RosaceaPhase 1MTZGNCT01513863
A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea
A Phase 1 study testing Metronidazole Topical Gel 1% and Metronidazole Topical Gel 1% (Metrogel) in people with Rosacea, run by Sun Pharmaceutical Industries, Inc. at 22 sites in United States.
Trial summary
The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Metronidazole Topical Gel 1% and Metronidazole Topical Gel 1% (Metrogel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 602 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Phase 1
- 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 non-pregnant, non-lactating female, 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations.
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
- Have moderate to severe facial rosacea.
- Have a Baseline Investigator Global Evaluation Score of 3 or 4.
Who cannot join
- Mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions)
- Patients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
- History of hypersensitivity or allergy to Metronidazole, or other ingredients of the formulation.
- Use of oral retinoids (e.g. Accutane ®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within the 6 months prior to the baseline visit.
- Use of the following within 1 month prior to the baseline visit:
- Topical Retinoids to the face
Show all 20Show fewer
- Systemic antibiotics known to have an impact on the severity of facial Rosacea
- Systemic Steroids
- The use of anticoagulant therapy within 14 days prior to baseline.
- The use of any antipruritics, including antihistamines within 24 hours of any study visits.
- History of blood dyscrasia.
- Ocular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics.
- Any dermatological condition other than rosacea that in the Investigator's opinion may interfere with the evaluation of the Patient's rosacea (e.g., acne, psoriasis, dermatitis).
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study Patient at undue risk by participation.
- Any Patient (male or female) who has started, or changed hormonal therapy within 3 months of the Baseline visit (this includes hormonal contraceptives).
- Use of high strength (20% or above) alpha-hydroxy acid for facial peel or any type of chemical facial skin peel or other significant cosmetic procedures within 2 months of the study start.
- Receipt of any drug as part of a research study within 30 days prior to dosing.
- Employees of the research center or Investigator.
- Previous participation in this study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Investigator Site
Arlington Heights, Illinois
Investigator Site
Denver, Colorado
Investigator Site
Hazleton, Pennsylvania
Investigator Site
Henderson, Nevada
Investigator Site
Hickory, North Carolina
Investigator Site
High Point, North Carolina
Investigator Site
Jacksonville, Florida
Investigator Site
Kingsport, Tennessee
Investigator Site
Knoxville, Tennessee
Investigator Site
Long Beach, California
Investigator Site
Miami, Florida
Investigator Site
Miramar, Florida
Investigator Site
Nashville, Tennessee
Investigator Site
Newport Beach, California
Investigator Site
Phoenix, Arizona
Investigator Site
Plainfield, Indiana
Investigator Site
San Antonio, Texas
Investigator Site
Simpsonville, South Carolina
Investigator Site
South Euclid, Ohio
Investigator Site
Webster, Texas
Investigator Site
West Jordan, Utah
Investigator Site
Wilmington, North Carolina
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multi-Site Clinical Study to Compare the Bioequivalence of Two Metronidazole 1% Topical Gel Formulations in Patients With Moderate to Severe Rosacea
The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.
- Conditions
- Rosacea
- Being tested
- Metronidazole Topical Gel 1%, Metronidazole Topical Gel 1% (Metrogel), Placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole Topical Gel 1%Drug
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
Metronidazole Topical Gel 1% (Metrogel)Drug
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
PlaceboDrug
Placebo applied to affected area once a day for 70 days
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole Topical Gel 1% | Experimental | Not described Receives: Drug: Metronidazole Topical Gel 1% |
| Metronidazole Topical Gel 1% (Metrogel ) | Active comparator | Not described Receives: Drug: Metronidazole Topical Gel 1% (Metrogel) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)
Measured: Day 70
Treatment Success
A patient is considered a treatment success if the mean percent change from baseline at week 10 (Day 70) in the inflammatory (papules and pastales) lesion count of Rosacea
Measured: Day 70
Secondary outcomes (1)
Change in Investigational Global Evaluation (IGE)
Mean change from baseline to end of treatment in IGE
Measured: Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513863
- Sponsor's protocol ID
- MTZG 1101
- Acronym
- MTZG
- Status last verified
- Dec 2013
- First submitted
- 16 Jan 2012
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multi-Site Clinical Study to Compare the Bioequivalence of Two Metronidazole 1% Topical Gel Formulations in Patients With Moderate to Severe Rosacea
- ClinicalTrials.gov ID
- NCT01513863
- Acronym / sponsor ID
- MTZG / MTZG 1101
- Conditions
- Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jan 2012 (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 objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metronidazole Topical Gel 1% | Experimental | Drug: Metronidazole Topical Gel 1% |
| Metronidazole Topical Gel 1% (Metrogel ) | Active comparator | Drug: Metronidazole Topical Gel 1% (Metrogel) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant, non-lactating female, 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations.
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
- Have moderate to severe facial rosacea.
- Have a Baseline Investigator Global Evaluation Score of 3 or 4.
Key exclusion criteria (20 listed)
- Mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions)
- Patients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
- History of hypersensitivity or allergy to Metronidazole, or other ingredients of the formulation.
- Use of oral retinoids (e.g. Accutane ®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within the 6 months prior to the baseline visit.
- Use of the following within 1 month prior to the baseline visit:
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 |
|---|---|---|
| Metronidazole Topical Gel 1%Metronidazole Topical Gel 1% applied to affected area once a day for 70 days | Drug | Metronidazole Topical Gel 1% |
| Metronidazole Topical Gel 1% (Metrogel)Metronidazole Topical Gel 1% applied to affected area once a day for 70 days | Drug | Metronidazole Topical Gel 1% (Metrogel ) |
| PlaceboPlacebo applied to affected area once a day for 70 days | Drug | Placebo |
Primary outcome
Clinical Success
Time frame: Day 70
A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)
Treatment Success
Time frame: Day 70
A patient is considered a treatment success if the mean percent change from baseline at week 10 (Day 70) in the inflammatory (papules and pastales) lesion count of Rosacea
1 secondary outcome
Change in Investigational Global Evaluation (IGE)
Time frame: Day 70
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 23 Dec 2013.
Related trials for Rosacea
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metronidazole Topical Gel 1% and Metronidazole Topical Gel 1% (Metrogel) in people with Rosacea, run by Sun Pharmaceutical Industries, Inc. at 22 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 5 inclusion and 20 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 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinical Success (time frame: Day 70). The study lists 2 primary outcomes in all. 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 23 Dec 2013.