Papulopustular RosaceaPhase 3NCT02393937
A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea
A Phase 3 study testing Reference: Metronidazole Gel 1% and Test: Metronidazole Gel 1% in people with Papulopustular Rosacea and Erythematotelangiectatic Rosacea, run by bioRASI, LLC at 27 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea, Erythematotelangiectatic Rosacea
- What is being tested?
- Reference: Metronidazole Gel 1% and Test: Metronidazole Gel 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 963 participants
- Where
- 27 sitesUnited States
- Study dates
- Feb 2015to Oct 2015
- 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
- Male or Female subjects with at least 18 years of age;
- Read and signed ICF;
- Clinical Diagnosis of Rosacea;
Who cannot join
- Females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception;
- Any skin condition that would interfere with treatment of rosacea
- Use of prohibited medications
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Study site
Arlington, Virginia, 22203
Study site
Austin, Texas, 78759
Study site
Boca Raton, Florida, 33486
Study site
Cincinnati, Ohio, 45246
Study site
Clearwater, Florida, 33761
Study site
El Paso, Texas, 79902
Study site
High Point, North Carolina, 27262
Study site
Houston, Texas, 77055
Study site
Las Vegas, Nevada, 89104
Study site
Lexington, Kentucky, 40509
Study site
Los Angeles, California, 90036
Study site
Miami, Florida, 33126
Study site
Miami, Florida, 33136
Study site
Miramar, Florida, 33027q
Study site
Mt. Pleasant, South Carolina, 29464
Study site
New York, New York, 10075
Study site
Norfolk, Virginia, 23507
Study site
Ocala, Florida, 34471
Study site
Pflugerville, Texas, 78660
Study site
Philadelphia, Pennsylvania, 19103
Study site
Plano, Texas, 75093
Study site
Raleigh, North Carolina, 27612
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92121
Study site
Tampa, Florida, 33634
Study site
Warwick, Rhode Island, 02886
Study site
Watertown, Massachusetts, 02472
About this study
Official title: A Multi-center, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Metronidazole Gel 1%, to Metrogel® (Metronidazole Gel) 1% in the Treatment of Rosacea
The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.
- Being tested
- Reference: Metronidazole Gel 1%, Test: Metronidazole Gel 1%, Placebo Gel
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference: Metronidazole Gel 1%Drug
Also called MetroGel
Participants are assigned to one of three groups in parallel for the duration of the study
Test: Metronidazole Gel 1%Drug
Participants are assigned to one of three groups in parallel for the duration of the study
Placebo GelDrug
Participants are assigned to one of three groups in parallel for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Test: Metronidazole Gel 1% | Experimental | Metronidazole Gel 1% once daily for 70 days. Receives: Drug: Test: Metronidazole Gel 1% |
| Reference: Metronidazole Gel 1% | Active comparator | Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days. Receives: Drug: Reference: Metronidazole Gel 1% |
| Placebo | Placebo comparator | Placebo Gel once daily for 70 days. Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea.
Measured: 70 Days
Secondary outcomes (1)
To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity
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 posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular 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
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioRASI, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393937
- Sponsor's protocol ID
- LO-17-3-2014
- Status last verified
- Nov 2016
- First submitted
- 12 Mar 2015
- Last updated
- 3 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Metronidazole Gel 1%, to Metrogel® (Metronidazole Gel) 1% in the Treatment of Rosacea
- ClinicalTrials.gov ID
- NCT02393937
- Acronym / sponsor ID
- LO-17-3-2014
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- bioRASI, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Mar 2015 (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 compare the efficacy of two Metronidazole Gels 1%, in the treatment of 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 |
|---|---|---|
| Test: Metronidazole Gel 1% | Experimental | Drug: Test: Metronidazole Gel 1%Metronidazole Gel 1% once daily for 70 days. |
| Reference: Metronidazole Gel 1% | Active comparator | Drug: Reference: Metronidazole Gel 1%Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days. |
| Placebo | Placebo comparator | Drug: Placebo GelPlacebo Gel once daily for 70 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female subjects with at least 18 years of age;
- Read and signed ICF;
- Clinical Diagnosis of Rosacea;
Key exclusion criteria (3 listed)
- Females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception;
- Any skin condition that would interfere with treatment of rosacea
- Use of prohibited medications
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 |
|---|---|---|
| Reference: Metronidazole Gel 1%Also: MetroGelParticipants are assigned to one of three groups in parallel for the duration of the study | Drug | Reference: Metronidazole Gel 1% |
| Test: Metronidazole Gel 1%Participants are assigned to one of three groups in parallel for the duration of the study | Drug | Test: Metronidazole Gel 1% |
| Placebo GelParticipants are assigned to one of three groups in parallel for the duration of the study | Drug | Placebo |
Primary outcome
To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea.
Time frame: 70 Days
1 secondary outcome
To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity
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 3 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reference: Metronidazole Gel 1% and Test: Metronidazole Gel 1% in people with Papulopustular Rosacea and Erythematotelangiectatic Rosacea, run by bioRASI, LLC at 27 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 3 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 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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?
To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea. (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 3 Sep 2020.