RosaceaPhase 3NCT02289352
Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea
A Phase 3 study testing Brimonidine in people with Rosacea, run by Actavis Inc. at 16 sites in United States.
Trial summary
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Brimonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2014to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Females of child bearing potential must not be pregnant or lactating at Screening and Randomization (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate form of birth control.
- All females will be considered to be of childbearing potential unless they:
- Are post-menopausal, defined as women who have been amenorrheic for at least 12 consecutive months, without other known or suspected primary cause.
- Have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior to Screening. Tubal ligation will not be considered a surgically sterile method.
Show all 15Show fewer
- Female patients of childbearing potential are defined as:
- Women without prior hysterectomy, or who have had any evidence of menses in the past 12 months.
- Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
- Have a clinical diagnosis of facial rosacea and fewer than 3 inflammatory lesions on the face at Screening and at Randomization (before drug application on Day 1).
- Have moderate to severe facial erythema according to both CEA and PSA (i.e., an erythema score of 3 or more for each of the CEA and PSA) at Screening and at Randomization (before drug application on Day 1).
- Free from any systemic or dermatologic disorder (other than rosacea) that, in the opinion of the Investigator, will interfere with the study evaluations or increase the risk of AEs.
- Willing to minimize external factors that might trigger rosacea flare-ups (e.g., hot environments, prolonged sun exposure, strong winds and emotional stress) within 24 hours of the Screening and Randomization visit.
- Any skin type or race, providing the skin pigmentation will allow discernment of erythema.
- Willingness and capability to cooperate to the extent and degree required by the protocol.
Who cannot join
- Patients with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses similar to rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia, that are present on the face (i.e., 5 areas: chin, nose, both cheeks, and forehead), that in the opinion of the Investigator would interfere with study evaluations.
- Have 3 or more facial inflammatory lesions of rosacea.
- Have an erythema score of 2 (mild), 1 (almost clear), or 0 (clear) on the CEA and/or the PSA at Screening and at Randomization (before drug application on Day 1).
- Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
- Patients with moderate to severe telangiectasial masses in the 5 areas of the entire face: forehead, chin, nose and each cheek, that would interfere with study evaluations.
- History of hypersensitivity or allergy to Mirvaso® including the active ingredient brimonidine tartarate or other component within the formulation.
Show all 18Show fewer
- Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization.
- Exposed to excessive ultraviolet (UV) radiation within 1 week before screening or randomization visit and/or patient was unwilling to refrain from excessive exposure to UV radiation during the course of the study.
- History of blood dyscrasia.
- Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression, or any other condition causing uncontrolled blood flow or blood pressure.
- 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.
- Patients with severe, unstable or uncontrolled cardiovascular disease.
- Patients who meet study restrictions at Screening and Randomization and/or unwillingness to comply with all restricted treatments
- Receipt of any drug as part of a research study within 30 days before dosing.
- Employees of the research center or Investigator.
- Previous participation in this study.
- Patients who are unable and/or unwilling to follow the study requirements, and procedures.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Investigator site 1
Albuquerque, New Mexico, 87106
Investigator site 11
Beachwood, Ohio, 44122
Investigator site 3
Carmel, Indiana, 46032
Investigator site 13
College Station, Texas, 77845
Investigator site 14
Fridley, Minnesota, 55432
Investigator site 15
Henderson, Nevada, 89052
Investigator site 10
High Point, North Carolina, 27262
Investigator site 2
Hot Springs, Arkansas, 71913
Investigator site 12
Houston, Texas, 77055
Investigator site 16
Long Beach, California, 90813
Investigator site 9
Louisville, Kentucky, 40202
Investigator site 5
Miami, Florida, 33015
Investigator site 7
Miami, Florida, 33175
Investigator site 8
Miramar, Florida, 33027
Investigator site 4
Nashville, Tennessee, 37215
Investigator site 6
Ormond Beach, Florida, 32174
About this study
Official title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (Brimonidine) Topical Gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients With Moderate to Severe Facial Erythema Associated With Rosacea
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema Associated with Rosacea
Read the detailed description
Up to 462 patients 18 years of age and older, with confirmed clinical diagnosis of rosacea will be enrolled to have 413 in the modified intent-to-treat (mITT) population and 371 in the per-protocol (PP) population. Patients should have fewer than 3 facial inflammatory lesions, and moderate to severe erythema according to both Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA).
