RosaceaPhase 3NCT02385240
Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea
A Phase 3 study testing Brimonidine Topical Gel, 0.33 percent (Perrigo) and Brimonidine Topical Gel, 0.33 percent (Reference) in people with Rosacea, run by Padagis LLC.
Trial summary
To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved rosacea drug product in the treatment of facial erythema of 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?
- Brimonidine Topical Gel, 0.33 percent (Perrigo) and Brimonidine Topical Gel, 0.33 percent (Reference)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- 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
- Provide IRB approved written informed consent/assent.
- Male or non-pregnant female, ≥ 18 years of age.
- Diagnosis of rosacea with moderate to severe erythema on the face defined as: a score of ≥ 3 on the Clinician's Erythema Assessment (CEA) and a score of ≥ 3 on the Patient's Self-Assessment (PSA) on Visit 1/Day 1 (Baseline) prior to the first application of study medication at hour 0.
- Willing and able to understand and comply with the requirements of the study.
- Be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
- Females of childbearing potential in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study
Who cannot join
- Females who are pregnant, breast feeding, or planning a pregnancy within the study participation period.
- Presence of three (3) or more facial inflammatory lesions of rosacea.
- 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.
- Other facial conditions that in the Investigator's opinion might interfere with a rosacea diagnosis and/or assessment including but not limited to: acne conglobata, acne fulminans, rhinophyma, facial pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, actinic keratosis, acne, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis .
- Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in the judgment of the Investigator, would put the subject at undue risk or might confound the study assessments (such as planned hospitalization during the study).
- Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
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- Excessive facial hair (such as beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea.
- History of hypersensitivity or allergy to any ingredient in the study medication.
- Previous enrollment in this study.
- Non-responders to prior treatment with topical brimonidine.
- Currently using any product containing brimonidine tartrate or oxymetazoline.
- Start or change of dose of hormonal treatments.
- Start or change of dose of tricyclic or tetracyclic antidepressants, cardio glycosides, beta blockers or calcium channel blockers or other anti-hypertensive agents 3 months (90 days) prior to baseline or throughout the study. Use of such therapy must remain constant during the study.
- Current treatment with or start of any of the following class of drugs: monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics or alpha-agonists, medicines for psychosis, medicines for hyperactivity
- Use within 6 months (180 days) prior to baseline or during the study of oral retinoids or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- Use within 12 weeks (84 days) prior to baseline or during the study of systemic immunomodulators
- Use of medicated make-up throughout the study and/or significant change in the use of consumer products within 4 weeks (28 days) of study entry and throughout the study.
- Participation in any clinical study involving an investigational product or device in the 4 weeks (28 days) prior to baseline or throughout the study.
- Use of following topicals on the face within 14 days prior to baseline or during the study of antibiotics and/or prescription anti-inflammatory agents including ophthalmic
- Over the counter (OTC) topical anti-acne medications 7 days prior to baseline
- Chronic, daily use of OTC anti-inflammatory medications for more than 7 days (does not include low-dose aspirin for cardiac prophylaxis), 7 days prior to baseline and throughout the study. Subjects may use acetaminophen for pain relief, as needed throughout the study.
- Use of tanning booths, sun lamps, sunbathing, phototherapy or excessive ultraviolet (UV) exposure to the sun 7 days prior to baseline and throughout the study.
- Use of Niacin ≥500 mg per day within 7 days of study start and throughout the study.
- Use of topical astringents or abrasives within 2 days of study start and throughout the study.
- Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming, etc.) within 24 hours of all study visits (Visit 1 through Visit 3).
About this study
To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved rosacea drug product in the treatment of facial erythema of rosacea.
- Conditions
- Rosacea
- Being tested
- Brimonidine Topical Gel, 0.33 percent (Perrigo), Brimonidine Topical Gel, 0.33 percent (Reference), 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.
Brimonidine Topical Gel, 0.33 percent (Perrigo)Drug
Also called Perrigo product
Brimonidine Topical Gel, 0.33 percent (Reference)Drug
Also called Reference Listed Drug Product
Placebo gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Brimonidine Topical Gel, 0.33 percent Receives: Drug: Brimonidine Topical Gel, 0.33 percent (Perrigo) |
| Reference Product | Active comparator | Brimonidine Topical Gel, 0.33 percent (Reference) Receives: Drug: Brimonidine Topical Gel, 0.33 percent (Reference) |
| Placebo gel | Placebo comparator | Placebo Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Composite Success
2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales
Measured: Day 15 at hour 6
Secondary outcomes (2)
Proportion of Subjects With Composite Success
2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales
Measured: Day 15 at hour 3
Proportion of Subjects With Composite Success
2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales
Measured: Day 15 at hour 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
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
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385240
- Sponsor's protocol ID
- PRG-NY-14-022
- Status last verified
- Oct 2021
- First submitted
- 5 Mar 2015
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea
- ClinicalTrials.gov ID
- NCT02385240
- Acronym / sponsor ID
- PRG-NY-14-022
- Conditions
- Rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 14 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved rosacea drug product in the treatment of facial erythema of rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: Brimonidine Topical Gel, 0.33 percent (Perrigo)Brimonidine Topical Gel, 0.33 percent |
| Reference Product | Active comparator | Drug: Brimonidine Topical Gel, 0.33 percent (Reference)Brimonidine Topical Gel, 0.33 percent (Reference) |
| Placebo gel | Placebo comparator | Drug: Placebo gelPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide IRB approved written informed consent/assent.
- Male or non-pregnant female, ≥ 18 years of age.
- Diagnosis of rosacea with moderate to severe erythema on the face defined as: a score of ≥ 3 on the Clinician's Erythema Assessment (CEA) and a score of ≥ 3 on the Patient's Self-Assessment (PSA) on Visit 1/Day 1 (Baseline) prior to the first application of study medication at hour 0.
- Willing and able to understand and comply with the requirements of the study.
- Be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
Key exclusion criteria (25 listed)
- Females who are pregnant, breast feeding, or planning a pregnancy within the study participation period.
- Presence of three (3) or more facial inflammatory lesions of rosacea.
- 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.
- Other facial conditions that in the Investigator's opinion might interfere with a rosacea diagnosis and/or assessment including but not limited to: acne conglobata, acne fulminans, rhinophyma, facial pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, actinic keratosis, acne, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis .
- Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in the judgment of the Investigator, would put the subject at undue risk or might confound the study assessments (such as planned hospitalization during the study).
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 Topical Gel, 0.33 percent (Perrigo)Also: Perrigo product | Drug | Test product |
| Brimonidine Topical Gel, 0.33 percent (Reference)Also: Reference Listed Drug Product | Drug | Reference Product |
| Placebo gel | Drug | Placebo gel |
Primary outcome
Proportion of Subjects With Composite Success
Time frame: Day 15 at hour 6
2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales
2 secondary outcomes
Proportion of Subjects With Composite Success
Time frame: Day 15 at hour 3
Proportion of Subjects With Composite Success
Time frame: Day 15 at hour 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brimonidine Topical Gel, 0.33 percent (Perrigo) and Brimonidine Topical Gel, 0.33 percent (Reference) in people with Rosacea, run by Padagis LLC.
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 6 inclusion and 25 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 22 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 14 Dec 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?
Proportion of Subjects With Composite Success (time frame: Day 15 at hour 6). 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 22 Oct 2021.