs, Arkansas
Novartis Investigative Site
Paramus, New Jersey
Novartis Investigative Site
Portland, Oregon
Novartis Investigative Site
Spokane, Washington
About this study
Official title: A Proof of Concept (PoC) Study to Evaluate the Safety, Tolerability, and Efficacy of 12 Week Administration of BFH772 Ointment in Rosacea Patients
This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.
- Conditions
- Erythemato-telangiectatic Rosacea
- Being tested
- BFH772 1% ointment, Vehicle ointment, Noritate® 1% cream
- Keywords
- BFH772, rosacea, erythemato-telangiectatic rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFH772 1% ointmentDrug
Vehicle ointmentDrug
Noritate® 1% creamDrug
| Study group | Role | What they receive |
|---|---|---|
| BFH772 | Experimental | Not described Receives: Drug: BFH772 1% ointment |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle ointment |
| Metronidazole | Active comparator | Not described Receives: Drug: Noritate® 1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score
Measured: 12 weeks
Secondary outcomes (2)
To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score
Measured: 12 weeks
To measure blood levels of BFH772 in patients
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 posted10 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythemato-telangiectatic RosaceaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449591
- Sponsor's protocol ID
- CBFH772A2203
- Status last verified
- Feb 2021
- First submitted
- 19 Sep 2011
- Last updated
- 21 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept (PoC) Study to Evaluate the Safety, Tolerability, and Efficacy of 12 Week Administration of BFH772 Ointment in Rosacea Patients
- ClinicalTrials.gov ID
- NCT01449591
- Acronym / sponsor ID
- CBFH772A2203
- Conditions
- Erythemato-telangiectatic Rosacea
- Keywords
- BFH772, rosacea, erythemato-telangiectatic rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Oct 2011 (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 will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BFH772 | Experimental | Drug: BFH772 1% ointment |
| Vehicle | Placebo comparator | Drug: Vehicle ointment |
| Metronidazole | Active comparator | Drug: Noritate® 1% cream |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have persistent facial erythema on the cheeks of at least moderate severity.
- Women must not be able to bear children
Key exclusion criteria (3 listed)
- Have more than 12 inflammatory lesions on the face
- Previous treatment of facial skin with lasers or electrocauterisation within 2 months prior to entering the study
- Have facial hair that makes it difficult to evaluate rosacea on the face Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| BFH772 1% ointment | Drug | BFH772 |
| Vehicle ointment | Drug | Vehicle |
| Noritate® 1% cream | Drug | Metronidazole |
Primary outcome
To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score
Time frame: 12 weeks
2 secondary outcomes
To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score
Time frame: 12 weeks
To measure blood levels of BFH772 in patients
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 21 Feb 2021.
- Results for CBFH772A2203 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 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 BFH772 1% ointment and Noritate® 1% cream in people with Erythemato-telangiectatic Rosacea, run by Novartis Pharmaceuticals at 6 sites 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 2 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score (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 21 Feb 2021.