- Conditions
- Rosacea
- Being tested
- Brimonidine, placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrimonidineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| brimonidine 0.33% gel | Experimental | Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) Receives: Drug: Brimonidine |
| Mirvaso gel | Active comparator | Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) Receives: Drug: Brimonidine |
| Placebo | Placebo comparator | Topical gel base only (Watson Laboratories Inc., USA) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Percentage of Treatment Success on Day 7
Percentage of patients with a clinical response of treatment success on Day 7 (± 1). Treatment success is defined as at least a 2-grade improvement on both CEA and PSA scores from baseline (pre-dose) on Day 7 (± 1) to 6 hours post-application on Day 7 (± 1).
Measured: 7 days
Secondary outcomes (1)
Percentage of Patients With a Clinical Response of Treatment Success on Day 1
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Watson Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Nageshwar R Thudi, Ph.D., Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289352
- Sponsor's protocol ID
- 71304906
- Status last verified
- Jan 2020
- First submitted
- 31 Oct 2014
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (Brimonidine) Topical Gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients With Moderate to Severe Facial Erythema Associated With Rosacea
- ClinicalTrials.gov ID
- NCT02289352
- Acronym / sponsor ID
- 71304906
- Conditions
- Rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Collaborators
- Watson Laboratories, Inc.
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Posted 14 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema Associated with Rosacea
Detailed description
Up to 462 patients 18 years of age and older, with confirmed clinical diagnosis of rosacea will be enrolled to have 413 in the modified intent-to-treat (mITT) population and 371 in the per-protocol (PP) population. Patients should have fewer than 3 facial inflammatory lesions, and moderate to severe erythema according to both Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| brimonidine 0.33% gel | Experimental | Drug: BrimonidineBrimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) |
| Mirvaso gel | Active comparator | Drug: BrimonidineMirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) |
| Placebo | Placebo comparator | Drug: placeboTopical gel base only (Watson Laboratories Inc., USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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.
- Females of child bearing potential must not be pregnant or lactating at Screening and Randomization (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate form of birth control.
- Have a clinical diagnosis of facial rosacea and fewer than 3 inflammatory lesions on the face at Screening and at Randomization (before drug application on Day 1).
- Have moderate to severe facial erythema according to both CEA and PSA (i.e., an erythema score of 3 or more for each of the CEA and PSA) at Screening and at Randomization (before drug application on Day 1).
Key exclusion criteria (18 listed)
- Patients with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses similar to rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia, that are present on the face (i.e., 5 areas: chin, nose, both cheeks, and forehead), that in the opinion of the Investigator would interfere with study evaluations.
- Have 3 or more facial inflammatory lesions of rosacea.
- Have an erythema score of 2 (mild), 1 (almost clear), or 0 (clear) on the CEA and/or the PSA at Screening and at Randomization (before drug application on Day 1).
- Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
- Patients with moderate to severe telangiectasial masses in the 5 areas of the entire face: forehead, chin, nose and each cheek, that would interfere with study evaluations.
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 |
|---|---|---|
| Brimonidine | Drug | Mirvaso gel, brimonidine 0.33% gel |
| placebo | Drug | Placebo |
Primary outcome
Primary: Percentage of Treatment Success on Day 7
Time frame: 7 days
Percentage of patients with a clinical response of treatment success on Day 7 (± 1). Treatment success is defined as at least a 2-grade improvement on both CEA and PSA scores from baseline (pre-dose) on Day 7 (± 1) to 6 hours post-application on Day 7 (± 1).
1 secondary outcome
Percentage of Patients With a Clinical Response of Treatment Success on Day 1
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rosacea
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
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
Rosacea, Rosacea, Erythematotelangiectatic
Recruiting
Rosacea Radiofrequency Microneedling
Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic
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.
Nageshwar R Thudi, Ph.D. study director
Actavis Inc.
16 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 Brimonidine in people with Rosacea, run by Actavis Inc. at 16 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 15 inclusion and 18 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary: Percentage of Treatment Success on Day 7 (time frame: 7 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 14 Jan 2020.