Inflammatory RosaceaPhase 3NCT01016782
Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea
A Phase 3 study testing 0444 in people with Inflammatory Rosacea, run by Fougera Pharmaceuticals Inc..
Trial summary
The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea. Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Rosacea
- What is being tested?
- 0444
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 867 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jul 2009
- 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 rosacea
- Good health with the exception of rosacea
- Papsules and pustules minimum and maximum requirements
Who cannot join
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of rosacea
About this study
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel
The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.
Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.
- Conditions
- Inflammatory Rosacea
- Being tested
- 0444
- Keywords
- Inflammatory Rosacea, Rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0444Drug
A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Test product that contains active pharmaceutical ingredient Receives: Drug: 0444 |
| Reference | Active comparator | Reference product that contains active pharmaceutical ingredient Receives: Drug: 0444 |
| Vehicle | Placebo comparator | Placebo that contains no active pharmaceutical ingredient Receives: Drug: 0444 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of papules and pustules from Baseline to End of Treatment
Measured: 70 Days
Secondary outcomes (1)
Reduction in the Investigator's Global Evaluation, Clear or Almost Clear
Measured: 70 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory RosaceaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 867 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fougera Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela C Kaplan, Study director, Fougera Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016782
- Sponsor's protocol ID
- 0444
- Status last verified
- Jul 2014
- First submitted
- 17 Nov 2009
- Last updated
- 4 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel
- ClinicalTrials.gov ID
- NCT01016782
- Acronym / sponsor ID
- 0444
- Conditions
- Inflammatory Rosacea
- Keywords
- Inflammatory Rosacea, Rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 867 participants (actual)
- Lead sponsor
- Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Nov 2009 (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 aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.
Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.
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 |
|---|---|---|
| Test | Experimental | Drug: 0444Test product that contains active pharmaceutical ingredient |
| Reference | Active comparator | Drug: 0444Reference product that contains active pharmaceutical ingredient |
| Vehicle | Placebo comparator | Drug: 0444Placebo that contains no active pharmaceutical ingredient |
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 rosacea
- Good health with the exception of rosacea
- Papsules and pustules minimum and maximum requirements
Key exclusion criteria (2 listed)
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of rosacea
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 |
|---|---|---|
| 0444A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days | Drug | Reference, Test, Vehicle |
Primary outcome
Reduction in the number of papules and pustules from Baseline to End of Treatment
Time frame: 70 Days
1 secondary outcome
Reduction in the Investigator's Global Evaluation, Clear or Almost Clear
Time frame: 70 Days
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 4 Jul 2014.
Related trials for Inflammatory Rosacea
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Atopic Dermatitis, Psoriasis
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.
Angela C Kaplan study director
Fougera Pharmaceuticals Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0444 in people with Inflammatory Rosacea, run by Fougera Pharmaceuticals Inc..
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 2 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 4 Jul 2014. 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?
Reduction in the number of papules and pustules from Baseline to End of Treatment (time frame: 70 Days). 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 4 Jul 2014.