Erythema and Flushing Associated With RosaceaNCT03508869
Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea
A study testing Mirvaso® (brimonidine) topical gel, 0.33%, Dysport® and Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% in people with Erythema and Flushing Associated With Rosacea, run by Skin Laser & Surgery Specialists.
Trial summary
To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythema and Flushing Associated With Rosacea
- What is being tested?
- Mirvaso® (brimonidine) topical gel, 0.33%, Dysport® and Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2016to 20 Sep 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- 18 years of age or older
- Clinical diagnosis of rosacea
- Moderate to severe persistent facial erythema associated with rosacea at baseline, as determined by: a grade of greater than or equal to 3 on the 5 point grading scale1 (Figure 1)
- No known medical conditions that may interfere with study participation
- Willingness to not use any products on their face for the duration of the study
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- Read, understand, and sign informed consent forms
- Willingness to sign photography release form
- Willing and able to comply with all follow-up requirements
- Willingness to undergo treatment using Mirvaso® Gel and Dysport®
Who cannot join
- Any significant skin disease at treatment area
- Any medical condition which could interfere with the treatment
- Inability or unwillingness to follow the treatment schedule
- Inability or unwillingness to sign the informed consent
- Pregnant or lactating
- Allergy to cow's milk protein
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- Previous or current use of Mirvaso® Gel
- Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients
- Previous Dysport® treatment 6 months prior to the screening visit
About this study
To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.
Read the detailed description
To assess the improvement of facial erythema and flushing while using Mirvaso® and Dysport® treatments based on the clinician's and patient's assessments using a verified 5-point grading scale
- Being tested
- Mirvaso® (brimonidine) topical gel, 0.33%, Dysport®, Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirvaso® (brimonidine) topical gel, 0.33%Drug
Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older.
Dysport®Drug
Also called Dysport® (abobotulinumtoxinA)
Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%Drug
Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
| Study group | Role | What they receive |
|---|---|---|
| Mirvaso® (brimonidine) topical gel, 0.33% | Active comparator | Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older. Receives: Drug: Mirvaso® (brimonidine) topical gel, 0.33% |
| Dysport® | Active comparator | Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent. Receives: Drug: Dysport® |
| Dysport® in conjunction with Mirvaso | Active comparator | Dysport® in conjunction with Mirvaso Receives: Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Assessments for Erythema
% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Erythema 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Erythema on the 5-point grading scale.
Measured: 6 months
Efficacy Assessments for Flushing
% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Flushing 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Flushing on the 5-point grading scale.
Measured: 6 months
Secondary outcomes (1)
Safety Assessments
Safety evaluations will be performed at all visits. Adverse events, local tolerability (dryness, pruritus burning/stinging) and a facial exam will be performed for all visits.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start27 Sep 2016
- Primary completion20 Sep 2017
- Study completion20 Sep 2017
Why it stopped: sponsor asked site to suspend study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythema and Flushing Associated With 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Laser & Surgery Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, David J. Goldberg, MD, Skin Laser & Surgery Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508869
- Sponsor's protocol ID
- MG-DYS-ROS
- Status last verified
- Apr 2023
- First submitted
- 19 May 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea
- ClinicalTrials.gov ID
- NCT03508869
- Acronym / sponsor ID
- MG-DYS-ROS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor asked site to suspend study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Skin Laser & Surgery SpecialistsUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 26 Apr 2018 (actual)
- 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.
To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.
Detailed description
To assess the improvement of facial erythema and flushing while using Mirvaso® and Dysport® treatments based on the clinician's and patient's assessments using a verified 5-point grading scale
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirvaso® (brimonidine) topical gel, 0.33% | Active comparator | Drug: Mirvaso® (brimonidine) topical gel, 0.33%Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older. |
| Dysport® | Active comparator | Drug: Dysport®Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent. |
| Dysport® in conjunction with Mirvaso | Active comparator | Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%Dysport® in conjunction with Mirvaso |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- 18 years of age or older
- Clinical diagnosis of rosacea
- Moderate to severe persistent facial erythema associated with rosacea at baseline, as determined by: a grade of greater than or equal to 3 on the 5 point grading scale1 (Figure 1)
- No known medical conditions that may interfere with study participation
Key exclusion criteria (9 listed)
- Any significant skin disease at treatment area
- Any medical condition which could interfere with the treatment
- Inability or unwillingness to follow the treatment schedule
- Inability or unwillingness to sign the informed consent
- Pregnant or lactating
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 |
|---|---|---|
| Mirvaso® (brimonidine) topical gel, 0.33%Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older. | Drug | Mirvaso® (brimonidine) topical gel, 0.33% |
| Dysport®Also: Dysport® (abobotulinumtoxinA)Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent. | Drug | Dysport® |
| Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% | Drug | Dysport® in conjunction with Mirvaso |
Primary outcome
Efficacy Assessments for Erythema
Time frame: 6 months
% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Erythema 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Erythema on the 5-point grading scale.
Efficacy Assessments for Flushing
Time frame: 6 months
% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Flushing 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Flushing on the 5-point grading scale.
1 secondary outcome
Safety Assessments
Time frame: 6 months
Results and safety
The study was stopped early (reason given: sponsor asked site to suspend study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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 study testing Mirvaso® (brimonidine) topical gel, 0.33%, Dysport® and Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% in people with Erythema and Flushing Associated With Rosacea, run by Skin Laser & Surgery Specialists.
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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sponsor asked site to suspend study.). Results are not available in the source record.
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?
Efficacy Assessments for Erythema (time frame: 6 months). 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 18 Apr 2023.